Community Translation of the Expecting Study

Официальное название

Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D

Обзор

The Expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved IRB submission (Protocol 202954). The current project will seek to engage community stakeholders to translate Expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.

Подробное описание

The aim of this study is to adapt and determine acceptability, feasibility and fidelity of the research- clinic-based Expecting intervention with pregnant women with obesity in community settings. Specifically, the investigators will show effective application of the Replicating Effective Programs (REP) framework (e.g., fidelity, feasibility, acceptability) to translate the research clinic-based intervention to community settings. REP provides a four-phase process for implementing evidence-based interventions and has demonstrated effective application to translate clinical interventions to community settings. Built into the REP framework is the collection of feedback from community stakeholders, iterative piloting of the intervention in the community, and a process for standardizing the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. The investigators will randomize half to receive the community-adapted Expecting intervention (Intervention, N=30) and half to receive standard of care (Control, N=30).

Вмешательства

• Поведенческое Exercise in Pregnancy
  Women in this group will participate in psychical activity 3 times per week in their community setting.

Первичные конечные точки

• Feasibility of Intervention Measure:38 weeks [Срок оценки: 38 weeks]
• Acceptability of Intervention Measure: 38 weeks [Срок оценки: 38 weeks]

Вторичные конечные точки (5)

• Number of intervention sessions completed [Срок оценки: 15 weeks through 38 weeks]
• Number of minutes of physical activity [Срок оценки: Change from Baseline to Delivery and 6 Months Post Delivery]
• Body Mass Index [Срок оценки: Change from Baseline to Delivery and 6 Months Post Delivery]
• Blood Pressure [Срок оценки: Change from Baseline to Delivery and 6 Months Post Delivery]
• Total Cholesterol from Lipid Panel [Срок оценки: Change from Baseline to Delivery and 6 Months Post Delivery]

Критерии участия

Критерии включения

• (a) Body Mass Index > 30,
• (b) singleton pregnancy,
• (c) between 11-15 weeks of pregnancy (at enrollment),
• (d) Do not currently meet recommended guidelines of 150 min of activity per week
• (e) cleared by physician

Критерии исключения

• (a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions)
• (b) illicit drug use.

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

• Arkansas Children's Nutrition Center — Little Rock

Публикации

• Swindle T, Martinez A, Borsheim E, Andres A. Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol. BMJ Open. 2020 Sep 6;10(9):e038582. doi: 10.1136/bmjopen-2020-038582. PMID 32895286

Идентификаторы

NCT: NCT04298125 · 260132

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗