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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Overweight, Obesity, Overweight and Obesity

Intervention / Treatment
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* Behavioral: App
* Behavioral: Fully Automated Kick-Off
* Behavioral: Human-Enhanced Kick-Off
* Behavioral: Check-In
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This initial pilot and feasibility study uses a sequential, multiple assignment, randomized trial (SMART) design to test digital, behavioral weight loss approaches, with or without human support. Sequential randomization will occur at baseline and at the end of 4 weeks. At baseline, participants will be randomized to receive a standard mHealth program and either a a) Fully Automated Kick-Off session, or b) Human-Enhanced Kick-Off session. Using an a priori decision rule after 4 weeks, those for whom the intervention is not effective will be re-randomized and receive one of two doses of human support. The final assessment will be at 3 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fully Automated Kick-Off + App<br>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<br>* Participants will receive an mHealth program.<br>Behavioral: Fully Automated Kick-Off<br>* As an orientation to the study, participants will receive a fully automated kick-off session.<br>|
| Experimental: Human-Enhanced Kick-Off + App<br>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<br>* Participants will receive an mHealth program.<br>Behavioral: Human-Enhanced Kick-Off<br>* As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.<br>|
| Experimental: Fully Automated Kick-Off + App + Check-In<br>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<br>* Participants will receive an mHealth program.<br>Behavioral: Fully Automated Kick-Off<br>* As an orientation to the study, participants will receive a fully automated kick-off session.<br>Behavioral: Check-In<br>* Participants will receive a check-in with a study interventionist.<br>|
| Experimental: Fully Automated Kick-Off + App + Counseling<br>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<br>* Participants will receive an mHealth program.<br>Behavioral: Fully Automated Kick-Off<br>* As an orientation to the study, participants will receive a fully automated kick-off session.<br>Behavioral: Counseling<br>* Participants will receive counseling from a study interventionist.<br>|
| Experimental: Human-Enhanced Kick-Off + App + Check-In<br>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<br>* Participants will receive an mHealth program.<br>Behavioral: Human-Enhanced Kick-Off<br>* As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.<br>Behavioral: Check-In<br>* Participants will receive a check-in with a study interventionist.<br>|
| Experimental: Human-Enhanced Kick-Off + App + Counseling<br>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<br>* Participants will receive an mHealth program.<br>Behavioral: Human-Enhanced Kick-Off<br>* As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.<br>Behavioral: Counseling<br>* Participants will receive counseling from a study interventionist.<br>|

What is the study measuring?
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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- Attrition | Attrition will be calculated as the number of intervention participants who completed 3-month measures divided by the number who consented to participate. | 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 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 a week day and a weekend day at each timepoint. | Baseline, 3 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral intervention, SMART (sequential multiple assignment randomized trial)