Dietary Strategies for Prediabetes

(iADAPT Trial)

Overseen By Omer Faruq, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Diabetes, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christine Ferguson, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for people with prediabetes, obesity, or related conditions who haven't had success with traditional weight loss methods. It's also open to those with disabilities. Participants should be at risk for type 2 diabetes and willing to follow a high or reduced carbohydrate diet.

Inclusion Criteria

My BMI is over 27, or over 22 if I have a spinal cord injury.

I am at risk for type 2 diabetes.

Willing to complete requirements for participation

Exclusion Criteria

Pregnant, planning to become pregnant or breastfeeding

I am currently on medication 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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to consume either a high or reduced carbohydrate diet

4 weeks

Baseline visit, Week 4 assessment

Adaptive Treatment

Responders continue with initial diet; Non-responders are re-randomized to additional interventions

12 weeks

Week 16 assessment

Follow-up

Participants are monitored for changes in glucose, body weight, and other health metrics

4 weeks

Treatment Details

Interventions

• High Carbohydrate Diet
• Reduced Carbohydrate Diet

Trial Overview The study tests whether a high or reduced carbohydrate diet can help with weight loss in prediabetic individuals. After initial results, non-responders will get extra interventions like exercise counseling or time-restricted eating to see if these improve outcomes.

Participant Groups

Group I: Reduced Carbohydrate Diet Experimental Treatment 1 Intervention

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.

Group II: High Carbohydrate Diet Experimental Treatment 1 Intervention

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+