Assessing the Feasibility of a Prenatal Mobile App in Pregnant African American Women: The Mindful Maternity Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acceptability of the intervention
研究概览
简要总结
The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are:
- Is the Down Dog prenatal yoga app feasible for AA pregnant women?
- How does mental and physical health change after using the Down Dog app for 12-weeks?
- What cultural adaptations to the Down Dog app are needed?
The study lasts for 12 weeks and participants are asked to:
- do prenatal yoga with the app for at least 20 min/day, three days/week, from home
- wear a Garmin Vivosmart 5 watch daily
- complete four online surveys
- complete an optional virtual interview
This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes.
详细描述
Recruitment: The investigators will recruit 50 pregnant African American women from local prenatal clinics, non-profits, and social media.
Eligibility: All interested participants will complete a web-based eligibility screener (~5 minutes). Eligible participants will be asked to schedule a virtual intake appointment to review the consent form with a research team member.
Procedures: Participants must sign an informed consent and complete a Physical Activity Readiness Medical Examination (PARmed-X) for Pregnancy with their healthcare provider before beginning the study. Once participants sign the consent and return a completed PARmed-X form, they will be asked to schedule an in-person enrollment appointment.
During the in-person enrollment appointment, participants will receive a free yoga mat and Garmin Vivosmart 5, and study materials. A research team member will set up the Garmin device for the participant. Participants will be asked to resume normal activities for one week before beginning the intervention and to complete a baseline survey.
After one week of baseline data collection, a research team member will send the participant an email with instructions to download/use the prenatal yoga mobile app and other relevant study materials. Participants will then engage in prenatal yoga using the mobile app for at least 20 min/day, 3 days/week for the next 12 weeks. Participants will receive a mid-intervention survey at 6 weeks, a post-intervention survey at 12 weeks, and will have an opportunity to complete a virtual interview when the study is over. Within 1-2 weeks after the participants' due date, a research team member will send an online birth outcomes survey to collect self-reported birth outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants will be included in the study if they:
- •Are 18-46 years of age (childbearing age)
- •Reside in San Diego Metropolitan Area
- •Speak English
- •Are between 13-28 weeks when intervention starts
- •Are primiparous (giving birth for the first time)
- •Have a singleton pregnancy (pregnant with only one baby)
- •Are yoga naive (<60 min/month for past 6 months)
- •Have access to smartphone/mobile device
- •Willing to wear a wrist worn fitness tracker for the duration of the study
- •Willing to download and use 3 mobile apps for the duration of the study
- •Identify as Black or African American
- •Return a completed Physical Activity Readiness Medical Examination (PARmed-X) for Pregnancy form (HCP approves participation in prenatal PA program before beginning intervention)
排除标准
- •High-risk pregnancy
- •Severe psychiatric disorder or substance abuse
- •Denial of physical activity participation from physician
研究组 & 干预措施
Down Dog Prenatal Yoga App
Prenatal yoga via Down Dog Prenatal Yoga Mobile App 20 minutes a day, 3 days per week, for 12 weeks.
干预措施: Down Dog Prenatal Yoga App (Behavioral)
结局指标
主要结局
Acceptability of the intervention
时间窗: Post intervention (12 weeks)
Assessed using an investigator-developed questionnaire using a 5 point likert scale from strongly agree to strongly disagree. Acceptability benchmark: \> 70% of participants report the intervention to be satisfactory, intend to continue using the app, and perceive the app content to be appropriate for pregnancy.
Ease of recruitment
时间窗: Assessed at enrollment
Assessed by evaluating enrollment rate. Recruitment benchmark: \>8 participants will be enrolled each month on average.
Retention
时间窗: Assessed across 12-week study period
Assessed by calculating the proportion of enrolled participants that complete intervention vs withdrawals. Retention benchmark: ≥70% (N=35) complete the intervention.
Demand of the intervention
时间窗: Assessed across 12-week study period
Assessed by measuring actual use of the mobile app with data analytics provided from Down dog. Demand benchmark: \>70% of participants complete at least 75% of their weekly prescribed minutes (i.e., ≥ 45 of 60 minutes per week).
次要结局
- Perinatal Depression(Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks))
- Perceived stress(Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks))
- Mindfulness(Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks))
- Subjective physical activity(Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks))
- Objective physical activity (intensity)(Daily for 12 weeks)
- Cardiac health (heart rate variability)(Daily for 12 weeks)
- Birth outcomes (gestational age)(Post-delivery (~2 weeks after delivery of baby))
- Birth outcomes (intervention used for delivery)(Post-delivery (~2 weeks after delivery of baby))
- Birth outcomes (maternal weight)(Post-delivery (~2 weeks after delivery of baby))
- Cultural adaptations(Post-Intervention (12 weeks))
- Self-awareness(Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks))
- Birth outcomes (birth weight)(Post-delivery (~2 weeks after delivery of baby))
- Birth outcomes (type of delivery)(Post-delivery (~2 weeks after delivery of baby))
- Birth outcomes (pregnancy-related disorders)(Post-delivery (~2 weeks after delivery of baby))
- Discrimination(Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks))
- Objective physical activity (steps)(Daily for 12 weeks)
- Cardiac health (heart rate)(Daily for 12 weeks)
研究者
Jennifer Green
Assistant Professor
San Diego State University