Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-19
SponsorUniversity of Mississippi Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Less than 16 weeks pregnant

Black or African-American

Between 15 and 19 years of age (inclusive)

Enrolled in WIC

Disqualifiers

Individuals with physical activity restrictions

Trial design

Treatments tested in this trial

  • #BabyLetsMove
  • WIC Antenatal Care

Treatment groups

144 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Mississippi Medical Center

Lead sponsor

University of Alabama at Birmingham

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator