Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06976307

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionDisabilities, Obesity and Overweight, Prediabetes

Full registry 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)

Treatments and study arms

High Carbohydrate Diet

Behavioral

Participants randomized to this group will participate in a group-based weight behavioral management program and consume a high carbohydrate (HC) diet. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine HC diet with time-restricted eating (TRE) or HC diet with additional exercise counseling and support.

Reduced Carbohydrate Diet

Behavioral

Participants randomized to this group will participate in a group-based behavioral weight management program and consume a reduced carbohydrate (RC) diet. Because this is a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine RC diet with time-restricted eating (TRE) or RC diet with additional exercise counseling and support.

Primary outcomes

Change in glucoseBaseline & Week 16

Serum glucose will be measured in a fasted state.

Changes in body weightBaseline, Week4, and Week 16

Measured on validated digital scale

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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