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Active, Not Recruiting

NCT Number: NCT06976307

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Disabilities Behavior Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellness Health and Research Facility (WHARF)

Birmingham, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. Change in glucose

    Time frame: Baseline & Week 16

    Serum glucose will be measured in a fasted state.

  2. Changes in body weight

    Time frame: Baseline, Week4, and Week 16

    Measured on validated digital scale

Secondary outcomes

  1. Changes in fat mass

    Time frame: Baseline & Week 16

    As measured by dual-energy X-ray absorptiometry (DEXA)

  2. Change in insulin

    Time frame: Baseline & Week 16

    Serum insulin will be measured in a fasted state.

  3. Changes in lipids

    Time frame: Baseline & Week 16

    Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol

  4. Changes in QUICKI index

    Time frame: Baseline & Week 16

    Predictor of insulin resistance that will be calculated from glucose and insulin measures

  5. Changes in overall strength

    Time frame: Baseline & Week 16

    As measured by hand grip dynamometry

  6. Changes in aerobic fitness

    Time frame: Baseline & Week 16

    As measured by graded exercise test using arm crank

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: iADAPT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 16, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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