Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in postpartum weight (retention)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of H42-HV integrated into home visiting compared with usual home visiting services in reducing postpartum weight retention (difference between pre-pregnancy weight and weight at 6 months postpartum) among pregnant and postpartum participants. The overall goal is to improve long-term cardiometabolic health.
详细描述
There are four components of the H42-HV intervention: 1) Health coaching calls; 2) H42 web-based app for learning activities and goal setting functions; 3) Tracking of health behaviors (diet, exercise), and 4) Self-weighing (weekly). The overarching behavioral goals of the intervention are for participants to have lower postpartum weight retention at 6 months after delivery. Weight and behavioral goals will be promoted through the COACH Plan, a behavioral model guiding coaching calls, behavioral tracking targets and learning activities. Coaches will refer to home visitors for additional support and community resources, based on an established protocol.
- Telephone health coaching calls by trained health coaches. Calls start at enrollment, between 20-33-weeks gestation through 6 months postpartum. Although coaching calls will occur by phone or Zoom (~20 mins), when possible, some coach contact could occur at the time of home visits in person.
- Online interactive learning activities. Literacy adaptation ensured Learning Activities are at <5th grade reading level. All activities are translated into Spanish and culturally adapted to create a parallel program. Online learning activities contain embedded images (people and settings) that reflect the diversity of the investigators' target population, examples of activities that are readily available in the community and maximize the use of white space, large text and simple graphics to enhance readability and accessibility of the educational content. The investigators enhanced the platform to enable an interactive goal-setting functionality for participants to set health goals paced with participants' Learning Activities and calls. The online program is maintained and monitored by the study's health coach managers.
- Health behavior tracking (diet and exercise). Participants will receive specific skill-building on how to track diet and exercise behaviors via mainstream mobile app or paper/pencil, using procedures from the investigators' current trial. Coaches will be able to discuss tracking data with participants. Mainstream tracking apps are available in both Spanish and English.
- Weekly self-weighing. Participants will be asked to weigh themselves weekly at home using the participants' study scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant, ≤33 weeks gestation
- •Singleton pregnancy
- •Pre pregnancy BMI≥25.0 Kg/m^2 (calculated based on self-reported pre pregnancy height and weight)
- •Able to provide informed consent
- •English or Spanish speaking
- •Completion of screening and baseline data collection
- •Willing to participate in the intervention and data collection procedure (e.g., home weights)
排除标准
- •Type 1 diabetes or taking insulin prior to delivery
- •Pregnant with multiple fetuses
- •Unable to walk 1 block without pain or shortness of breath
- •Not cleared by the study's clinicians or home visiting program staff
- •Planning to relocate from area during next 1 year
- •Active substance abuse disorder (except marijuana)
- •Psychiatric or substance use related hospitalization in past 1 year
- •Active eating disorder
研究组 & 干预措施
Healthy for Two-Health Coaching (H42)
Those assigned to the intervention group will receive the 8 to 11 month H42 health coaching intervention in addition to usual home visiting and usual prenatal and postpartum care clinical services. Intervention duration will depend on the participant's gestational age at the of enrollment. Participants can be enrolled as early in pregnancy as 20 weeks gestation and as late as 33 weeks gestation. All participants would be enrolled for 6 months postpartum. Therefore, the minimum time in the intervention would be 8 months and maximum would be 11 months.
干预措施: Healthy for Two-Health Coaching (H42) (Behavioral)
Maintain Health in Pregnancy and Postpartum (mHIPP)
Those assigned to the "usual home visiting plus" comparison group, called maintain health in pregnancy and postpartum (mHIPP), will receive the typical, evidence-based experience in participants' home visiting program in addition to the participants' usual prenatal and postpartum care clinical services. In addition, the investigators will provide a brief (less than 5 minutes) maternal warning signs educational video that is available in English or Spanish. The video was developed for a home visiting client audience and is publicly available, https://mdmom.org/warningsigns.
干预措施: Maintain Healthy in Pregnancy and Postpartum(mHIPP) (Behavioral)
结局指标
主要结局
Change in postpartum weight (retention)
时间窗: Baseline and 6 months postpartum
Difference between pre-pregnancy weight and weight at 6 months postpartum. Pre-pregnancy weight (baseline) will be self-reported and then confirmed by prenatal clinic medical records. 6 month postpartum weight will be obtained via BodyTrace study scales provided to all participants.
次要结局
- Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ)(Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum)
- Change in maternal physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)(Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum)
- Maternal smoking habits as assessed by the Center for Disease Control and Prevention Pregnancy Risk Assessment Monitoring System (CDC PRAMS)(Baseline)
- Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)(2 months postpartum, 4 months postpartum, 6 months postpartum)
- Change in maternal depression as assessed by the Edinburgh Postpartum Depression scale(Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum)
- Change in gestational weight (gain)(Baseline and immediately before delivery)
- Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)(37 weeks gestation)
- Change in maternal social support as assessed by the Functional Social Support Questionnaire (FSSQ)(Baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum)
- Maternal healthcare utilization as assessed by Medicaid data extraction(Up to 6 months after delivery)
- Change in maternal sleep habits as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, 2 months postpartum, 4 months postpartum, 6 months postpartum)
- Infant healthcare utilization as assessed by Medicaid data extraction(Up to 6 months after delivery)