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Clinical Trials/NCT04745572
NCT04745572
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country90 target enrollmentMay 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
University of Alabama at Birmingham
Enrollment
90
Locations
1
Primary Endpoint
Changes in body weight
Status
Completed
Last Updated
last year

Overview

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 (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.

Registry
clinicaltrials.gov
Start Date
May 14, 2021
End Date
November 21, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Holly Wyatt

Professor

University of Alabama at Birmingham

Eligibility 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

Outcomes

Primary Outcomes

Changes in body weight

Time Frame: week 16 visit

Measured on digital scale at final visit.

Secondary Outcomes

  • Change in glucose(week 16 visit)
  • Change in hemoglobin A1c(week 16 visit)
  • Change in insulin(week 16 visit)
  • Changes in QUICKI index(week 16 visit)

Study Sites (1)

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