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Идёт набор NCT07254065

Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT

Без фазы С лечением Feasibility and Acceptability Prevention Childhood Obesity

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: StEP OUT, Infant Safety Education.
Кому может быть актуально
Состояния в реестре: Feasibility and Acceptability, Prevention Childhood Obesity. 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
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Обзор

The goal of this clinical trial is to test an online program that teaches healthy habits during pregnancy and infant to prevent early child obesity in Latino families. Specifically, this pilot trial will determine how well we can deliver and test the effects of the program, and how acceptable it is to participants. The main question it aims to answer are: • Is a randomized controlled trial of StEP OUT versus infant safety education control feasible to conduct and acceptable to participants? Researchers will compare StEP OUT to infant safety education control to see if participants enroll in and engage with the program, complete surveys, and learn the content we are teaching. Participants will: * Be assigned to receive StEP OUT or Infant Safety Education * If receiving StEP OUT, they will participant in group text chats and video calls * If receiving Infant Safety Education, they will receive periodic text messages with helpful links and tips * Respond to periodic surveys

Подробное описание

Our objective is to conduct a pilot RCT to evaluate the acceptability, feasibility, and preliminary effectiveness of StEP OUT.

Hypothesis: The intervention and control conditions of StEP OUT will be acceptable to families and feasible, as measured by recruitment, randomization, retention, usability, and fidelity. H3b (exploratory): Families exposed to StEP OUT will have improved obesity-related outcomes (knowledge, styles, practices, and infant adiposity) compared to controls.

Вмешательства

  • Поведенческое StEP OUT
    The program consists of five interactive, virtual, group sessions (two prenatal, three post-natal) with a registered dietician/lactation counselor and other women/families of similar gestational age/infant age. Participants discuss maternal nutrition, responsive feeding techniques (breast and bottle), infant feeding cues, and non-feeding soothing methods. Participants are also invited to participate in a moderated WhatsApp Chat with each other to foster additional social engagement and connectio
  • Поведенческое Infant Safety Education
    This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information.

Первичные конечные точки

  • Acceptability [Срок оценки: From enrollment through the end of the study after child age 6 months]
Вторичные конечные точки (1)
  • Feasibility [Срок оценки: From enrollment to study completion after infant age 6 months.]

Критерии участия

Критерии включения

  • Pregnant with singleton of 24 to 32 weeks estimated gestational age
  • Self-identify as Hispanic/Latinx
  • Speak fluent English or Spanish
  • At least 18 years of age
  • Has a phone or device to participate in video calls
  • Receiving or eligible to receive New York State Medicaid benefits

Критерии исключения

  • Diminished mental capacity
  • Serious medical or psychiatric illness
  • Fetal condition expected to substantially influence infant feeding (anatomic abnormality, such as cleft lip/palate or one that will require surgery within the first six months of life, chromosomal abnormality, such as Down's syndrome or other trisomy, etc.)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Northwell Health — New Hyde Park

Идентификаторы

NCT: NCT07254065 · 21-1078 Aim 3 · K23HL159326

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗