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Идёт набор NCT05619705

Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women

Без фазы С лечением Postpartum Weight Retention Pregnancy Weight Gain Overweight and Obesity Behavior, Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Healthy for Two-Health Coaching (H42), Maintain Healthy in Pregnancy and Postpartum(mHIPP).
Кому может быть актуально
Состояния в реестре: Postpartum Weight Retention, Pregnancy Weight Gain, Overweight and Obesity, Behavior, Health. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Healthy for Two-Health Coaching (H42)
    The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
  • Поведенческое Maintain Healthy in Pregnancy and Postpartum(mHIPP)
    A brief video on maternal warning signs that is available in English or Spanish.

Первичные конечные точки

  • Change in postpartum weight (retention) [Срок оценки: Baseline and 6 months postpartum]
Вторичные конечные точки (11)
  • Change in gestational weight (gain) [Срок оценки: Baseline and immediately before delivery]
  • Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline]
  • Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS) [Срок оценки: 2 months postpartum, 4 months postpartum, 6 months postpartum]
  • Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS) [Срок оценки: 37 weeks gestation]
  • Change in maternal depression as assessed by the Edinburgh Postpartum Depression scale [Срок оценки: Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum]
  • Change in maternal sleep habits as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, 2 months postpartum, 4 months postpartum, 6 months postpartum]
  • Change in maternal social support as assessed by the Functional Social Support Questionnaire (FSSQ) [Срок оценки: Baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum]
  • Maternal healthcare utilization as assessed by Medicaid data extraction [Срок оценки: Up to 6 months after delivery]
  • Infant healthcare utilization as assessed by Medicaid data extraction [Срок оценки: Up to 6 months after delivery]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Johns Hopkins School of Nursing — Baltimore

Публикации

  • Martin LM, McKinney CD, Escobar Acosta L, Coughlin JW, Jeffers NK, Solano-Umana A, Carson KA, Wang NY, Bennett WL, Bower KM. Remote Lifestyle Intervention to Reduce Postpartum Weight Retention: Protocol for a Community-Engaged Hybrid Type I Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 7;14:e62847. doi: 10.2196/62847. PMID 39773922

Идентификаторы

NCT: NCT05619705 · IRB00307430 · 1P50MD017348-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗