NCT05843903

Teen Mom Study Feasibility Trial

Teen Mom Study Feasibility Trial: A Multicomponent Digital Health Intervention to Improve Cardiometabolic Health in Pregnant Black Adolescents

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: Female
• Age: 15 Years – 19 Years
• Healthy volunteers: Accepted

Summary

The proposed multicomponent digital health intervention has the potential to significantly impact the trajectory of maternal health in a rural, pregnant, Black adolescent population with the highest risks for cardiometabolic diseases worldwide. The proposed implementation strategy leverages mobile technologies which are ubiquitous across the socioeconomic gradient and proposes to train young adult WIC moms to deliver peer health coaching in a telehealth setting to address social barriers and support behavior change in pregnant, Black adolescent WIC clients in the Mississippi Delta - a rural region where the population is more than two-thirds percent Black and the teen birth rate is the highest in the United States. This is a scalable and sustainable approach to enhance WIC services and improve WIC's impact on population health and cardiometabolic health disparities in Black women.

Detailed description

Teen Mom 2 will assess the feasibility, acceptability, and early efficacy of a 20-week multilevel, multicomponent digital health intervention, Mama Let's Move, delivered through the University of Mississippi Medical Center's Telehealth Center for Excellence in partnership with the Special Supplemental Nutritional Program for Women, Infants, and Children (WIC) to increase physical activity (PA) and reduce sedentary behavior (SB) in pregnant, Black adolescent WIC clients in the Mississippi Delta. The Social Ecological Model and TElehealth in CHronic Disease Model provide an empirical framework for considering multiple determinants of health behavior and evaluating mechanisms of implementation and intervention impacts. At the person level, pregnant, Black adolescent (15- to 19-years) WIC clients (n=20) will be given three empirically supported behavior goals to (1) watch 2 hours or less of television per day, (2) take 10,000 steps or more per day, and (3) engage in 20 minutes or more of organized exercise like prenatal yoga or dance videos per day. The intervention is designed to build social cognition, affect, and skills using four intervention components including a Fitbit activity tracker, interactive self-monitoring text messages with tailored feedback, tailored skills training text messages and materials, and peer health coaching. At the systems-level, racially concordant young adult (20- to 25-years) WIC moms (n=8) will be hired and trained to deliver peer health coaching in a telehealth setting to first, address social needs and second, to provide support for achieving the three behavior goals. The specific aims are to: (1) assess the impact of Mama Let's Move on objectively measured light-to-moderate PA and SB from baseline (\<20-weeks' gestation) to 26- and 36-weeks' gestation in pregnant, Black adolescents; (2) use remote patient monitoring to objectively measure and characterize patterns of weight gain from baseline to 26- and 36-weeks' gestation; and (3) evaluate the feasibility and acceptability of training young adult WIC moms to provide health coaching in a telehealth setting. This study will advance public health and scientific knowledge in preparation for a future cluster randomized clinical trial by: training WIC moms to provide health coaching to pregnant, Black adolescents in a telehealth setting; developing an attention-control arm; assessing changes in adolescents' PA and SB throughout pregnancy in response to a 20-week intervention; characterizing patterns of weight gain throughout pregnancy in Black adolescents; comparing adolescents across counties and WIC providers; and evaluating an implementation partnership between WIC and the Telehealth Center of Excellence.

Conditions

• Physical Activity
• Sedentary Behavior
• Gestational Weight Gain
• Social Determinants of Health

Interventions

Type	Name	Description
BEHAVIORAL	#BabyLetsMove	The #BabyLetsMove digital health intervention uses a multi-level, systems-change approach. At the systems-level, racially concordant young adult WIC moms will be trained as health coaches. At the person level, adolescent WIC clients will be given empirically supported behavior goals, self-monitoring text messages with automated feedback, tailored skills training materials, a FitBit device, and tailored peer coaching support. The #BabyLetsMove intervention design is based on formative Teen Mom Study findings to build social cognition, affect, and skills to modify 3 concrete, achievable, and easily monitored behavioral targets: (1) Limit television viewing time to less than 2 hours per day; (2) Walk at least 10,000 steps per day; and (3) Do 20 minutes or more of exercise per day.

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-12-31
• Completion: 2026-06-01
• First posted: 2023-05-06
• Last updated: 2025-05-15

Locations

2 sites across 1 country: United States