Improving cardiometabolic health in Black adults with weight-inclusive strategies
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
This study is testing whether weight-focused or weight-neutral health coaching can help Black adults with overweight or obesity improve their heart and metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06284681 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility of a Sequential Multiple Assignment Randomized Trial (SMART) comparing weight-focused and weight-neutral biobehavioral interventions for enhancing cardiometabolic health in Black adults with overweight or obesity. Participants will be randomly assigned to receive either type of health coaching for 7 weeks, after which their responses will determine the next steps in their intervention. The study targets individuals with at least one weight-related cardiometabolic condition, such as hypertension or diabetes, and incorporates lifestyle changes alongside medical management. The goal is to evaluate which approach is more effective in improving health outcomes.
Who should consider this trial
Good fit: Ideal candidates are Black or African American adults aged 18 and older with a BMI of 27 kg/m2 or higher and at least one weight-related cardiometabolic condition.
Not a fit: Patients currently engaged in structured lifestyle-based or weight loss interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide tailored interventions that significantly improve cardiometabolic health in Black adults.
How similar studies have performed: Other studies have shown promise in using adaptive biobehavioral interventions for similar health outcomes, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Black or African American Race * ≥18 years * BMI ≥27 kg/m2 plus a diagnostic history of 1 or more of the following: * Prehypertension or hypertension * Prediabetes or type 2 diabetes * Dyslipidemia * Has a primary care provider who is willing to participate in enhanced medical management condition as needed * Access and ability to use a device with reliable internet connectivity * Able to converse and read English * Willingness to enroll in any possible intervention conditions * Willingness to engage in post-intervention focus group Exclusion Criteria: * Presence of any condition precluding engagement in the prescribed diet or exercise interventions * Currently engaged in a structured lifestyle-based or weight loss intervention
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Drew Sayer, PhD — University of Alabama at Birmingham
- Study coordinator: Drew Sayer, PhD
- Email: sayerd@uab.edu
- Phone: (205) 354-8950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.