Eatwell Clinical Trial (R01)

Efficacy of a Multi-level Intervention Designed to Promote Adherence to WCRF/AICR Dietary Guidelines for Cancer Prevention

Cancer is a leading cause of death and will affect many people in their lifetimes. Organizations such as the American Cancer Society and the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) have noted that dietary quality is a key factor influencing cancer risk, but most Americans do not meet these dietary guidelines for cancer prevention. The proposed study will enroll adults from the community (n=236 index participants, 236 household members; N = 472) who have low adherence to WCRF/AICR's four dietary guidelines. Participants will be randomized to either nutrition education or the Eatwell intervention. The Eatwell intervention content is focused on helping participants make healthier grocery shopping decisions, eat at home more often to take advantage of the optimal defaults present there, and learn how to navigate temptation when eating away from home. The findings will be relevant not only to the field of cancer prevention, but to the prevention of other diseases for which dietary quality is important.

Study Overview

• Status: Recruiting
• Conditions: Dietary Guidelines; Cancer Prevention
• Intervention / Treatment: Behavioral: Eatwell; Other: Nutrition Education Control Group

Detailed Description

The purpose of this study is to test an intervention that is designed to facilitate adherence to the dietary guidelines for cancer prevention (i.e., increase in intake of fruits, vegetables, and whole grains, and decrease in intake of processed food, red and processed meat, and sugar sweetened beverages). Using a two-arm design, participants will be randomized to receive the "Eatwell" intervention or traditional nutrition education. The Eatwell intervention content is focused on helping participants make healthier grocery shopping decisions, eat at home more often to take advantage of the optimal defaults present there, and learn how to navigate temptation when eating away from home.

Aim 1: Test the hypothesis that there will be a greater increase in adherence to dietary guidelines for cancer prevention among index participants in the Eatwell condition, compared to the traditional nutrition condition. The primary outcome will be a total dietary adherence score, calculated using NCI's standardized scoring system. Grams per day of fruit, vegetables, and fiber; percentage of calorie intake from ultra-processed foods; grams per week of red meat and processed meat; and grams per day of SSBs will be examined individually as secondary outcomes.

Aim 2: Test the hypothesis that there will be greater improvements in biomarkers of inflammation among index participants in the Eatwell condition, compared to the traditional nutrition condition.

Aim 3: Test the hypothesis that adult household members will have greater improvements in dietary adherence (measured by total dietary adherence score, as well as change in individual components of dietary quality, as in Aim 1) when their index participant is randomized to the Eatwell condition, compared to the traditional nutrition condition.

Aim 4: Examine biopsychosocial mediators and moderators of intervention effects.

Aim 5: Exploratory analyses also will be conducted to, for example, examine change over time in the variables assessed as part of the study's assessment battery, understand predictors of change over time, and understand how independent or dependent variables are related to each other.

• Study Type: Interventional
• Enrollment (Estimated): 472
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Coordinator, BA; Phone Number: 724-619-1461; Email: aeu26@drexel.edu
• Study Contact Backup: Name: Meghan L Butryn, PhD; Phone Number: 215-553-7108; Email: mlb34@drexel.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Drexel University
      • Contact: Anna Upman, BA; Phone Number: 724-619-1461; Email: aeu26@drexel.edu
      • Principal Investigator: Meghan L Butryn, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 or older
• Access to technology necessary to receive emails and join videoconferencing meetings
• Ability to read and speak English
• Willingness to be randomized to either study condition, including ability and willingness to attend intervention sessions
• Ability and willingness to attend intervention sessions, receive monthly email messages, and serve in support role if index participant in household is assigned to Eatwell condition
• Able and willing to visit a commercial laboratory partnered with this project (e.g., Labcorp) in order to have their blood drawn at the time of study visits
• Low adherence to WCRF/AICR's four dietary guidelines (operationalized as a level of intake, based on brief self-report questions administered during phone screening, that corresponds to a score of 2 or less in the Shams-White method of dietary adherence scoring)
• Share a household (i.e., a private residence with a shared living space, including kitchen) with an adult who provides informed consent, meets eligibility criteria, and anticipates remaining in this household for the majority of the next 18 months
• Agree that they will not join another intervention study run by this study team in the next 18 months
• Successful completion by self and household member of all enrollment and baseline data collection tasks
• Have an email that they regularly check and willingness to use that for corresponding to study staff
• Weight at baseline of 396 lbs or less, as the digital scales used for measurement are not able to obtain measurements for weights higher than this

Exclusion Criteria:

• A medical or psychiatric condition, including self-reported history of anorexia nervosa or bulimia nervosa, that may limit appropriateness of or ability to comply with dietary recommendations
• A psychiatric condition, including self-reported history of anorexia nervosa or bulimia nervosa, that may make it difficult or inappropriate for household member to serve in support role
• Currently taking medication that can substantively change appetite or eating behavior, including using of a GLP-1 medication
• Planning to enroll in another lifestyle modification program in the next 18 months
• History of bariatric surgery
• Currently pregnant or planning to become pregnant in the next 18 months
• Type 1 Diabetes

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eatwell Condition; Index participant and household members receive Eatwell intervention	Behavioral: Eatwell; The Eatwell intervention content is focused on helping participants make healthier grocery shopping decisions, eat at home more often to take advantage of the optimal defaults present there, and learn how to navigate temptation when eating away from home. The intervention itself involves nutrition education, self-regulation, motivation, and household support. In total, it will last 18 months; index participants will attend 12 workshop sessions that are 90 minutes each. Each workshop session will include approximately 12-16 index participants. The first four sessions will be held weekly in Month 1, and subsequent sessions decrease in frequency. Each index participant will have one enrolled household member who will be asked to join four workshop sessions in a support role: sessions 3, 4, 7, and 10. In these four sessions, household members will receive education about WCRF/AIRC recommendations and training in how to provide instrumental and emotional support to index participants.
Active Comparator: Comparison Condition; Index participants receive nutrition education sessions; household members receive no intervention contact	Other: Nutrition Education Control Group; In the control condition, index participants will receive nutrition education in a series of 12 workshop sessions, following the same schedule as participants in the Eatwell condition. All of the content described under the "nutrition education" component of the Eatwell intervention will be provided. The educational material will be delivered with greater detail and with additional in-session activities, as greater time is devoted to education in the control vs. experimental condition. Participants also will receive monthly educational email messages reiterating key ideas from workshops. Specialized content and activities related to self-regulation and motivation will not be provided in the control condition. If an index participant is randomized to the control condition, their designated household member will have no intervention involvement and will only complete assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dietary adherence score	Index participants will complete the ASA24 for 2 weekdays and 1 weekend day at each assessment point. A research assistant (blind to study condition) will complete the first food recall at baseline with each participant via videoconference. Participants complete recalls independently thereafter unless they indicate a preference for completing with a staff member. Information on dietary intake from the ASA24 will be used to calculate the total dietary adherence score, which is the primary outcome.	0, 6, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intake of targeted food groups	Index participants will complete the ASA24 for 2 weekdays and 1 weekend day at each assessment point. A research assistant (blind to study condition) will complete each food recall with the participant via videoconference, unless a participant indicates that they prefer to complete it independently. The data collected from the ASA24 will be used to examine change in intake of the individual components of the WCRF/AICR guidelines, including grams per day of fruit and vegetables, grams per day of fiber, percentage of calorie intake from ultra-processed foods, grams per week of red meat and processed meat, and grams per days or sugar sweetened drinks.	0, 6, 18 months
Dietary quality	Index participants and their designated household members will each complete the Diet History Questionnaire-III (DHQ-III) once at each assessment point. The DHQ-III is a self-report survey that is completed online via an NCI website. This measure yields a total Healthy Eating Index-2015 (HEI-2015) score as well as specific subcomponents relevant to WCRF/AICR recommendations, such as added sugars.	0, 6, 18 months
Inflammation	Inflammation will be measured, for index participants only, with two biomarkers. Interleukin-6 (IL-6) is a pleiotropic cytokine that plays an important role in the proliferation and differentiation of cells. C-reactive protein (CRP) is produced by the liver in response to circulating inflammatory mediators. CRP measurement will be done with high sensitivity analyses, which detect lower levels of protein than the standard assay. Participants will be asked not to engage in vigorous exercise or weightlifting in the 24 hours prior to the test. At each assessment point, participants will be given a self-report questionnaire to capture acute or chronic conditions that could bias IL-6 or CRP results, such as infection, injury, or certain diseases. This information will be reviewed by study staff blinded to condition to determine if any inflammation data points should be excluded from analyses.	0, 6, 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant age	Age at baseline will be self reported	0 months
Participant weight	Baseline weight will be self reported in pounds	0 months
Participant height	Height will be self reported in feet and inches	0 months
Participant race	Race will be self reported	0 months
Participant ethnicity	Ethnicity will be self reported	0 months
Participant gender	Gender will be self reported	0 months
Participant biological sex	Biological sex will be self reported	0 months
Participant household income	Household income at baseline will be self reported	0 months
Objectively measured weight	Each index participant will be provided with a Withings wireless scale, accurate to >0.2 kg, that transmits information directly to study staff. Scale information will be piped from the device to REDCap. Participants will be instructed to weigh themselves in the morning, after voiding urine but before eating, for three consecutive days at each assessment point, with the scale on a flat, hard surface. Data will be checked for outliers and averaged at each time point for each participant. BMI will be calculated based on self-reported height and objectively measured weight.	0, 6, 18 months
Food insecurity	This will be assessed with the USDA's Household Food Security Survey and will be dichotomized as food secure vs. low or very low security.	0 months
Neighborhood food environment	The neighborhood food environment will be assessed through the use of the modified Retail Food Environment Index (mRFEI) score, sourced from the CDC and census tract. Participant addresses will be used to determine their mRFEI score.	0 months
The proportion of meals and snacks sourced from grocery stores	This will be measured with the "Source" module on ASA24 food recalls, which tags each food entry with a source (e.g., convenience store, fast food, street vendor, etc.). Participants will be categorized into tertiles based on proportion of diet sourced from grocery stores.	0, 6, 18 months
Treatment Acceptability	Treatment Acceptability will be measured at 6 and 18 months using the Treatment Acceptability Questionnaire. This measure was created by the study team.	6, 18 months
Self-regulation	To measure use of self-regulation strategies, participants will be asked to rate the frequency with which they used each strategy in the past month. Change in use of intervention-targeted strategies will be examined.	0, 6, 18 months
Autonomous Motivation	Autonomous motivation for dietary change will be examined with the Treatment Self-Regulation Questionnaire.	0, 6, 18 months
Supportive Accounability	Supportive accountability will be measured with the dietary items of the Supportive Accountability Measure.	0, 6, 18 months
Social Support	Social support for healthy eating from household members will be measured with select items adapted from Sallis's Social Support for Diet Survey and the Quality of Interactions survey.	0, 6, 18 months
Physical Acitvity	Physical activity will be measured with the International Physical Activity Questionnaire (Short-Form).	0, 6, 18 months
Hedonic hunger	Hedonic hunger will also be measured through the Power of Food Scale.	0, 6, 18 months

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: November 6, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: R01CA288323 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All deidentified data will be placed in a public repository.
• IPD Sharing Time Frame: Within 12 months after study completion.
• IPD Sharing Access Criteria: Public availability
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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