Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565104
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
The Sleep2BWell Cluster-Randomized Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion The Sleep2BWell Community-Based Cluster-Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Improving multiple domains of cardiometabolic health CMH through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities Sleep is critical for preserving CMH and is amenable to intervention in real-world settings Although sleep health in conjunction with other lifestyle behaviors can improve CMH through complementary or synergistic pathways most existing lifestyle change programs focus solely on diet and physical activity Sleep2BWell is a community-based cluster randomized trial aimed at evaluating the impact of incorporating a multidimensional sleep health intervention into the BWell4Life program an ongoing 4-week program for promoting CMH through healthy diet and physical activity delivered by peer health educators at faith-based organizations and community centers in underserved NYC neighborhoods The enhanced 6-week intervention Sleep2BWell will include the following additional components 1 two sleep health education and group coaching sessions 2 self-monitoring and motivational enhancement using a Fitbit and 3 addressing prevalent environmental barriers to healthy sleep in urban settings such as noise and light with a novel and timely extension to address indoor air pollution A total of 14 community sites will be randomized into the intervention Sleep2BWell or control BWell4Life group enrolling an average of 15 participants per site for an expected sample of 210 We will collect objective measures of sleep and physical activity throughout the study and assess diet and CMH outcomes at baseline 10 weeks primary endpoint and 24 weeks long-term follow-up to assess sustainability of the interventions effect We hypothesize that Sleep2BWell will enhance the effectiveness of BWell4Life leading to greater improvements in CMH including reduced blood pressure primary outcome improved health behaviors sleep diet physical activity and adiposity markers secondary outcomes as well as better glycemic control and inflammatory and allostatic load indicators exploratory outcomes To ensure the successful completion and future expansion of this work we will use mixed methods to understand implementation determinants and outcomes guided by implementation science frameworks This first-of-its-kind effectiveness-implementation study addressing individual level behaviors and factors and upstream influences and leveraging key behavior change and community engagement strategies will investigate the integration of sleep health into a multi-behavior lifestyle change intervention aimed at addressing CMH disparities in community settings Our innovative multilevel intervention will inform scalable sustainable community health approaches and public health policy to improve sleep health and CMH disparities through advancement in novel multilevel bundled behavioral interventions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None