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

University of North Carolina (UNC)

Status: Completed

Conditions: Overweight; Overweight and Obesity; Obesity

Treatments: Behavioral: App; Behavioral: Check-In; Behavioral: Human-Enhanced Kick-Off; Behavioral: Counseling; Behavioral: Fully Automated Kick-Off

Study type: Interventional

Funder types: Other

Identifiers

NCT05929469

23-0396

Details and patient eligibility

About

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.

Full 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).

Enrollment: 99 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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99 participants in 6 patient groups

Fully Automated Kick-Off + App

Experimental group

Description:

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.

Treatment:

Behavioral: Fully Automated Kick-Off

Behavioral: App

Human-Enhanced Kick-Off + App

Experimental group

Description:

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.

Treatment:

Behavioral: Human-Enhanced Kick-Off

Behavioral: App

Fully Automated Kick-Off + App + Check-In

Experimental group

Description:

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.

Treatment:

Behavioral: Fully Automated Kick-Off

Behavioral: Check-In

Behavioral: App

Fully Automated Kick-Off + App + Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Fully Automated Kick-Off

Behavioral: Counseling

Behavioral: App

Human-Enhanced Kick-Off + App + Check-In

Experimental group

Description:

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.

Treatment:

Behavioral: Check-In

Behavioral: Human-Enhanced Kick-Off

Behavioral: App

Human-Enhanced Kick-Off + App + Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Counseling

Behavioral: Human-Enhanced Kick-Off

Behavioral: App