Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Purpose
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.
Conditions
- Insulin Resistance
- Obesity
- Diabetes
- Hypertension
- Dyslipidemias
- Metabolic Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 or prescribed within previous 3 months - 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 3 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). - Does not have a life-sustaining medical implant such as a pacemaker.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Diet Counseling |
Delivery of nutrition counseling intervention to improve diet quality. |
|
Experimental Exercise Counseling |
Delivery of exercise counseling intervention to increase engagement in physical activity.. |
|
More Details
- Status
- Completed
- Sponsor
- University of Alabama at Birmingham