RECRUITING

Development of an Inclusive Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. 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.

Official Title

Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial

Quick Facts

Study Start:2026-01-15
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-75 years of age
  2. * BMI of 27 kg/m2 or greater for ambulatory individuals and 22 kg/m2 for individuals with spinal cord injury. Adjustments will be calculated for those with amputations and/or limb indifference
  3. * at risk for developing type 2 diabetes (prediabetes)
  4. * One or more physical or mobility disabilities
  5. * Stable medication type and dosage for 3 or more months for medications likely to affect body weight and/or appetite
  6. * Willing to complete requirements for participation
  1. * Pregnant, planning to become pregnant or breastfeeding
  2. * Currently taking medication(s) for weight loss
  3. * Medical history of Type 1 or 2 Diabetes, using exogenous insulin, using prescription or OTC weight loss medications within the past 3 months, current alcohol or drug abuse or dependence, smoker with unstable habits in the past 3 months, pacemaker or other life-threatening medical implant, eating disorder(s)

Contacts and Locations

Study Contact

Omer Faruq, MS
CONTACT
205-518-8292
ofaruq@uab.edu

Principal Investigator

Christine Ferguson, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

Wellness Health and Research Facility (WHARF)
Birmingham, Alabama, 35209
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Christine Ferguson, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2026-01-15
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2026-01-15
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • SMART
  • diet
  • exercise
  • weight loss
  • disabilities

Additional Relevant MeSH Terms

  • Disabilities
  • Obesity and Overweight
  • Prediabetes