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NCT06284681 · ClinicalTrials.gov registry record · NA
Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT06284681 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 41 participants.
The verdict
NCT06284681, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study 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 condition
Interventions
- BEHAVIORAL Weight-focused health coaching
- BEHAVIORAL Weight-neutral health coaching
- BEHAVIORAL Intensify lifestyle approach
- OTHER Augment with enhanced medical management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06284681
The ClinicalTrials.gov registry entry for NCT06284681 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Weight-focused health coaching is the first listed.
NCT06284681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06284681 about?
NCT06284681 is a clinical study titled "Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults". 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) adap...
What is the current status of trial NCT06284681?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2024-10-01. Estimated completion is 2026-01-31.
What interventions are being tested in trial NCT06284681?
The interventions under investigation include: Weight-focused health coaching (BEHAVIORAL), Weight-neutral health coaching (BEHAVIORAL), Intensify lifestyle approach (BEHAVIORAL), Augment with enhanced medical management (OTHER).
Who is sponsoring clinical trial NCT06284681?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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