{ "data": { "asOf": "2026-10-30T22:26:14.886Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT04392284", "title": "Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics", "scientificTitle": "Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics", "status": "completed", "studyType": "interventional", "phase": [], "conditions": [ "Insulin Resistance", "Obesity", "Diabetes", "Hypertension", "Dyslipidemias", "Metabolic Syndrome" ], "interventions": [ { "name": "Diet Counseling", "type": "BEHAVIORAL", "description": "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." }, { "name": "Exercise Counseling", "type": "BEHAVIORAL", "description": "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." } ], "sponsor": { "name": "University of Alabama at Birmingham", "type": "OTHER" }, "locations": [ { "city": "Birmingham", "country": "United States", "facility": "UAB Highlands Family and Community Medicine Clinic" } ], "outcomes": { "other": [], "primary": [ "Rates of recruitment and retention", "Rates of recruitment and retention", "Rates of recruitment and retention", "Family medicine clinician referral rates", "Family medicine clinician referral rates", "Family medicine clinician referral rates", "Number of counseling sessions attended", "Number of counseling sessions attended", "Frequency of metformin adherence (as applicable)", "Frequency of metformin adherence (as applicable)", "Intervention preference", "Intervention preference", "Intervention preference", "Treatment credibility", "Treatment credibility", "Treatment credibility" ], "secondary": [ "Changes in body weight", "Changes in body composition (fat and lean mass)", "Changes in glucose", "Changes in insulin", "Changes in glycosylated hemoglobin (hemoglobin A1C)", "Changes in lipids" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Male or female\n* Any race or ethnicity\n* BMI \\>27 kg/m2\n* Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity)\n* Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease\n* Stable medication type and dosage for ≥3 months\n\nExclusion Criteria:\n\n* If type 2 diabetes,\n* Currently prescribed metformin or prescribed within previous 3 months\n* HbA1c concentration of \\>12%\n* Using exogenous insulin\n* Pregnant or lactating within the past 6 months or trying to become pregnant\n* Prescription for weight loss medications within the past 3 months\n* 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.\n* History of kidney disease that may increase the risk of lactic acidosis with metformin.\n* 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).\n* Does not have a life-sustaining medical implant such as a pacemaker.", "maximumAge": "75 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ACTUAL", "count": 40 }, "startDate": "2021-04-19", "completionDate": "2022-06-03", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2020-05-18T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT04392284" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT04392284", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT04392284", "sourceUrl": "https://clinicaltrials.gov/study/NCT04392284", "sourceStatus": "COMPLETED", "retrievedAt": "2026-10-28T04:32:38.869Z", "payloadSha256": "7a041180d421dbfe8ce4627b1c76d2ee1243b1b0cf144aa0563dc99077ed5714", "piiRedacted": true } ], "citation": { "canonicalId": "NCT04392284", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT04392284", "verifyAt": "https://clinicaltrials.gov/study/NCT04392284", "retrievedAt": "2026-10-28T04:32:38.869Z", "payloadSha256": "7a041180d421dbfe8ce4627b1c76d2ee1243b1b0cf144aa0563dc99077ed5714", "text": "ClinicalTrials.gov, record NCT04392284 (https://clinicaltrials.gov/study/NCT04392284), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT04392284, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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