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Completed

NCT Number: NCT04745572

Development of an Adaptive Treatment for Weight Loss in People With Prediabetes

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.

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Key information

Conditions

PreDiabetes Behavior Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms 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

UAB Highlands Family and Community Medicine Clinic

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: Yes

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
  • at risk for developing type 2 diabetes (prediabetes)

Exclusion criteria

  • Pregnant, planning to become pregnant, or breastfeeding
  • uncontrolled hypo or hyperthyroidism

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. Changes in body weight

    Time frame: week 16 visit

    Measured on digital scale at final visit.

Secondary outcomes

  1. Change in glucose

    Time frame: week 16 visit

    Serum glucose will be measured in a fasted state.

  2. Change in hemoglobin A1c

    Time frame: week 16 visit

    A1c is a measure of average glucose over the previous 3 months.

  3. Change in insulin

    Time frame: week 16 visit

    Serum insulin will be measured in a fasted state.

  4. Changes in QUICKI index

    Time frame: week 16 visit

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

Other outcomes

  1. Changes in fat mass

    Time frame: week 16 visit

    As measured by bioelectrical impedance analysis (BIA) on the InBody S10 body composition analyzer.

  2. Changes in lipids

    Time frame: week 16 visit

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

  3. Change in Blood Pressure

    Time frame: week 16 visit

    Measured with a clinical grade blood pressure cuff.

  4. Changes in body weight

    Time frame: week 4 visit

    Measured on digital scale in order to determine "responder" or "non-responder" status.

  5. Changes in aerobic fitness

    Time frame: week 16 visit

    As measured by the 3-minute step test.

  6. Changes in overall strength

    Time frame: week 16 visit

    As measured by hand grip dynamometry

  7. Diet Intake and Physical Activity Monitoring

    Time frame: week 16 visit

    7-day food logs and weekly physical activity logs

  8. Diet Intake and Physical Activity Monitoring

    Time frame: week 4 visit

    7-day food logs and weekly physical activity logs

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • General Mills

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2021
Registry last updated
Apr 27, 2025

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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