PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches

The purpose of this initial pilot and feasibility study is to test different digital, behavioral weight loss approaches, with or without human support, using a sequential, multiple assignment, randomized trial (SMART) design. All participants in this pilot trial will receive a 3-month mobile health (mHealth) program. The dose of human support will vary by first- and second-line randomizations. The feasibility, acceptability, and preliminary outcomes for each of the treatment sequences will be assessed.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Overweight and Obesity
• Intervention / Treatment: Behavioral: App; Behavioral: Fully Automated Kick-Off; Behavioral: Human-Enhanced Kick-Off; Behavioral: Check-In; Behavioral: Counseling

Detailed Description

Ninety-nine adults, ages 18-65, with overweight or obesity, will be randomized in total. All participants will receive an mHealth program (App) for program duration that includes activity tracking with a Fitbit, weight tracking with a smart scale, and an app for diet tracking. At baseline, participants will be randomized to either a a) Fully Automated Kick-Off, or b) Human-Enhanced Kick-Off. "Early responders" will continue with to use App, alone. After 4 weeks, "early non-responders" in both arms will be re-randomized once to one of two augmented interventions with human support: Counseling or Check-In. Assessments will occur at baseline, 1 week, 4 weeks, and 3 months to explore feasibility, acceptability, and preliminary outcomes (weight, self-monitoring adherence, behavioral goal adherence).

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current age: 18-65 years
• Lives in North Carolina
• Body mass index (BMI) of 27.5-45 kg/m^2
• Ability to read, write, and speak English
• Ownership of iPhone with a data and texting plan
• Ability to commit to the required counseling sessions (0-5 sessions, based on randomization)
• Is not living a participant or staff member on this trial
• Willingness to be randomized to any of the treatment sequences

Exclusion Criteria:

• Weight loss of more than 10 pounds in the last 6 months that was maintained
• A history of weight loss surgery
• Pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine
• Have Type 1 Diabetes or are currently taking medicine for Type 2 Diabetes
• Have recently been diagnosed or treated for cancer
• Currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months
• Report taking prescription or over the counter medication with a known impact on metabolism or weight
• Report a history of an eating disorder
• History of psychotic disorder or bipolar disorder, or have been hospitalized for depression or other psychiatric disorder within the past 12 months
• History of alcohol or substance abuse
• Current participation in another weight loss program that may interfere with participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fully Automated Kick-Off + App; This arm includes participants who respond to the Fully Automated Kick-Off + App in stage 1. In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program. In stage 2, responders to the Fully Automated Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.	Behavioral: App; Participants will receive an mHealth program.; Behavioral: Fully Automated Kick-Off; As an orientation to the study, participants will receive a fully automated kick-off session.
Experimental: Human-Enhanced Kick-Off + App; This arm includes participants who respond to the Human-Enhanced Kick-Off + App in stage 1. In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program. In stage 2, responders to the Human-Enhanced Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.	Behavioral: App; Participants will receive an mHealth program.; Behavioral: Human-Enhanced Kick-Off; As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Experimental: Fully Automated Kick-Off + App + Check-In; This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1. In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program. In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.	Behavioral: App; Participants will receive an mHealth program.; Behavioral: Fully Automated Kick-Off; As an orientation to the study, participants will receive a fully automated kick-off session.; Behavioral: Check-In; Participants will receive a check-in with a study interventionist.
Experimental: Fully Automated Kick-Off + App + Counseling; This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1. In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program. In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.	Behavioral: App; Participants will receive an mHealth program.; Behavioral: Fully Automated Kick-Off; As an orientation to the study, participants will receive a fully automated kick-off session.; Behavioral: Counseling; Participants will receive counseling from a study interventionist.
Experimental: Human-Enhanced Kick-Off + App + Check-In; This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1. In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program. In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.	Behavioral: App; Participants will receive an mHealth program.; Behavioral: Human-Enhanced Kick-Off; As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.; Behavioral: Check-In; Participants will receive a check-in with a study interventionist.
Experimental: Human-Enhanced Kick-Off + App + Counseling; This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1. In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program. In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.	Behavioral: App; Participants will receive an mHealth program.; Behavioral: Human-Enhanced Kick-Off; As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.; Behavioral: Counseling; Participants will receive counseling from a study interventionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility- Rate of early nonresponse	The rate of early response will be calculated as the number of individuals deemed "early responders" divided by the total number of participants randomized.	4 weeks
Feasibility- Percentage of participants with missing data at 4 weeks	The percentage of participants with missing data at 4 weeks will be calculated as the number of participants who do not complete the 4-week weight assessment divided by the total number of participants randomized.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change- Percent weight change from baseline to 3 months	Percent weight change from baseline to 3 months will be calculated ((3 month weight - baseline weight)/100). Weight will be objectively measured on a scale in the participant's home.	Baseline, 3 months
Weight Change- Percent weight change from baseline to 4 weeks	Percent weight change from baseline to 4 weeks will be calculated ((4 week weight - baseline weight)/100). Weight will be objectively measured on a scale in the participant's home	Baseline, 4 weeks
Weight Change- Percent weight change from 4 weeks to 3 months	Percent weight change from 4 weeks to 3 months will be calculated ((3 month weight - 4 week weight)/100). Weight will be objectively measured on a scale in the participant's home	4 weeks, 3 months
Acceptability- Rate of attendance at human support sessions	The rate of attendance at human support sessions will be calculated as the number of human sessions completed divided by the number of human sessions assigned.	Up to 3 months
Acceptability- Overall program satisfaction rating	Overall program satisfaction will be assessed using a single item, which asks participants to rate their overall satisfaction with the program on a 4-point Likert scale that ranges from "very dissatisfied" to "very satisfied," in which higher scores indicate greater levels of satisfaction.	3 months
Weighing Self-Monitoring Adherence	Number of days of self-weighing over the 3 month period, measured by use of the scale in the participant's home.	Baseline to 3 months (daily)
Dietary Self-Monitoring Adherence	Number of days of complete dietary tracking summed over the 3-month study period, as measured by app use data.	Baseline to 3 months (daily)
Physical Activity Self-Monitoring Adherence	Number of days of physical activity tracking over the 3 month period, as measured by Fitbit tracker wear.	Baseline to 3 months (daily)
Dietary Goal Adherence	Number of days the participant met their daily calorie goal over the 3 month period, as measured by app data.	Baseline to 3 months (daily)
Activity Goal Adherence	Number of days the participant met their active minutes goal over the 3 month period, as measured by app data.	Baseline to 3 months (daily)
Change in Physical Activity	Change in physical activity from baseline to 3 months, as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum.	Baseline, 3 months
Change in Motivation	Change in motivation from baseline to 4 weeks and 3 months, as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for weight management. Six items assess autonomous motivation and six assess controlled motivation using a 7 point Likert scale, in which 1 corresponds to "not at all true" and 7 corresponds to "very true." Items will be averaged to produce scores for autonomous motivation and controlled motivation ranging from 1-7. Higher values on each sub-scale indicate greater levels of that type of motivation. A Relative Autonomous Index (RAI) score will be separately calculated by subtracting the controlled motivation score from the autonomous motivation score. The range of possible RAI scores is -6 to 6.	Baseline, 1 week, 4 weeks, 3 months
Change in Diet	Change in daily caloric intake from baseline to 3 months, as measured using the self- administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on one day at each timepoint.	Baseline, 3 months
Acceptability- Attrition	Attrition will be calculated as the number of intervention participants who did not complete 3-month weight measures divided by the number randomized to treatment.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Academy of Nutrition and Dietetics
• Investigators: Principal Investigator: Caitlin Martinez, MS, RD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Behavioral intervention; SMART (sequential multiple assignment randomized trial)
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Obesity; Weight Loss; Overweight
• Other Study ID Numbers: 23-0396

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