Clinical trial NCT06976307: Development of an Inclusive Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
Official title: Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disabilities
Obesity and Overweight
Prediabetes
Keywords: SMART
diet
exercise
weight loss
disabilities
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18-75 years of age
* 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
* at risk for developing type 2 diabetes (prediabetes)
* One or more physical or mobility disabilities
* Stable medication type and dosage for 3 or more months for medications likely to affect body weight and/or appetite
* Willing to complete requirements for participation

Exclusion Criteria:

* Pregnant, planning to become pregnant or breastfeeding
* Currently taking medication(s) for weight loss
* 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)

Primary outcomes:
measure: Change in glucose
timeFrame: Baseline & Week 16
measure: Changes in body weight
timeFrame: Baseline, Week4, and Week 16
Secondary outcomes:
measure: Changes in fat mass
timeFrame: Baseline & Week 16
measure: Change in insulin
timeFrame: Baseline & Week 16
measure: Changes in lipids
timeFrame: Baseline & Week 16
measure: Changes in QUICKI index
timeFrame: Baseline & Week 16
measure: Changes in overall strength
timeFrame: Baseline & Week 16
measure: Changes in aerobic fitness
timeFrame: Baseline & Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Wellness Health and Research Facility (WHARF)
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Christine Ferguson, PhD
role: PRINCIPAL_INVESTIGATOR
References: