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

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.

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).

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