Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

The University of Alabama at Birmingham

Status

Completed

Conditions

Hypertension

Diabetes

Dyslipidemias

Insulin Resistance

Obesity

Metabolic Syndrome

Treatments

Behavioral: Exercise Counseling

Behavioral: Diet Counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT04392284

IRB-300005391

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.