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

Not Applicable

Completed

• Conditions: Overweight; Obesity; Overweight and Obesity
• Interventions: Behavioral: App; Behavioral: Fully Automated Kick-Off; Behavioral: Human-Enhanced Kick-Off; Behavioral: Check-In; Behavioral: Counseling

• Registration Number: NCT05929469
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-03
• Status Verified: 2023-10
• Study Start: 2023-10-02
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Human-Enhanced Kick-Off + App + Check-In	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.
Fully Automated Kick-Off + App + Check-In	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.
Human-Enhanced Kick-Off + App + Check-In	App	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.
Fully Automated Kick-Off + App	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.
Fully Automated Kick-Off + App	Fully Automated Kick-Off	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.
Human-Enhanced Kick-Off + App	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.
Human-Enhanced Kick-Off + App	Human-Enhanced Kick-Off	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.
Fully Automated Kick-Off + App + Check-In	App	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.
Fully Automated Kick-Off + App + Check-In	Fully Automated Kick-Off	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.
Fully Automated Kick-Off + App + Counseling	Fully Automated Kick-Off	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.
Human-Enhanced Kick-Off + App + Check-In	Human-Enhanced Kick-Off	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.
Human-Enhanced Kick-Off + App + Counseling	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.
Fully Automated Kick-Off + App + Counseling	App	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.
Fully Automated Kick-Off + App + Counseling	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.
Human-Enhanced Kick-Off + App + Counseling	App	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.
Human-Enhanced Kick-Off + App + Counseling	Human-Enhanced Kick-Off	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.

Primary Outcome Measures

Name	Time	Method
Feasibility- Rate of early nonresponse	4 weeks	The rate of early response will be calculated as the number of individuals deemed "early responders" divided by the total number of participants randomized.
Feasibility- Percentage of participants with missing data at 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Weighing Self-Monitoring Adherence	Baseline to 3 months (daily)	Number of days of self-weighing over the 3 month period, measured by use of the scale in the participant's home.
Dietary Self-Monitoring Adherence	Baseline to 3 months (daily)	Number of days of complete dietary tracking summed over the 3-month study period, as measured by app use data.
Change in Physical Activity	Baseline, 3 months	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.
Change in Diet	Baseline, 3 months	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.
Acceptability- Rate of attendance at human support sessions	Up to 3 months	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.
Weight Change- Percent weight change from baseline to 3 months	Baseline, 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.
Weight Change- Percent weight change from 4 weeks to 3 months	4 weeks, 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
Acceptability- Overall program satisfaction rating	3 months	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.
Activity Goal Adherence	Baseline to 3 months (daily)	Number of days the participant met their active minutes goal over the 3 month period, as measured by app data.
Weight Change- Percent weight change from baseline to 4 weeks	Baseline, 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
Acceptability- Attrition	Up to 3 months	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.
Physical Activity Self-Monitoring Adherence	Baseline to 3 months (daily)	Number of days of physical activity tracking over the 3 month period, as measured by Fitbit tracker wear.
Dietary Goal Adherence	Baseline to 3 months (daily)	Number of days the participant met their daily calorie goal over the 3 month period, as measured by app data.
Change in Motivation	Baseline, 1 week, 4 weeks, 3 months	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States