An interventional study of #BabyLetsMove in Physical Activity, Sedentary Behavior and Gestational Weight Gain, sponsored by University of Mississippi Medical Center. Recruiting at 2 sites in United States. Open to female participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Prevention
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.
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of Mississippi Medical Center is the lead sponsor of 129 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Acceptability
Qualitative interviews will be conducted with teens (n=20) to explore their satisfaction with the intervention components.
Time frame: Perceptions of acceptability at 36 weeks' gestation (post-intervention)
Appropriateness
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.
Time frame: Perceptions of appropriateness at study month 30 (of 36 months).
Intensity coaching session number
The intervention intensity will be determined based on the number of coaching sessions.
Time frame: Average number of coaching sessions completed at 20 weeks (post-intervention)
Intensity coaching session length
The intervention intensity will be determined based on the length in minutes of coaching sessions.
Time frame: Average length in minutes of coaching sessions at 20 weeks (post-intervention)
Intensity text message response number
The intervention intensity will be determined based on the number of responses to interactive text messages.
Time frame: Average number of text message responses at 20 weeks (post-intervention)
Moderate-to-vigorous physical activity (MVPA)
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.
Time frame: Change in MVPA from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Sedentary behavior (SB)
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.
Time frame: Change in SB from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Moderate-to-vigorous physical activity (MVPA)
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.
Time frame: Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
Sedentary behavior (SB)
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.
Time frame: Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
Plan to share: No
Started Apr 2025 (actual). Primary completion is estimated for Dec 2025, 8 months after the start.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 8 months is below that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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