Clinical Trial

Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

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Record status
This record was last updated April 27, 2025 (before its estimated December 19, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-01-11; most recent amendment 2025-04-23.
Trial Details
NCT Number NCT06216925
Lead Sponsor University of Mississippi Medical Center
Collaborators: University of Alabama at Birmingham, National Institute on Minority Health and Health Disparities (NIMHD)
Conditions Sedentary Behavior, Physical Activity, Gestational Weight Gain, Arterial Pressure
Enrollment 144 participants
Start Date 2025-08-01
Primary Completion 2025-12-19 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-27