PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Feasibility- Rate of early nonresponse
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Feasibility- Rate of early nonresponse
Time Frame: 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
Time Frame: 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 Outcomes
- Weighing Self-Monitoring Adherence(Baseline to 3 months (daily))
- Dietary Self-Monitoring Adherence(Baseline to 3 months (daily))
- Change in Physical Activity(Baseline, 3 months)
- Change in Diet(Baseline, 3 months)
- Acceptability- Rate of attendance at human support sessions(Up to 3 months)
- Weight Change- Percent weight change from baseline to 3 months(Baseline, 3 months)
- Weight Change- Percent weight change from 4 weeks to 3 months(4 weeks, 3 months)
- Acceptability- Overall program satisfaction rating(3 months)
- Activity Goal Adherence(Baseline to 3 months (daily))
- Weight Change- Percent weight change from baseline to 4 weeks(Baseline, 4 weeks)
- Acceptability- Attrition(Up to 3 months)
- Physical Activity Self-Monitoring Adherence(Baseline to 3 months (daily))
- Dietary Goal Adherence(Baseline to 3 months (daily))
- Change in Motivation(Baseline, 1 week, 4 weeks, 3 months)