Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults — WISE Health  

Obesity Clinical Trial

Official title: Weight-focused vs. Weight-neutral Adaptive Biobehavioral Strategies for Improving Metabolic Health in Black Adults With Stage 1 Obesity: A Pilot Sequential Multiple Assignment Randomized Trial

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension
• Obesity
• PreDiabetes
• Prehypertension
• Type 2 Diabetes

• NCT number: NCT06284681
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Contact: Drew Sayer, PhD
• Phone: (205) 354-8950
• Email: sayerd@uab.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Completion date: December 31, 2025