Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284681
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-02-06
Brief Title:
Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISE Health
Brief 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 ie weight loss and weight-neutral ie weight loss is not an explicit goal adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity BMI 27 kgm2 plus at least one weight-related cardiometabolic condition high blood pressure prediabetes or diabetes andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3P50MD017338-03S1 | NIH | None | httpsreporternihgovquickSearch3P50MD017338-03S1 |