nctId: NCT06284681 id: IRB-300012557 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-29 date: 2024-03-21 name: University of Alabama at Birmingham class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) 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). conditions: Obesity conditions: Prehypertension conditions: Hypertension conditions: PreDiabetes conditions: Type 2 Diabetes conditions: Dyslipidemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Weight-focused health coaching name: Weight-neutral health coaching name: Intensify lifestyle approach name: Augment with enhanced medical management measure: Recruitment rate measure: Retention rate measure: Response/Non-response rate to initial interventions measure: Attendance to health coaching sessions measure: Treatment Credibility and Expectancy Questionnaire (CEQ) measure: Treatment Credibility and Expectancy Questionnaire (CEQ) measure: Treatment Preference measure: Treatment Preference measure: Family medicine clinic capacity for research measure: Study visit duration measure: Time required for surveys completion measure: Response to weight-focused health coaching measure: Response to weight-neutral health coaching measurement measure: Change in blood pressure measure: Change in glucose measure: Change in insulin measure: Change in insulin sensitivity measure: Change in HbA1c measure: Change in total cholesterol measure: Change in LDL-cholesterol measure: Change in HDL-cholesterol measure: Change in triglycerides measure: Change in Metabolic Syndrome Severity Score measure: Change in blood pressure measure: Change in glucose measure: Change in insulin measure: Change in HbA1c measure: Change in total cholesterol measure: Change in LDL-cholesterol measure: Change in HDL-cholesterol measure: Change in triglycerides measure: Change in body weight measure: Change in physical activity measure: Change in fat mass measure: Change in fat mass measure: Change in lean mass measure: Change in lean mass measure: Change in waist circumference measure: Change in waist circumference measure: Dietary intake measurement measure: Dietary intake measurement measure: Change in insulin sensitivity measure: Change in Metabolic Syndrome Severity Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False