Clinical trial NCT05929469: PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
Official title: PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Overweight and Obesity
Keywords: Behavioral intervention
SMART (sequential multiple assignment randomized trial)
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Academy of Nutrition and Dietetics
First posted: 2023-07-03
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This initial pilot and feasibility study uses a sequential, multiple assignment, randomized trial (SMART) design to test digital, behavioral weight loss approaches, with or without human support. Sequential randomization will occur at baseline and at the end of 4 weeks. At baseline, participants will be randomized to receive a standard mHealth program and either a a) Fully Automated Kick-Off session, or b) Human-Enhanced Kick-Off session. Using an a priori decision rule after 4 weeks, those for whom the intervention is not effective will be re-randomized and receive one of two doses of human support. The final assessment will be at 3 months.
Primary purpose: TREATMENT

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).

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
* Current participation in another weight loss program that may interfere with participation in this study

Primary outcomes:
measure: Feasibility- Rate of early nonresponse
timeFrame: 4 weeks
measure: Feasibility- Percentage of participants with missing data at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Weight Change- Percent weight change from baseline to 3 months
timeFrame: Baseline, 3 months
measure: Weight Change- Percent weight change from baseline to 4 weeks
timeFrame: Baseline, 4 weeks
measure: Weight Change- Percent weight change from 4 weeks to 3 months
timeFrame: 4 weeks, 3 months
measure: Acceptability- Rate of attendance at human support sessions
timeFrame: Up to 3 months
measure: Acceptability- Attrition
timeFrame: Up to 3 months
measure: Acceptability- Overall program satisfaction rating
timeFrame: 3 months
measure: Weighing Self-Monitoring Adherence
timeFrame: Baseline to 3 months (daily)
measure: Dietary Self-Monitoring Adherence
timeFrame: Baseline to 3 months (daily)
measure: Physical Activity Self-Monitoring Adherence
timeFrame: Baseline to 3 months (daily)
measure: Dietary Goal Adherence
timeFrame: Baseline to 3 months (daily)
measure: Activity Goal Adherence
timeFrame: Baseline to 3 months (daily)
measure: Change in Diet
timeFrame: Baseline, 3 months
measure: Change in Physical Activity
timeFrame: Baseline, 3 months
measure: Change in Motivation
timeFrame: Baseline, 1 week, 4 weeks, 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Caitlin Martinez, MS, RD
role: PRINCIPAL_INVESTIGATOR
References: