Life sciences · Interventional Study
ClinicalTrials.gov · October 27, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT04392284). This is a study registration, not published results. Lead sponsor: University of Alabama at Birmingham. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ACTUAL). Conditions: Insulin Resistance, Obesity, Diabetes, Hypertension, Dyslipidemias, Metabolic Syndrome. Interventions: BEHAVIORAL: Diet Counseling; BEHAVIORAL: Exercise Counseling. Primary outcome measures: Rates of recruitment and retention , Baseline; Rates of recruitment and retention , Month 2; Rates of recruitment and retention , 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 , Month 2; Number of counseling sessions attended , Month 6; Frequency of metformin adherence (as applicable) , Month 2; Frequency of metformin adherence (as applicable) , Month 6; Intervention preference , Baseline; Intervention preference , Month 2; Intervention preference , Month 6; Treatment credibility , Baseline; Treatment credibility , Month 2; Treatment credibility , Month 6. 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.