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临床试验/NCT05843903
NCT05843903招募中不适用

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

University of Mississippi Medical Center3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
3
主要终点
Acceptability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Restrictions on physical activity or exercise

结局指标

主要结局

Acceptability

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Moderate-to-vigorous physical activity (MVPA)(Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation.)
  • Sedentary behavior (SB)(Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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