Teen Mom Study Feasibility Trial
- Conditions
- Gestational Weight GainSedentary BehaviorPhysical ActivitySocial Determinants of Health
- Interventions
- Behavioral: #BabyLetsMove
- Registration Number
- NCT05843903
- Lead Sponsor
- University of Mississippi Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
Not provided
- Restrictions on physical activity or exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description #BabyLetsMove #BabyLetsMove There are four digital components to the intervention including Fitbit activity tracker, interactive self-monitoring and tailored feedback text messages, tailored skills training text messages and materials, and peer health coaching.
- Primary Outcome Measures
Name Time Method Acceptability Perceptions of acceptability at 36 weeks' gestation (post-intervention) Qualitative interviews will be conducted with teens (n=20) to explore their satisfaction with the intervention components.
Intensity coaching session length Average length in minutes of coaching sessions at 20 weeks (post-intervention) The intervention intensity will be determined based on the length in minutes of coaching sessions.
Intensity text message response number Average number of text message responses at 20 weeks (post-intervention) The intervention intensity will be determined based on the number of responses to interactive text messages.
Intensity coaching session number Average number of coaching sessions completed at 20 weeks (post-intervention) The intervention intensity will be determined based on the number of coaching sessions.
Appropriateness Perceptions of appropriateness at study month 30 (of 36 months). Qualitative interviews will be conducted with peer health coaches (n=2) about their experience delivering coaching, case management support, and satisfaction with their role as a coach. Interviews with WIC leaders (n=3) and local WIC providers (n=5) will explore opinions on delivering coaching in a telehealth setting to enhance WIC's capacity to serve rural communities.
- Secondary Outcome Measures
Name Time Method Moderate-to-vigorous physical activity (MVPA) Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation. GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts: moderate (1952 - 5724 counts per minute) and vigorous (\>5724 counts per minute) PA. Wear-time compliance will include 20 hours per day, \> 4 days per week including 1 weekend day.
Sedentary behavior (SB) Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation. GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts: SB (\<100 counts per minute). Wear-time compliance will include 20 hours per day, \> 4 days per week including 1 weekend day.
Trial Locations
- Locations (1)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States