Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in glucose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
High Carbohydrate Diet
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.
Intervention: High Carbohydrate Diet (Behavioral)
Reduced Carbohydrate Diet
Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.
Intervention: Reduced Carbohydrate Diet (Behavioral)
Outcomes
Primary Outcomes
Change in glucose
Time Frame: Baseline & Week 16
Serum glucose will be measured in a fasted state.
Changes in body weight
Time Frame: Baseline, Week4, and Week 16
Measured on validated digital scale
Secondary Outcomes
- Changes in fat mass(Baseline & Week 16)
- Change in insulin(Baseline & Week 16)
- Changes in lipids(Baseline & Week 16)
- Changes in QUICKI index(Baseline & Week 16)
- Changes in overall strength(Baseline & Week 16)
- Changes in aerobic fitness(Baseline & Week 16)
Investigators
Christine Ferguson, PhD, RD, LD
Assistant Professor
University of Alabama at Birmingham