Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

Study Overview
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Brief Summary
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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.

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

Conditions
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Insulin Resistance, Obesity, Diabetes, Hypertension, Dyslipidemias, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Diet Counseling
* Behavioral: Exercise Counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential Multiple Assignment Randomized Trial (SMART)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Counseling<br>Delivery of nutrition counseling intervention to improve diet quality. | Behavioral: Diet Counseling<br>* 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.<br>|
| Experimental: Exercise Counseling<br>Delivery of exercise counseling intervention to increase engagement in physical activity.. | Behavioral: Exercise Counseling<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin resistance