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

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ClinicalTrials.gov Identifier: NCT04745572
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : June 21, 2021
Sponsor:
Collaborator:
General Mills
Information provided by (Responsible Party):
Drew Sayer, University of Alabama at Birmingham

Study Description
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Brief Summary:
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 (6% weight loss) or Non-Responders (<6% 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.

Condition or disease Intervention/treatment Phase
PreDiabetes Obesity Behavioral: High Carbohydrate Diet Behavioral: Reduced Carbohydrate Diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of an Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial
Actual Study Start Date : May 14, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High Carbohydrate Diet
Enrollment in State of Slim (SOS) weight loss program with high carbohydrate diet plan.
 Behavioral: High Carbohydrate Diet
Participants randomized to this group will participate in the State of Slim (SOS) weight 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 structured exercise counseling sessions (2 days per week).
Experimental: Reduced Carbohydrate Diet
Enrollment in State of Slim (SOS) weight loss program with reduced carbohydrate diet plan.
 Behavioral: Reduced Carbohydrate Diet
Participants randomized to this group will participate in the State of Slim (SOS) 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 structured exercise counseling sessions (2 days per week).


Outcome Measures
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Primary Outcome Measures :
  1. Changes in body weight [ Time Frame: week 4 visit ]
    Measured on digital scale in order to determine "responder" or "non-responder" status.

  2. Changes in body weight [ Time Frame: week 16 visit ]
    Measured on digital scale at final visit.

  3. Change in glucose [ Time Frame: week 16 visit ]
    Serum glucose will be measured in a fasted state.

  4. Change in insulin [ Time Frame: week 16 visit ]
    Serum insulin will be measured in a fasted state.

  5. Changes in lipids [ Time Frame: week 16 visit ]
    Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol

  6. Changes in fat mass [ Time Frame: week 16 visit ]
    As measured by bioelectrical impedance analysis (BIA) on the InBody S10 body composition analyzer.

  7. Changes in QUICKI index [ Time Frame: week 16 visit ]
    Predictor of insulin resistance that will be calculated from glucose and insulin measures


Secondary Outcome Measures :
  1. Changes in overall strength [ Time Frame: week 16 visit ]
    As measured by hand grip dynamometry

  2. Changes in aerobic fitness [ Time Frame: week 16 visit ]
    As measured by the 6-minute walk test.

  3. Diet Intake and Physical Activity Monitoring [ Time Frame: week 4 visit ]
    7-day State of Slim (SOS) food logs and weekly physical activity logs

  4. Diet Intake and Physical Activity Monitoring [ Time Frame: week 16 visit ]
    7-day State of Slim (SOS) food logs and weekly physical activity logs


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745572


Contacts
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Contact: Chelsi Reynolds, MS 205-600-8023 cnreynolds@uabmc.edu
Contact: Drew Sayer, PhD sayerd@uab.edu

Locations
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United States, Alabama
UAB Highlands Family and Community Medicine Clinic Recruiting
Birmingham, Alabama, United States, 35205
Contact: Chelsi Reynolds, MS    205-600-8023    creynol3@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
General Mills
Investigators
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Principal Investigator: Drew Sayer, PhD University of Alabama at Birmingham
More Information
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Responsible Party: Drew Sayer, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04745572    
Other Study ID Numbers: IRB-300006816
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Drew Sayer, University of Alabama at Birmingham:
weight loss
reduced carbohydrate diet
exercise training
time restricted eating
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Weight Loss
Body Weight Changes
Body Weight
 Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia