Clinical trial NCT04392284: Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Official title: Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Diabetes
Hypertension
Dyslipidemias
Metabolic Syndrome
Keywords: insulin resistance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
Primary purpose: TREATMENT

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.


Eligibility 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 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.

Primary outcomes:
measure: Rates of recruitment and retention
timeFrame: Baseline
measure: Rates of recruitment and retention
timeFrame: Month 2
measure: Rates of recruitment and retention
timeFrame: Month 6
measure: Family medicine clinician referral rates
timeFrame: Baseline
measure: Family medicine clinician referral rates
timeFrame: Month 2
measure: Family medicine clinician referral rates
timeFrame: Month 6
measure: Number of counseling sessions attended
timeFrame: Month 2
measure: Number of counseling sessions attended
timeFrame: Month 6
measure: Frequency of metformin adherence (as applicable)
timeFrame: Month 2
measure: Frequency of metformin adherence (as applicable)
timeFrame: Month 6
measure: Intervention preference
timeFrame: Baseline
measure: Intervention preference
timeFrame: Month 2
measure: Intervention preference
timeFrame: Month 6
measure: Treatment credibility
timeFrame: Baseline
measure: Treatment credibility
timeFrame: Month 2
measure: Treatment credibility
timeFrame: Month 6
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline to Months 2 and 6
measure: Changes in body composition (fat and lean mass)
timeFrame: Baseline to Months 2 and 6
measure: Changes in glucose
timeFrame: Baseline to Months 2 and 6
measure: Changes in insulin
timeFrame: Baseline to Months 2 and 6
measure: Changes in glycosylated hemoglobin (hemoglobin A1C)
timeFrame: Baseline to Months 2 and 6
measure: Changes in lipids
timeFrame: Baseline to Months 2 and 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Highlands Family and Community Medicine Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Drew Sayer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Tapan Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Gareth Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References: