protocolSection identificationModule nctId: NCT06284681, orgStudyIdInfo id: IRB-300012557, secondaryIdInfos id: 3P50MD017338-03S1, type: NIH, link: https://reporter.nih.gov/quickSearch/3P50MD017338-03S1, briefTitle: Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults, acronym: WISE Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit)., conditionsModule conditions: Obesity, conditions: Prehypertension, conditions: Hypertension, conditions: PreDiabetes, conditions: Type 2 Diabetes, conditions: Dyslipidemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Weight-focused health coaching, interventions name: Weight-neutral health coaching, interventions name: Intensify lifestyle approach, interventions name: Augment with enhanced medical management, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Response/Non-response rate to initial interventions, primaryOutcomes measure: Attendance to health coaching sessions, primaryOutcomes measure: Treatment Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Treatment Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Treatment Preference, primaryOutcomes measure: Treatment Preference, primaryOutcomes measure: Family medicine clinic capacity for research, primaryOutcomes measure: Study visit duration, primaryOutcomes measure: Time required for surveys completion, primaryOutcomes measure: Response to weight-focused health coaching, primaryOutcomes measure: Response to weight-neutral health coaching measurement, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in glucose, secondaryOutcomes measure: Change in insulin, secondaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in total cholesterol, secondaryOutcomes measure: Change in LDL-cholesterol, secondaryOutcomes measure: Change in HDL-cholesterol, secondaryOutcomes measure: Change in triglycerides, secondaryOutcomes measure: Change in Metabolic Syndrome Severity Score, otherOutcomes measure: Change in blood pressure, otherOutcomes measure: Change in glucose, otherOutcomes measure: Change in insulin, otherOutcomes measure: Change in HbA1c, otherOutcomes measure: Change in total cholesterol, otherOutcomes measure: Change in LDL-cholesterol, otherOutcomes measure: Change in HDL-cholesterol, otherOutcomes measure: Change in triglycerides, otherOutcomes measure: Change in body weight, otherOutcomes measure: Change in physical activity, otherOutcomes measure: Change in fat mass, otherOutcomes measure: Change in fat mass, otherOutcomes measure: Change in lean mass, otherOutcomes measure: Change in lean mass, otherOutcomes measure: Change in waist circumference, otherOutcomes measure: Change in waist circumference, otherOutcomes measure: Dietary intake measurement, otherOutcomes measure: Dietary intake measurement, otherOutcomes measure: Change in insulin sensitivity, otherOutcomes measure: Change in Metabolic Syndrome Severity Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False