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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745572
• Other study ID #: IRB-300006816
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: November 21, 2023

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State
• Weight Loss

Intervention

Behavioral:
• High Carbohydrate Diet
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
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.

Locations

Country	Name	City	State
United States	UAB Highlands Family and Community Medicine Clinic	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	General Mills

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight	Measured on digital scale in order to determine "responder" or "non-responder" status.	week 4 visit
Primary	Changes in body weight	Measured on digital scale at final visit.	week 16 visit
Primary	Change in glucose	Serum glucose will be measured in a fasted state.	week 16 visit
Primary	Change in insulin	Serum insulin will be measured in a fasted state.	week 16 visit
Primary	Changes in lipids	Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol	week 16 visit
Primary	Changes in fat mass	As measured by bioelectrical impedance analysis (BIA) on the InBody S10 body composition analyzer.	week 16 visit
Primary	Changes in QUICKI index	Predictor of insulin resistance that will be calculated from glucose and insulin measures	week 16 visit
Secondary	Changes in overall strength	As measured by hand grip dynamometry	week 16 visit
Secondary	Changes in aerobic fitness	As measured by the 3-minute step test.	week 16 visit
Secondary	Diet Intake and Physical Activity Monitoring	7-day food logs and weekly physical activity logs	week 4 visit
Secondary	Diet Intake and Physical Activity Monitoring	7-day food logs and weekly physical activity logs	week 16 visit