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

Study Overview
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Brief Summary
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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.

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

Conditions
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PreDiabetes, Obesity

Intervention / Treatment
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* Behavioral: High Carbohydrate Diet
* Behavioral: Reduced Carbohydrate Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Carbohydrate Diet<br>Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan. | Behavioral: High Carbohydrate Diet<br>* 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.<br>|
| Experimental: Reduced Carbohydrate Diet<br>Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan. | Behavioral: Reduced Carbohydrate Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight | Measured on digital scale in order to determine responder or non-responder status. | week 4 visit | 
| Changes in body weight | Measured on digital scale at final visit. | week 16 visit | 
| Change in glucose | Serum glucose will be measured in a fasted state. | week 16 visit | 
| Change in insulin | Serum insulin will be measured in a fasted state. | week 16 visit | 
| Changes in lipids | Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol | week 16 visit | 
| Changes in fat mass | As measured by bioelectrical impedance analysis (BIA) on the InBody S10 body composition analyzer. | week 16 visit | 
| Changes in QUICKI index | Predictor of insulin resistance that will be calculated from glucose and insulin measures | week 16 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in overall strength | As measured by hand grip dynamometry | week 16 visit | 
| Changes in aerobic fitness | As measured by the 3-minute step test. | week 16 visit | 
| Diet Intake and Physical Activity Monitoring | 7-day food logs and weekly physical activity logs | week 4 visit | 
| Diet Intake and Physical Activity Monitoring | 7-day food logs and weekly physical activity logs | week 16 visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, reduced carbohydrate diet, exercise training, time restricted eating