NCT04745572Completed
Development of an Adaptive Treatment for Weight Loss in People With Prediabetes
Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 4 Feb 2021
- Start date
- 14 May 2021
- Primary completion date
- 21 Nov 2023
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Obesity
- NCT number
- NCT04745572
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 14 May 2021 to the primary completion date, 21 Nov 2023
- 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.
Other
- Pregnant, planning to become pregnant, or breastfeeding
- uncontrolled hypo or hyperthyroidism
Who the study is looking for
- 18-75 years of age
- BMI of 27 kg/m2 or greater
- at risk for developing type 2 diabetes (prediabetes)
Age in the registry: 18 years to 75 years · Sex: All · Accepts 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 |
|---|---|---|---|
| UAB Highlands Family and Community Medicine Clinic Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.