Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216925
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-01-11
Brief Title:
Teen Mom Study A Confirmatory Pragmatic Cluster RCT
Sponsor:
University of Mississippi Medical Center
Organization:
University of Mississippi Medical Center
Study Overview
Official Title:
Teen Mom Study A Confirmatory Pragmatic Cluster Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this clinical trial is to test the effectiveness of BabyLetsMove - a 24-week mobile Health and peer health coaching intervention paired with the Special Supplemental Nutrition Program for Women Infants and Children WIC - to increase physical activity and reduce sedentary behavior in pregnant Black teens in the Mississippi Delta The main questions it aims to answer are
Does BabyLetsMove increase objective moderate-to-vigorous physical activity and decrease sedentary behavior from 16 to 26- and 36-gestational weeks compared to usual WIC care alone
Does BabyLetsMove decrease the rate of gestational weight gain and mean arterial pressure from 16 to 26- and 36-gestational weeks compared to usual WIC care alone
Is BabyLetsMove a feasible and acceptable intervention according to the RE-AIM framework
Using the Practical Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research what are the barriers to organizational uptake and how can strategies be improved for future testing
Participants will be given three empirically supported behavior goals including 1 watching 2 hours of TV or other screen time per day and 2 walking 10000 steps per day - or - 3 engaging in 20 minutes of organized exercise per day
Researchers will compare the BabyLetsMove groups to the WIC care only groups to see if the BabyLetsMove intervention improves traditional WIC care for bettering health outcomes amongst pregnant Black teens in the Mississippi Delta
Does BabyLetsMove increase objective moderate-to-vigorous physical activity and decrease sedentary behavior from 16 to 26- and 36-gestational weeks compared to usual WIC care alone
Does BabyLetsMove decrease the rate of gestational weight gain and mean arterial pressure from 16 to 26- and 36-gestational weeks compared to usual WIC care alone
Is BabyLetsMove a feasible and acceptable intervention according to the RE-AIM framework
Using the Practical Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research what are the barriers to organizational uptake and how can strategies be improved for future testing
Participants will be given three empirically supported behavior goals including 1 watching 2 hours of TV or other screen time per day and 2 walking 10000 steps per day - or - 3 engaging in 20 minutes of organized exercise per day
Researchers will compare the BabyLetsMove groups to the WIC care only groups to see if the BabyLetsMove intervention improves traditional WIC care for bettering health outcomes amongst pregnant Black teens in the Mississippi Delta
Detailed Description:
The Teen Mom Study A Hybrid Cluster Randomized Trial proposes a pragmatic multilevel type I study design to test the effectiveness of BabyLetsMove - a 24-week mHealth and peer health coaching intervention paired with the Special Supplemental Nutrition Program for Women Infants and Children WIC - to increase physical activity and reduce sedentary behavior in pregnant Black teens in the Mississippi Delta Concurrently a robust implementation evaluation will be conducted to determine feasibility and acceptability and to identify threats to organizational uptake scalability and sustainability The intervention will be delivered remotely in partnership with WIC Mississippi State Department of Health the Telehealth Center of Excellence and Myrlie Evers-Williams Institute University of Mississippi Medical Center The intervention is based on formative data from the Teen Mom Study and uses a theory-based multi-level systems change approach At the systems level racially concordant young adult 18 to 25 years WIC moms n4 are undergoing paid skills training in evidence-based peer health coaching to first address social needs in pregnant teens and second provide support for self-directed behavior change At the individual level pregnant Black teens will be given three empirically supported behavior goals including 1 watching 2 hours of TV or other screen time per day and 2 walking 10000 steps per day - or - 3 engaging in 20 minutes of organized exercise per day The intervention is designed to build social cognition affect and skills using four intervention components - a wearable tracker interactive self-monitoring text messages with automated feedback tailored skills training texts linked to digital materials and peer health coaching The central hypothesis is that augmenting usual WIC care with BabyLetsMove will improve WICs capacity to serve rural families and empower pregnant Black teens to prioritize and improve their health The primary aim is to determine the effect of BabyLetsMove compared to usual WIC care on objective moderate-to-vigorous physical activity and sedentary behavior from 16 to 26- and 36-gestational weeks using a parallel cluster randomized trial Secondary aim 1 will use wearables plus remote monitoring to measure and explore patterns of gestational weight gain and mean arterial pressure withinacross conditions Secondary aim 2a will use the RE-AIM framework to evaluate the feasibility and acceptability of BabyLetsMove and Secondary aim 2b will use the Practical Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research to identify threats to organizational uptake and to develop implementation strategies for future testing This is believed to be the first digital health intervention study designed withfor a pregnant adolescent population This study will add to our understanding of optimal mHealth and peer health coaching interventions advance implementation science literature by studying a scalable and sustainable intervention in a novel setting and contribute to the urgent national agenda to advance Black maternal health equity
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 |
|---|---|---|---|
| P50MD017338 | NIH | None | httpsreporternihgovquickSearchP50MD017338 |