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Completed

NCT Number: NCT04392284

Developing 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.

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Key information

Conditions

Insulin Resistance Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Highlands Family and Community Medicine Clinic

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Rates of recruitment and retention

    Time frame: Baseline

    Number of participants recruited and retained in intervention

  2. Rates of recruitment and retention

    Time frame: Month 2

    Number of participants recruited and retained in intervention

  3. Rates of recruitment and retention

    Time frame: Month 6

    Number of participants recruited and retained in intervention

  4. Family medicine clinician referral rates

    Time frame: Baseline

  5. Family medicine clinician referral rates

    Time frame: Month 2

  6. Family medicine clinician referral rates

    Time frame: Month 6

  7. Number of counseling sessions attended

    Time frame: Month 2

    Attendance to Zoom meetings

  8. Number of counseling sessions attended

    Time frame: Month 6

    Attendance to Zoom meetings

  9. Frequency of metformin adherence (as applicable)

    Time frame: Month 2

    Number of times metformin was taken as prescribed

  10. Frequency of metformin adherence (as applicable)

    Time frame: Month 6

    Number of times metformin was taken as prescribed

  11. Intervention preference

    Time frame: Baseline

    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.

  12. Intervention preference

    Time frame: Month 2

    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.

  13. Intervention preference

    Time frame: 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.

  14. Treatment credibility

    Time frame: Baseline

    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.")

  15. Treatment credibility

    Time frame: Month 2

    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.")

  16. Treatment credibility

    Time frame: 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.")

Secondary outcomes

  1. Changes in body weight

    Time frame: Baseline to Months 2 and 6

  2. Changes in body composition (fat and lean mass)

    Time frame: Baseline to Months 2 and 6

    Fat mass and lean mass via bioelectrical impedance analysis

  3. Changes in glucose

    Time frame: Baseline to Months 2 and 6

    Serum glucose will be measured in a fasted state

  4. Changes in insulin

    Time frame: Baseline to Months 2 and 6

    Serum insulin will be measured in a fasted state

  5. Changes in glycosylated hemoglobin (hemoglobin A1C)

    Time frame: Baseline to Months 2 and 6

    Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control

  6. Changes in lipids

    Time frame: Baseline to Months 2 and 6

    Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 18, 2020
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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