NCT05929469Completed
PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
Source: ClinicalTrials.gov · Last updated 30 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 13 Jun 2023
- Start date
- Oct 2023
- Primary completion date
- Apr 2024
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Obesity
- NCT number
- NCT05929469
What you commit to
- Study type: Interventional
- Participants enrolled: 99
- From Oct 2023 to the primary completion date, Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have Type 1 Diabetes or are currently taking medicine for Type 2 Diabetes
- Report taking prescription or over the counter medication with a known impact on metabolism or weight
Other illness
- A history of weight loss surgery
- Pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine
- Have recently been diagnosed or treated for cancer
- 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
Other
- Weight loss of more than 10 pounds in the last 6 months that was maintained
- Currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months
- Current participation in another weight loss program that may interfere with participation in this study
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.