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NOT YET RECRUITING
NCT06216925
NA

Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

Sponsor: University of Mississippi Medical Center

View on ClinicalTrials.gov

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 ≥10,000 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.

Official title: Teen Mom Study: A Confirmatory Pragmatic Cluster Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

15 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-08-01

Completion Date

2026-06-30

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

#BabyLetsMove

Description of #BabyLetsMove

BEHAVIORAL

WIC Antenatal Care

Description