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Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

StatusNot Yet Recruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Notable Primary completion date: Jan 30, 2027 to Dec 19, 2025
    • Study completion date: Feb 28, 2027 to Jun 30, 2026
    v7
  2. Notable Primary completion date: May 30, 2026 to Jan 30, 2027
    • Start date: Oct 1, 2024 to Aug 1, 2025
    • Study completion date: Jun 5, 2026 to Feb 28, 2027
    v6
  3. Notable Start date: Aug 1, 2024 to Oct 1, 2024v5
  4. Notable Start date: Jul 1, 2024 to Aug 1, 2024v4
  5. Notable Start date: May 1, 2024 to Jul 1, 2024
    • Primary completion date: Mar 31, 2026 to May 30, 2026
    • Study completion date: Mar 31, 2026 to Jun 5, 2026
    v3
  6. Notable Start date: Mar 1, 2024 to May 1, 2024
    • Study title expanded, about 1 word
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)
Sedentary Behavior, Physical Activity, Gestational Weight Gain, Arterial Pressure
Related terms Gestational Weight Gain, Motor Activity, Sedentary Behavior
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov