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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Counseling | Experimental | Delivery of nutrition counseling intervention to improve diet quality. |
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| Exercise Counseling | Experimental | Delivery of exercise counseling intervention to increase engagement in physical activity.. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Highlands Family and Community Medicine Clinic | Birmingham | Alabama | 35205 | United States |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Sequential Multiple Assignment Randomized Trial (SMART)
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|
| 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. |
|
| 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 |
| 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 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |