Clinical trial NCT05843903: Teen Mom Study Feasibility Trial
Official title: Teen Mom Study Feasibility Trial: A Multicomponent Digital Health Intervention to Improve Cardiometabolic Health in Pregnant Black Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Sedentary Behavior
Gestational Weight Gain
Social Determinants of Health
Keywords: implementation science
pragmatic clinical trial
telemedicine
health disparity, minority and vulnerable populations
behavior and behavior mechanisms
adolescent pregnancy
black maternal health
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Mississippi State Department of Health
name: Health Resources and Services Administration (HRSA)
name: National Institute of General Medical Sciences (NIGMS)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-05-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: Perceptions of acceptability at 36 weeks' gestation (post-intervention)
measure: Appropriateness
timeFrame: Perceptions of appropriateness at study month 30 (of 36 months).
measure: Intensity coaching session number
timeFrame: Average number of coaching sessions completed at 20 weeks (post-intervention)
measure: Intensity coaching session length
timeFrame: Average length in minutes of coaching sessions at 20 weeks (post-intervention)
measure: Intensity text message response number
timeFrame: Average number of text message responses at 20 weeks (post-intervention)
Secondary outcomes:
measure: Moderate-to-vigorous physical activity (MVPA)
timeFrame: Change in MVPA from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
measure: Sedentary behavior (SB)
timeFrame: Change in SB from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
measure: Moderate-to-vigorous physical activity (MVPA)
timeFrame: Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
measure: Sedentary behavior (SB)
timeFrame: Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Abigail Gamble, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.