Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Diabetes; Metabolic Syndrome; Insulin Resistance; Dyslipidemias
• Intervention / Treatment: Behavioral: Diet Counseling; Behavioral: Exercise Counseling

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Highlands Family and Community Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diet Counseling; Delivery of nutrition counseling intervention to improve diet quality.	Behavioral: Diet Counseling; Delivery of nutrition counseling intervention to improve diet quality. Suggested energy intake will be prescribed with the intent to maintain energy balance and current body weight. A total of 16 nutrition counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). "Responding" participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of nutrition counseling through the end of the study, meeting with the dietitian every other week. Starting at week 9, those identified as "non-responding" participants will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin.
EXPERIMENTAL: Exercise Counseling; Delivery of exercise counseling intervention to increase engagement in physical activity..	Behavioral: Exercise Counseling; Delivery of exercise counseling intervention to increase engagement in physical activity. The exercise specialist will counsel participants to progressively increase their weekly physical activity. Weight loss is not a primary goal of these exercise counseling sessions. A total of 16 exercise counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). "Responding" participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of exercise counseling through the end of the study, meeting with the exercise specialist every other week. Starting at week 9, those identified as "non-responders" will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of recruitment and retention	Number of participants recruited and retained in intervention	Baseline
Rates of recruitment and retention	Number of participants recruited and retained in intervention	Month 2
Rates of recruitment and retention	Number of participants recruited and retained in intervention	Month 6
Family medicine clinician referral rates		Baseline
Family medicine clinician referral rates		Month 2
Family medicine clinician referral rates		Month 6
Number of counseling sessions attended	Attendance to Zoom meetings	Month 2
Number of counseling sessions attended	Attendance to Zoom meetings	Month 6
Frequency of metformin adherence (as applicable)	Number of times metformin was taken as prescribed	Month 2
Frequency of metformin adherence (as applicable)	Number of times metformin was taken as prescribed	Month 6
Intervention preference	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.	Baseline
Intervention preference	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.	Month 2
Intervention preference	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.	Month 6
Treatment credibility	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.")	Baseline
Treatment credibility	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.")	Month 2
Treatment credibility	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.")	Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2021
• Primary Completion (ACTUAL): June 3, 2022
• Study Completion (ACTUAL): June 3, 2022

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (ACTUAL): May 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: insulin resistance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Lipid Metabolism Disorders; Metabolic Syndrome; Dyslipidemias; Insulin Resistance
• Other Study ID Numbers: IRB-300005391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No