NCT06284681

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Weight-focused health coaching	Following the definition of structured lifestyle interventions within the current obesity clinical practice guidelines, the weight-focused health coaching intervention will be delivered as a multi-component behavior change intervention intended to produce clinically-important weight loss through consuming a healthy, energy-restricted diet and increasing physical activity.
BEHAVIORAL	Weight-neutral health coaching	Dietary and physical activity prescriptions for the weight-neutral health coaching intervention will be similar to the weight-focused intervention except the diet prescription will be designed to fully meet daily estimated energy requirements rather than creating a negative energy balance and producing weight loss. Health coaches will not emphasize changes in body weight as an explicit goal or as a mediator of improved cardiometabolic health. Rather, health coaches will emphasize achieving diet and exercise behavioral goals as a direct means to improving cardiometabolic health independently of changes in body weight.
BEHAVIORAL	Intensify lifestyle approach	Participants identified as non-responders to initial health coaching interventions may be re-randomized to receive a 4-month membership to the local YMCA and health coaches will assist participants in identifying and enrolling in at least 2 weekly group fitness classes at the YMCA.
OTHER	Augment with enhanced medical management	Participants identified as non-responders to initial health coaching interventions may be re-randomized to meet with the primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2024-02-29
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States