Developing an Obesity Treatment Program in Family Medicine Clinics

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 56
• Participant gender: All

Summary

The purpose of this study is to investigate the feasibility of conducting a multicomponent obesity treatment research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the intervention components. The research project will follow the Multiphase Optimization Strategy (MOST) framework to refine and screen intervention components for inclusion in a multicomponent obesity treatment program that could be delivered in family medicine clinics. The components to be investigated in the current study are 1) delivery type, 2) referral and membership at local YMCA, and 3) prescription of metformin . This study will use a 2x2x2 factorial design to investigate the main effects of each component in accordance with guidelines for using the MOST framework in clinical trials.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Male or female

• Any race or ethnicity

• BMI >27 kg/m2

• Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity) Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease

• Stable medication type and dosage for ≥3 months

Exclusion Criteria:

• If type 2 diabetes, Currently prescribed metformin HbA1c concentration of >12% Using exogenous insulin

• Pregnant or lactating within the past 6 months or trying to become pregnant

• Prescription for weight loss medications within the past 6 months

• Severe obesity-related complications that require immediate and more intensive clinical therapy (e.g., pharmacotherapy and/or bariatric surgery) as determined by study physician and/or referring practitioner at UAB Family Medicine Clinic.

• History of kidney disease that may increase the risk of lactic acidosis with metformin.

• Currently prescribed the following medications that may increase the risk of lactic acidosis with metformin: acetazolamide (Diamox), dichlorphenamide (Keveyis), methazolamide, topiramate (Topamax, in Qsymia), or zonisamide (Zonegran).