Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

NCT04392284 | Completed

• 1 other identifier: IRB-300005391
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Obesity; Diabetes; Hypertension; Dyslipidemias; Metabolic Syndrome

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (6)

• Changes in body weight

  Baseline to Months 2 and 6

• Changes in body composition (fat and lean mass)

  Baseline to Months 2 and 6

• Changes in glucose

  Baseline to Months 2 and 6

• Changes in insulin

  Baseline to Months 2 and 6

• Changes in glycosylated hemoglobin (hemoglobin A1C)

  Baseline to Months 2 and 6

Study Arms (2)

Diet Counseling

EXPERIMENTAL

Delivery of nutrition counseling intervention to improve diet quality.

Behavioral: Diet Counseling

Exercise Counseling

EXPERIMENTAL

Delivery of exercise counseling intervention to increase engagement in physical activity..

Behavioral: Exercise Counseling

Interventions

Diet Counseling BEHAVIORAL

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.

Diet Counseling

Exercise Counseling BEHAVIORAL

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.

Exercise Counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Stable medication type and dosage for ≥3 months
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Highlands Family and Community Medicine Clinic

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Diabetes Mellitus; Hypertension; Dyslipidemias; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Officials

• Drew Sayer, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Tapan Mehta, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Gareth Dutton, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Sequential Multiple Assignment Randomized Trial (SMART)

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: May 18, 2020
• Study Start: April 19, 2021
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)