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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
UAB Highlands Family and Community Medicine Clinic
Birmingham, Alabama, United States
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Time frame: Baseline
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Time frame: Month 2
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Time frame: Month 6
Family medicine clinician referral rates
Time frame: Baseline
Family medicine clinician referral rates
Time frame: Month 2
Family medicine clinician referral rates
Time frame: Month 6
Number of counseling sessions attended
Attendance to Zoom meetings
Time frame: Month 2
Number of counseling sessions attended
Attendance to Zoom meetings
Time frame: Month 6
Frequency of metformin adherence (as applicable)
Number of times metformin was taken as prescribed
Time frame: Month 2
Frequency of metformin adherence (as applicable)
Number of times metformin was taken as prescribed
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.")
Time frame: 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.")
Time frame: 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.")
Time frame: Month 6
Changes in body weight
Time frame: Baseline to Months 2 and 6
Changes in body composition (fat and lean mass)
Fat mass and lean mass via bioelectrical impedance analysis
Time frame: Baseline to Months 2 and 6
Changes in glucose
Serum glucose will be measured in a fasted state
Time frame: Baseline to Months 2 and 6
Changes in insulin
Serum insulin will be measured in a fasted state
Time frame: Baseline to Months 2 and 6
Changes in glycosylated hemoglobin (hemoglobin A1C)
Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control
Time frame: Baseline to Months 2 and 6
Changes in lipids
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Time frame: Baseline to Months 2 and 6
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