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Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

Obesity Clinical Trial

Official title:
Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

Clinical Trial Summary

The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce improvements in insulin resistance. This study is a Sequential Multiple Assignment Randomized Trial (SMART) with initial randomization groups of individualized nutrition counseling vs. individualized exercise counseling. Note that these initial nutrition or exercise interventions are NOT intended to produce significant weight loss. Participants that do not sufficiently improve their insulin resistance score after 8 weeks will be re-randomized to 2nd stage interventions of either receiving dietary counseling for weight loss or receiving a prescription for metformin. We will collect data on the effectiveness of the intervention to improve insulin resistance/metabolic health in the family medicine clinic as well as potential predictors or moderators of treatment success.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04392284
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Completed
Phase N/A
Start date April 19, 2021
Completion date June 3, 2022
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