Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

Not Applicable

Completed

Conditions: Insulin Resistance
Diabetes
Obesity
Hypertension
Dyslipidemias
Metabolic Syndrome

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Exercise Counseling	Exercise Counseling	Delivery of exercise counseling intervention to increase engagement in physical activity..
Diet Counseling	Diet Counseling	Delivery of nutrition counseling intervention to improve diet quality.

Primary Outcome Measures

Name	Time	Method
Family medicine clinician referral rates	Month 6
Number of counseling sessions attended	Month 6	Attendance to Zoom meetings
Frequency of metformin adherence (as applicable)	Month 6	Number of times metformin was taken as prescribed
Treatment credibility	Month 6	Assessment of participants' perception of treatment success using the Credibility/Expectancy Questionnaire with a 9-point Likert scale, ranging from "not at all" (1) to "very" (9) for several descriptors (e.g., "useful," "logical.")
Rates of recruitment and retention	Month 6	Number of participants recruited and retained in intervention
Intervention preference	Month 6	Preference is determined by the Intervention Preference Questionnaire, using a 5-point Likert Scale for preference among study treatment arms. Scale includes options for "strong," "slight," or "no" preference for a given treatment component.

Secondary Outcome Measures

Name	Time	Method
Changes in glucose	Baseline to Months 2 and 6	Serum glucose will be measured in a fasted state
Changes in body weight	Baseline to Months 2 and 6
Changes in glycosylated hemoglobin (hemoglobin A1C)	Baseline to Months 2 and 6	Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control
Changes in body composition (fat and lean mass)	Baseline to Months 2 and 6	Fat mass and lean mass via bioelectrical impedance analysis
Changes in insulin	Baseline to Months 2 and 6	Serum insulin will be measured in a fasted state
Changes in lipids	Baseline to Months 2 and 6	Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides

Locations (1): UAB Highlands Family and Community Medicine Clinic
🇺🇸
Birmingham, Alabama, United States