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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UAB Highlands Family and Community Medicine Clinic
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.