Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention (EatWell)

Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. One promising pathway for improving dietary adherence is to target grocery shopping habits, i.e., foods purchased for consumption at home. Two-thirds of daily food intake is sourced from or eaten in the home, so improving the quality of the home food environment should improve overall diet quality. When healthy foods are purchased and unhealthy foods are not, minimal self-control is needed to make healthy eating choices in the home. At the point of purchase, it is difficult to resist the temptation of palatable foods, but interventions might facilitate healthy choices by promoting dietary goal salience in real-time while grocery shopping, enhancing motivation to make and sustain changes to the diet, and increasing household support and accountability for healthy food purchasing. The proposed study will enroll adults who have low adherence to cancer prevention dietary recommendations. All participants will attend a nutrition education workshop conducted via Zoom. For 20 weeks, all participants also will receive once weekly reminders and recommendations for food purchasing via an app. The study will experimentally test four additional intervention components: location-triggered messages, coaching monitoring of food purchases, benefit of change content, and household member involvement. The preliminary aim of the study is to assess feasibility and acceptability of the intervention components. The primary aim of the study is to quantify the effect of each intervention component, individually and in combination, on dietary intake (assessed with 24-hour food recalls). The overarching goal of this project is to optimize this mHealth intervention, which can be tested in the future in a fully powered clinical trial.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Location-triggered notification; Behavioral: Coach monitoring; Behavioral: Reflections on benefits of change; Behavioral: Household support

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• 18 years or older
• Fluent in English
• Low adherence to cancer prevention dietary guidelines, operationalized as a score of ≤ 2 out of 4 using the National Cancer Institute method for assessing adherence to World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) lifestyle recommendations. This three-level scoring system (meeting/partially meeting/not meeting each recommendation) includes 4 items specific to diet. Participants must score equal or less than 2, meaning that they are fully meeting recommendations for no more than 2 of the 4 dietary recommendations.
• Performs the majority of the household's food shopping, and do so at stores that can passively stream item-level data from a store loyalty card to the Information Machine API (e.g., Walmart, Target, ShopRite, Wegman's, etc.)
• Has a smartphone with iOS or Android operating system that is compatible with the program app
• Lives in a household with at least one other adult who consents to being randomized to possibly receive messages on his/her own cell phone through the program app

Exclusion criteria

• Medical condition or psychiatric condition (e.g., active substance abuse, eating disorder) that may limit appropriateness of or ability to comply with program dietary recommendations
• Planning to enroll in another lifestyle modification program in the next 6 months
• Bariatric surgery history
• Currently pregnant or breastfeeding or planning to become pregnant in the next 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LOCATION TRIGGERED MESSAGING; Weekly message is triggered when arriving at grocery store.	Behavioral: Location-triggered notification; If participants are randomized to have this component ON, the app will send the notification when the participant's smartphone is within a 50-meter "geofence" around designated grocery stores. No more than one notification will be sent per week. Mindfulness of program goals in the moment of decision making is expected to facilitate program-consistent food purchasing behaviors. Participants assigned to have location-triggered message delivery OFF will receive their weekly "recommendations and reminders" messages at standard times throughout the week. The content of the messages will not differ according to whether this component is ON vs. OFF.
Experimental: COACH MONITORING; Coaches view grocery purchases via web portal, send weekly messages about purchases they observe, and conduct three brief phone calls to discuss purchases.	Behavioral: Coach monitoring; Coaches will monitor participant food purchases via a dashboard for viewing purchase data, and send messages designed to provide feedback and enhance supportive accountability for program goals. The messages will provide reinforcement for purchases consistent with program goals and express concern for areas in which adherence is low. Participants assigned to have this component OFF will not receive these extra messages or phone calls, and their food purchases will only be viewed by research staff for research outcome assessment purposes.
Experimental: BENEFITS OF CHANGE; Attend an extra workshop session and three phone calls to identify and reflect on benefits of dietary change. Content added to standard weekly messages about benefits of change.	Behavioral: Reflections on benefits of change; Participants will reflect on anticipated benefits of purchasing healthy foods, consistent with motivational interviewing and self-determination theory. Message content will be personalized as follows: During the initial workshop, all participants will complete an exercise identifying benefits of healthy eating that are important to them. Message content will then be programmed to be personalized according to anticipated rewards important to that participant. Participants assigned to have this intervention component OFF will not have content about anticipated benefits of change added to any messages.
Experimental: HOUSEHOLD SUPPORT; An adult household member attends one workshop session and three phone calls with the index participant. This household member receives weekly text messages for 20 weeks about program goals and ways to support the index participant.	Behavioral: Household support; If participants are assigned to have household support ON, one adult in the household will receive weekly text messages designed to elicit support for changing food purchases. In addition, the index participant and household member will be invited to participate in one extra workshop session and three brief coaching calls focused on household support. If participants are assigned to have this OFF, household members will have no program involvement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1a. Dietary Intake: ASA24 (Fiber)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of fiber per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
1b. Primary Outcome: Dietary Intake ASA24 (Fruit/Veg)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in number of cups of fruits and vegetables per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
1c. Primary Outcome: Dietary Intake ASA24 (Red Meat)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of red meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
1d. Primary Outcome: Dietary Intake ASA24 (Processed Meat)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of processed meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
1e. Primary Outcome: Dietary Intake ASA24 (Added Sugars)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of added sugars consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
1f. Primary Outcome: Dietary Intake ASA24 (Sodium)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in mg of sodium consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
1g. Primary Outcome: Dietary Intake ASA24 (Fat)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of saturated fat consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
1h. Primary Outcome: Dietary Intake ASA24 (Sugar-Sweetened Beverages)	In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in oz of sugar sweetened beverages consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2a: Dietary Intake: DHQ-III (Fiber)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of fiber per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2b. Dietary Intake: DHQ-III (Fruits/Veg)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in cups of fruits and vegetables per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2c. Dietary Intake: DHQ-III (Red Meat)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of red meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2d. Dietary Intake: DHQ-III (Processed Meat)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of processed meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2e. Dietary Intake: DHQ-III (Added Sugars)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of added sugars consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2f. Dietary Intake: DHQ-III (Sodium)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in mg of sodium consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2g. Dietary Intake: DHQ-III (Fat)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of saturated fat per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
2h. Dietary Intake: DHQ-III (Sugar-Sweetened Beverages)	In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in ounces of sugar-sweetened beverages per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal Salience	Goal salience while grocery shopping was measured using an investigator-developed self-report questionnaire. Participants rated 3 questions pertaining to salience of health goals during grocery shopping on a sliding scale from 0 (not at all) to 100 (very much): Scores on these three items were averaged to compute a global Goal Salience total score (range = 0-100), with higher scores indicating higher goal salience. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Supportive Accountability	Supportive accountability was measured using 5 items adapted from the Perceptions of Accountability Scale (Chhabria et al., 2020). Participants rated 5 items (e.g., "I feel accountable to others for meeting my dietary goals") on a sliding scale from 0 (not at all) to 100 (very much). Scores on the 5 items were averaged to produce a global Supportive Accountability total score (range 0-100), with higher scores indicating higher perceived supportive accountability to others for dietary/healthy eating goals. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Autonomous Motivation	Motivation for healthy eating was measured using 10 items adapted from the Treatment Self-Regulation Questionnaire (Levesque et al., 2007). Using the question stem "The reason I would follow a healthy diet is...", participants rated items on a scale from 1 (not at all true) to 7 (very true). Six items were averaged to create a subscale of autonomous Motivation for healthy eating (range 1-7), with higher scores on each subscale indicated higher Autonomous Motivation. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
External Motivation	Motivation for healthy eating was measured using 10 items adapted from the Treatment Self-Regulation Questionnaire (Levesque et al., 2007). Using the question stem "The reason I would follow a healthy diet is...", participants rated items on a scale from 1 (not at all true) to 7 (very true). Four items were averaged to create the subscale of external Motivation for healthy eating (range 1-7). Higher scores on each subscale indicated higher external motivation for healthy eating. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Social Support (Encouragement)	Participants responded to 10 items adapted from the Sallis Social Support for Diet Questionnaire (Sallis et al., 1987). Using the question stem "The other adult(s) in my household...", participants rated items on a scale from 1 (none) to 5 (very often), with 6 indicating "Not Applicable" (N/A; recoded as 1). Five items were summed to measure encouragement of healthy eating (e.g., "complimented me on changing my eating habits"; range 5-25), with higher scores indicating higher encouragement. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Social Support (Discouragement)	Participants completed the Sallis Social Support for Diet Questionnaire (Sallis et al., 1987). Using the question stem "The other adult(s) in my household...", participants rated items on a scale from 1 (none) to 5 (very often). 6 indicated "Not Applicable," which was recoded as 1 (none). Five items (e.g., "ate unhealthy foods in front of me") were summed to create the Discouragement of Healthy Eating subscale (range 5-25); higher scores indicated higher discouragement. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Quality of Household Relationship	Quality of the household relationship was measured using 5 items adapted from the Relationship Assessment Scale (Hendrick, 1988). Items assessed the quality of their relationship with the person who served as their household support partner in the Eatwell program (e.g., "How well does this person meet your needs") on a scale from 1 (Low) to 5 (High). Scores on the 5 items were averaged to calculate a Relationship Quality total score (range 1-5); higher scores indicated higher perceived relationship quality. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline
Weight History	Weight history was measured using an investigator developed questionnaire. Participants answered the following question about weight history in the past 6 months: "Which of these statements best describe what has happened to your weight during the past 6 months?" Answer choices included: (1) My weight has stayed the same; (2) I've been losing weight; (3) I've been gaining weight; or (4) My weigh has fluctuated a lot. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 weeks (Baseline)
Dietary Restraint	Dietary restraint was measured using the Three Factor Eating Questionnaire (Cappelleri et al., 2009). For items #1-20, participants rated statements on a 4-point Likert scale from 1 (definitely true) to 4 (definitely false; reverse coded). Item 21 assessed overall restraint on an 8-point scale from 1 (no restraint) to 8 (total restraint), recoded such that 1-2=1; 3-4=2; 5-6=3; and 7-8=4 (so that all items ranged 1-4). Six items were summed to calculate a Restraint score (range = 6-24); higher scores indicated more restraint. This pilot study used a factorial design, with 16 conditions and ~4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Uncontrolled Eating	Uncontrolled eating was measured using the subscale of the Three Factor Eating Questionnaire - 21 item (Cappelleri et al., 2009). Responses ranged from 1 (definitely true) to 4 (definitely false). Items were reverse coded and summed to calculate an uncontrolled eating (range = 6-24), with higher scores indicating higher uncontrolled eating. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Emotional Eating	Emotional eating was measured using the subscale of the Three Factor Eating Questionnaire - 21 item (Cappelleri et al., 2009). Responses ranged from 1 (definitely true) to 4 (definitely false). Six were reverse coded and summed to calculate an emotional eating (range = 6-24), with higher scores indicating higher emotional eating. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Dietary Intake - FFQ (Guideline 1)	A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 1 (i.e., fruits, vegetables, whole grains, and bean/ legumes ), participants rated how frequently they consumed these categories (4 items) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). A total guideline 1 score was calculated as the average of responses to the 4 items (range 0-5), where higher scores indicate more frequently eating fruits, vegetables, whole grains, and beans/legumes. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 2)	A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 2 (i.e., processed foods high in fat, starches, sugars), participants rated how frequently they consumed foods from these categories (6 items) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). A total guideline 2 score was calculated as the average of responses to the 6 items (range 0-5), where higher scores indicate more frequently eating processed foods. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 3)	A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 3 (i.e., red and processed meat), participants rated how frequently they consumed these categories (2 items) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). A total guideline 3 score was calculated as the average of responses to the 2 items (range 0-5), where higher scores indicate more frequently eating red and processed meats. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 4)	A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 4 (i.e., sugar-sweetened drinks), participants rated how frequently they consumed these drinks (1 item) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). Given intake for guideline 4 was assessed with only 1 item on the FFQ, the total guideline 4 score was the response to this single item (range 0-5), where higher scores indicate more frequently drinking sugar-sweetened drinks. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	0, 10, 20 weeks
Treatment Acceptability: 10 Weeks	An adapted 8- item version of the Treatment Acceptability Questionnaire (Hunsley, 1993) was used to assess intervention acceptability. Eight questions probed their program experience and how helpful/acceptable they found various intervention components (e.g., "How effective do you think this program is?"). Responses ranged from 1 = no/low acceptability to 7 = high acceptability. A total score was calculated as the average across all 8 items (range 8-56) where higher scores indicate greater treatment acceptability. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	10 weeks (mid-treatment)
Treatment Acceptability: 20 Weeks	An adapted 8- item version of the Treatment Acceptability Questionnaire (Hunsley, 1993) was used to assess intervention acceptability. Eight questions probed their program experience and how helpful/acceptable they found various intervention components (e.g., "How effective do you think this program is?"). Responses ranged from 1 = no/low acceptability to 7 = high acceptability. A total score was calculated as the average across all 8 items (range 8-56) where higher scores indicate greater treatment acceptability. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	20 weeks (post-treatment)
Goals and Stages of Change- Household Member	Two self-report items developed by the investigator assessed the goals of the selected household member at baseline: "On a scale of 1-100, how important is it that you adopt healthier eating habits right now?". Item 2 asked "On a scale of 1-100, how important is it that you help your household member adopt healthier eating habits right now?". For each item, household members responded on a scale from 0 - not important at all, 50 - about as important as most of the other things I would like to achieve now, to 100 - most important thing in my life now. Items were analyzed at individually, and each item ranged 0-100 where higher scores indicate higher importance of the associated goal.	0 weeks
Dietary Intake-household Member	Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. Household members are presented with 13 categories of foods that are relevant for each of the cancer prevention dietary guidelines (e.g., "Fresh, frozen, or canned fruit (not dried or fruit juice)", "Red meats such as beef, pork, lamb"). They rated how frequently they consume each category during an average week over the past month. Scale is as follows: 0 = Never, 1 = less than per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. The 13 items are then classified into the guideline they pertain to and total guidelines scores were calculated as the average of responses to all relevant items (range 0-5) where higher scores indicate more frequently eating items associated with that nutrition guideline.	0, 20 weeks
Treatment Acceptability - Household	Household members completed the same adapted 8- item version of the Treatment Acceptability Questionnaire (Hunsley, 1993) as index participants. This measured acceptability of the intervention. Household members were presented with 8 questions about their experience during the program and how helpful/acceptable they found various intervention components to be (e.g., "How effective do you think this program is?", "How trustworthy do you think your coach was?". Household members responded to each question on a 7-point Likert scale where 1 = no/low acceptability and 7 = high acceptability. A total score was calculated as the average across all 8 items (range 8-56) where higher scores indicate greater treatment acceptability.	20 weeks
Dietary Intake- Household Member - FFQ (Guideline 1)	Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 1 of the dietary cancer prevention guidelines (i.e., intake of fruits, vegetables, whole grains, and bean/ legumes ), household members rated how frequently they consumed these categories (4 items) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 1 score was calculated as the average of responses to the 4 items (range 0-5), where higher scores indicate more frequently eating fruits, vegetables, whole grains, and beans/legumes.	0, 20 weeks
Dietary Intake - Household Member - FFQ (Guideline 2)	Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 2 of the dietary cancer prevention guidelines (i.e., intake of processed foods high in fat, starches, or sugars), household members rated how frequently they consumed foods that fell into these categories (6 items) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 2 score was calculated as the average of responses to the 6 items (range 0-5), where higher scores indicate more frequently eating processed foods high in far, starches, and sugars.	0, 20 weeks
Dietary Intake-household Member - FFQ (Guideline 3)	Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 3 of the dietary cancer prevention guidelines (i.e., intake of red and processed meats), household members rated how frequently they consumed red meats and processed meats (2 items) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 3 score was calculated as the average of responses to the 2 items (range 0-5), where higher scores indicate more frequently eating red and processed meats.	0, 20 weeks
Dietary Intake-household Member - FFQ - Guideline 4	Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 4 of the dietary cancer prevention guidelines (i.e., intake of sugar sweetened beverages), household members rated how frequently they consumed sugar sweetened beverages (1 item) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 4 score was calculated as the response to this item (range 0-5), where higher scores indicate more frequently drinking sugar sweetened beverages.	0, 20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to AICR Cancer Prevention Guidelines: Guideline 1	To calculate adherence to the NCI dietary recommendations for guideline 1 (fruits, vegetables, and fiber), the WCRF/AICR scoring method from Turati et al., 2020 was used. This method has pre-defined cutoff values for the recommended levels of intake for each nutrient that is expected to have clinical significance. Based on their self-reported levels of dietary intake for whole grains, beans, fruits, and vegetable consumption, participants receive adherence scores for each dietary domain of 0 (failure to meet recommendation), 0.5 (partially meeting recommended levels), or 1 (fully meeting recommended level of intake). Guideline 1 (fruits, vegetables, and fiber) total adherence score (range 0-1) was calculated as the average of adherence scores for whole grains, beans, fruits, and vegetable consumption.	Baseline and post-treatment (0 and 20 weeks)
Adherence to AICR Cancer Prevention Guidelines: Guideline 2	To calculate adherence to the NCI dietary recommendations for guideline 2 (intake of processed foods), the WCRF/AICR scoring method from Turati et al., 2020 was used. This method has pre-defined cutoff values for the recommended levels of intake for each nutrient that is expected to have clinical significance. Based on their self-reported levels of intake of added sugar, saturated fat, and sodium in processed foods, participants receive adherence scores for each dietary domain of 0 (failure to meet recommendation), 0.5 (partially meeting recommended levels), or 1 (fully meeting recommended level of intake). Guideline 2 total adherence score (range 0-1) was calculated as the average of adherence scores for consumption of added sugar, saturated fat, and sodium in processed foods.	Baseline and post-treatment (0 and 20 weeks)
Adherence to AICR Cancer Prevention Guidelines: Guideline 3	To calculate adherence to the NCI dietary recommendations for guideline 3 (intake of red and processed meats), the WCRF/AICR scoring method from Turati et al., 2020 was used. This method has pre-defined cutoff values for the recommended levels of intake for each nutrient that is expected to have clinical significance. Based on their self-reported levels of intake of red and processed meats, participants receive adherence scores for each dietary domain of 0 (failure to meet recommendation), 0.5 (partially meeting recommended levels), or 1 (fully meeting recommended level of intake). Guideline 3 total adherence score (range 0-1) was calculated as the average of adherence scores for red and processed meat intake.	Baseline and post-treatment (0 and 20 weeks)
Adherence to AICR Cancer Prevention Guidelines: Guideline 4	To calculate adherence to the NCI dietary recommendations for guideline 4 (intake of sugar sweetened beverages), the WCRF/AICR scoring method from Turati et al., 2020 was used. This method has pre-defined cutoff values for the recommended levels of intake for each nutrient that is expected to have clinical significance. Based on their self-reported levels of intake of sugar sweetened beverages, participants receive an adherence score of 0 (failure to meet recommendation), 0.5 (partially meeting recommended levels), or 1 (fully meeting recommended level of intake). Guideline 4 total adherence score (range 0-1) was calculated as adherence score for intake of sugar sweetened beverages.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Fruit	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated grocery stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Fruit purchases were calculated by tabulating the percent of fruit purchases divided by total purchases. Scores range from 0-100%. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Vegetables	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated grocery stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Vegetable purchases were calculated by tabulating the percent of fruit purchases divided by total purchases. Scores range from 0-100%. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Meat	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated grocery stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Meat purchases were calculated by tabulating the percent of meat purchases divided by total purchases. Scores range from 0-100%. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Grains and Beans	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated grocery stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Grains/beans purchases were calculated by tabulating the percent of grains and beans purchases divided by total purchases. Scores range from 0-100%.This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Sugar-Sweetened Beverages	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Sugar-sweetened beverage (SSB) purchases were calculated by tabulating the percent of SSB purchases divided by total purchases. Scores range from 0-100%. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Sweets	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated grocery stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Sweets purchases were calculated by tabulating the percent of meat purchases divided by total sweets purchases. Scores range from 0-100%. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Snacks	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated grocery stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Snack purchases were calculated by tabulating the percent of snack purchases divided by total purchases. Scores range from 0-100%. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)
Grocery Store Purchases - Other Processed Foods	To measure grocery purchasing, an API transferred participants' item-level food purchases to the study database whenever they shopped at designated grocery stores (Wegmans, ShopRite, Target, and Walmart). Each item in the shopping trip was linked to an existing nutrition databases (e.g., FNDDS) to categorize it into a NCI relevant category and to pull nutritional information. Processed food purchases were calculated by tabulating the percent of processed food purchases divided by total purchases. Scores range from 0-100%.This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.	Baseline and post-treatment (0 and 20 weeks)

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Meghan L Butryn, PhD, Drexel University

Publications and helpful links

General Publications

• Horgan OZ, Crane NT, Forman EM, Milliron BJ, Simone NL, Zhang F, Butryn ML. Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 24;11(6):e39669. doi: 10.2196/39669.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1R21CA252933 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No