Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

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.

Conditions

• Sedentary Behavior
• Physical Activity
• Gestational Weight Gain
• Arterial Pressure

Interventions

BEHAVIORAL

#BabyLetsMove

Description of #BabyLetsMove

BEHAVIORAL

WIC Antenatal Care

Description

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of Mississippi Medical Center

  lead OTHER

Principal Investigators

• Abigail Gamble, PhD · University of Mississippi Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

19 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2025-12-19

Completion

2026-06-30