NCT05929469

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Overweight
• Obesity
• Overweight and Obesity

Interventions

Type	Name	Description
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	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.
BEHAVIORAL	Counseling	Participants will receive counseling from a study interventionist.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2023-07-03
• Last updated: 2024-05-30

Locations

1 site across 1 country: United States