Teen Mom 2: Improving Black Adolescent Maternal Cardiometabolic Health

Physical Activity Clinical Trial

Official title:

Teen Mom 2: A Multicomponent Digital Health Intervention to Improve Black Adolescent Maternal Cardiometabolic Health in Mississippi's WIC Community

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05843903
• Other study ID #: 2022-110
• Secondary ID: 1U54GM115428
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: University of Mississippi Medical Center
• Contact: Abigail Gamble, PhD, MS
• Phone: 601-815-9065
• Email: agamble2[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Teen Mom 2 will assess the feasibility, acceptability, and early efficacy of a 20-week multilevel, multicomponent digital health intervention, #BabyLetsMove, 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 #BabyLetsMove 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

Inclusion criteria:

• 15- to 19-years
• Black or African American
• <20 weeks' gestation
• Enrolled in WIC
• Residing in 1 of 8 Mississippi Delta Counties
• English speaking
• Own or have personal use of a mobile smart phone
• Singleton pregnancy
• Plan to carry the fetus to term and keep the infant after birth
• No history of chronic medical conditions in the past year that could influence weight loss or gain

Exclusion Criteria:

• Restrictions on physical activity or exercise

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (4)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Health Resources and Services Administration (HRSA), Mississippi State Department of Health, National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gamble A, Beech BM, Blackshear C, Cranston KL, Herring SJ, Moore JB, Welsch MA. Recruitment planning for clinical trials with a vulnerable perinatal adolescent population using the Clinical Trials Transformative Initiative framework and principles of partner and community engagement. Contemp Clin Trials. 2021 May;104:106363. doi: 10.1016/j.cct.2021.106363. Epub 2021 Mar 15. — View Citation

Gamble A, Beech BM, Blackshear C, Herring SJ, Welsch MA, Moore JB. Changes in Physical Activity and Television Viewing From Pre-pregnancy Through Postpartum Among a Socioeconomically Disadvantaged Perinatal Adolescent Population. J Pediatr Adolesc Gynecol. 2021 Dec;34(6):832-838. doi: 10.1016/j.jpag.2021.06.009. Epub 2021 Jul 13. — View Citation

Gamble A, Saulters MM, Cranston KL, Jones DW, Herring SJ, Beech BM. Recruitment, Retention, and Engagement Strategies for Exercise Interventions With Rural Antenatal Adolescents: Qualitative Interviews With WIC Providers. J Public Health Manag Pract. 2020 Sep/Oct;26(5):497-502. doi: 10.1097/PHH.0000000000001027. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 will follow Hesketh et al. (2018) for 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.	Change in MVPA from baseline (<20-weeks' gestation) to 26-weeks' gestation.
Primary	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 will follow Clark et al. (2021) for SB (<100 counts per minute). Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.	Change in SB from baseline (<20 weeks' gestation) to 26-weeks' gestation.
Primary	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 will follow Hesketh et al. (2018) for 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.	Change in MVPA from baseline (<20-weeks' gestation) to 36-weeks' gestation.
Primary	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 will follow Clark et al. (2021) for SB (<100 counts per minute). Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.	Change in SB from baseline (<20-weeks' gestation) to 36-weeks' gestation.