Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

NCT ID: NCT06216925

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-06-30

Brief 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.

Detailed Description

The "Teen Mom Study: A Hybrid Cluster Randomized Trial" proposes a pragmatic, multilevel, type I study design to test the effectiveness of #BabyLetsMove - a 24-week mHealth 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. Concurrently, a robust implementation evaluation will be conducted to determine feasibility and acceptability and to identify threats to organizational uptake, scalability, and sustainability. The intervention will be delivered remotely in partnership with WIC (Mississippi State Department of Health), the Telehealth Center of Excellence, and Myrlie Evers-Williams Institute (University of Mississippi Medical Center). The intervention is based on formative data from the "Teen Mom Study" and uses a theory-based, multi-level systems change approach. At the systems level, racially concordant young adult (18 to 25 years) WIC moms (n=4) are undergoing paid skills training in evidence-based peer health coaching to first, address social needs in pregnant teens and second, provide support for self-directed behavior change. At the individual level, pregnant, Black teens 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. The intervention is designed to build social cognition, affect, and skills using four intervention components - a wearable tracker, interactive self-monitoring text messages with automated feedback, tailored skills training texts linked to digital materials, and peer health coaching. The central hypothesis is that augmenting usual WIC care with #BabyLetsMove will improve WIC's capacity to serve rural families and empower pregnant, Black teens to prioritize and improve their health. The primary aim is to determine the effect of #BabyLetsMove compared to usual WIC care on objective moderate-to-vigorous physical activity and sedentary behavior from ≤16 to 26- and 36-gestational weeks using a parallel cluster randomized trial. Secondary aim 1 will use wearables plus remote monitoring to measure and explore patterns of gestational weight gain and mean arterial pressure within/across conditions. Secondary aim 2.a. will use the RE-AIM framework to evaluate the feasibility and acceptability of #BabyLetsMove, and Secondary aim 2.b. will use the Practical, Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research to identify threats to organizational uptake and to develop implementation strategies for future testing. This is believed to be the first digital health intervention study designed with/for a pregnant adolescent population. This study will add to our understanding of optimal mHealth and peer health coaching interventions; advance implementation science literature by studying a scalable and sustainable intervention in a novel setting; and contribute to the urgent national agenda to advance Black maternal health equity.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

#BabyLetsMove

For 24 weeks, participants will wear a Fitbit activity tracker (continually) and receive interactive self-monitoring and tailored feedback text messages (twice per week), tailored skills training texts and materials (once per week), and peer health coaching (once every other week). In addition, the participants will receive ancillary healthy food to allay food insecurity, nutritional counseling, and clinical care referrals once every three months.

Group Type: EXPERIMENTAL

#BabyLetsMove

Intervention Type: BEHAVIORAL

Description of #BabyLetsMove

WIC Antenatal Care

The participants will receive ancillary healthy food to allay food insecurity, nutritional counseling, and clinical care referrals once every three months.

Group Type: ACTIVE_COMPARATOR

WIC Antenatal Care

Intervention Type: BEHAVIORAL

Description

Interventions

#BabyLetsMove

Description of #BabyLetsMove

Intervention Type: BEHAVIORAL

WIC Antenatal Care

Description

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Less than 16 weeks pregnant
• Black or African-American
• Between 15 and 19 years of age (inclusive)
• Enrolled in WIC
• Residing in 1 of 12 counties constituting the Mississippi Delta region
• Singleton pregnancy
• Planning to carry the fetus to term
• English speaking
• Possession of a mobile device

Exclusion Criteria

• Individuals with physical activity restrictions

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Abigail Gamble

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abigail Gamble, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Central Contacts

Abigail Gamble, PhD

Role: CONTACT

agamble2@umc.edu

601-815-9482

Rolanda Buck, MS

Role: CONTACT

rbuck@umc.edu

601-815-9003

Other Identifiers

P50MD017338

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-409

Identifier Type: -

Identifier Source: org_study_id