Clinical trial NCT06216925: Teen Mom Study: A Confirmatory Pragmatic Cluster RCT
Official title: Teen Mom Study: A Confirmatory Pragmatic Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Physical Activity
Gestational Weight Gain
Arterial Pressure
Keywords: Pregnancy
Adolescent
Mobile Health
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-01-22
Enrollment: 144
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Moderate-to-Vigorous Physical Activity at 26 Weeks Gestation
timeFrame: Baseline to 26 weeks gestation
measure: Change in Moderate-to-Vigorous Physical Activity at 36 Weeks Gestation
timeFrame: Baseline to 36 weeks gestation
measure: Change in Sedentary Behavior at 26 Weeks Gestation
timeFrame: Baseline to 26 weeks gestation
measure: Change in Sedentary Behavior at 36 Weeks Gestation
timeFrame: Baseline to 36 weeks gestation
Secondary outcomes:
measure: Change in Gestational Weight Gain at 26 Weeks Gestation
timeFrame: Baseline to 26 weeks gestation
measure: Change in Gestational Weight Gain at 36 Weeks Gestation
timeFrame: Baseline to 36 weeks gestation
measure: Change in Mean Arterial Pressure at 26 Weeks Gestation
timeFrame: Baseline to 26 Weeks Gestation
measure: Change in Mean Arterial Pressure at 36 Weeks Gestation
timeFrame: Baseline to 36 Weeks Gestation
Other outcomes:
Locations:
Study officials:
affiliation: University of Mississippi Medical Center
name: Abigail Gamble, PhD
role: PRINCIPAL_INVESTIGATOR
References: