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

The University of Alabama at Birmingham

Status: Completed

Conditions: Obesity; PreDiabetes

Treatments: Behavioral: High Carbohydrate Diet; Behavioral: Reduced Carbohydrate Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04745572

IRB-300006816

General Mills (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

High Carbohydrate Diet

Experimental group

Description:

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.

Treatment:

Behavioral: High Carbohydrate Diet

Reduced Carbohydrate Diet

Experimental group

Description:

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.

Treatment:

Behavioral: Reduced Carbohydrate Diet