Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Rates of recruitment and retention [Baseline]
Number of participants recruited and retained in intervention
- Rates of recruitment and retention [Month 2]
Number of participants recruited and retained in intervention
- Rates of recruitment and retention [Month 6]
Number of participants recruited and retained in intervention
- 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 [Month 2]
Attendance to Zoom meetings
- Number of counseling sessions attended [Month 6]
Attendance to Zoom meetings
- Frequency of metformin adherence (as applicable) [Month 2]
Number of times metformin was taken as prescribed
- Frequency of metformin adherence (as applicable) [Month 6]
Number of times metformin was taken as prescribed
- Intervention preference [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.
- Intervention preference [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.
- Intervention preference [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.
- Treatment credibility [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.")
- Treatment credibility [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.")
- Treatment credibility [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 Outcome Measures
- Changes in body weight [Baseline to Months 2 and 6]
- Changes in body composition (fat and lean mass) [Baseline to Months 2 and 6]
Fat mass and lean mass via bioelectrical impedance analysis
- Changes in glucose [Baseline to Months 2 and 6]
Serum glucose will be measured in a fasted state
- Changes in insulin [Baseline to Months 2 and 6]
Serum insulin will be measured in a fasted state
- Changes in glycosylated hemoglobin (hemoglobin A1C) [Baseline to Months 2 and 6]
Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control
- Changes in lipids [Baseline to Months 2 and 6]
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female
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Any race or ethnicity
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BMI >27 kg/m2
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Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity)
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Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease
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Stable medication type and dosage for ≥3 months
Exclusion Criteria:
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If type 2 diabetes,
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Currently prescribed metformin or prescribed within previous 3 months
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HbA1c concentration of >12%
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Using exogenous insulin
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Pregnant or lactating within the past 6 months or trying to become pregnant
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Prescription for weight loss medications within the past 3 months
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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.
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History of kidney disease that may increase the risk of lactic acidosis with metformin.
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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).
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Does not have a life-sustaining medical implant such as a pacemaker.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB Highlands Family and Community Medicine Clinic | Birmingham | Alabama | United States | 35205 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300005391