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Идёт набор NCT05000645

Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women

Без фазы С лечением Pregnancy Weight Gain

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: Grocery delivery, Unsweetened beverage delivery.
Кому может быть актуально
Состояния в реестре: Pregnancy, Weight Gain. Базовые параметры: 14 лет — 26 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 →

Обзор

This project will increase knowledge about how a simple intervention, grocery delivery, impacts weight gain and diet among low-income pregnant young women. Results can then be used to support other pregnant young women.

Подробное описание

The overall aim of this study is to determine whether an intervention that facilitates receipt of healthy food and unsweetened beverages will promote healthy weight gain and improve diet quality among pregnant young women age 14-26 living in Michigan. This hypothesis will be tested in a three-arm randomized controlled trial (RCT) using a parallel design; Arm 1: Usual WIC (Control), Arm 2: Usual WIC + Delivery of WIC-approved food, Arm 3: Usual WIC + Delivery of WIC-approved food PLUS unsweetened beverages. Three arms are necessary because our goal is to make three distinct comparisons. First, we need to determine the effect of food delivery (Arm 2) compared to usual WIC (Arm 1). Second, we need to determine the combined effect of food plus unsweetened beverage delivery (Arm 3) compared to usual WIC (Arm 1). Finally, we need to evaluate the effect of food delivery (Arm 2) compared with food plus unsweetened beverage delivery (Arm 3) to determine the individual impact of replacing SSBs, a major contributor to excessive pregnancy weight gain in our population. Our study does not assess the impact of delivering only unsweetened beverages compared to usual WIC because the potential policy implication is the delivery of WIC benefits. A widespread program that only delivers unsweetened beverages is not likely.

Upon completion of baseline screening and assessments, 570 pregnant young women will be randomly assigned to either the control group or one of the two experimental groups. Enrollment in the study is rolling and starts as early as possible in the pregnancy (must be before 21 weeks gestation). The intervention period begins at enrollment and continues to the end of pregnancy/birth. Thus, each participant will be enrolled for approximately seven months post-randomization. During the intervention period, all groups will receive usual WIC food, nutritional assessment, and counseling benefits, including monthly intensive nutritional counseling sessions based on a state-approved curriculum with trained nutritionists and peer counselors.

* The control group (Arm 1) will receive usual WIC counseling and food benefits loaded onto their electronic benefits card (EBT) for them to use in person at approved grocery stores. * The first experimental group (Arm 2) will receive usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods. * The second experimental group (Arm 3) will receive usual WIC counseling and food benefits as well as twice-monthly home deliveries of WIC-approved foods PLUS unsweetened beverages to replace their current SSB intake.

The primary outcome is weight gain during pregnancy as defined by the Institute of Medicine (IOM)/National Academy of Medicine (NAM) Guidelines. Secondary outcomes include Healthy Eating Index (HEI) scores and dietary intake of fruits, vegetables, whole grains, and SSBs; infant birth weight; and prenatal and delivery complications identified through postpartum medical record review (e.g., small/large for gestational age, gestational diabetes, hypertensive disorders, operative delivery).

Вмешательства

  • Поведенческое Grocery delivery
    Each food delivery will contain approximately $35 worth of fresh fruits, vegetables, dairy products, and whole grain foods. These foods are not meant to supplant regular meals, rather make healthy eating more convenient.
  • Поведенческое Unsweetened beverage delivery
    Participants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake.

Первичные конечные точки

  • Weekly weight gain in pregnancy [Срок оценки: Up to delivery, approximately 40 weeks]
  • Total weight gain in pregnancy [Срок оценки: At delivery, approximately 40 weeks]
Вторичные конечные точки (4)
  • Dietary Quality as measured by the Healthy Eating Index (HEI) Score [Срок оценки: Up to delivery, approximately 40 weeks]
  • Occurrence of prenatal complications [Срок оценки: Delivery, approximately 40 weeks]
  • Occurrence of delivery complications [Срок оценки: Delivery, approximately 40 weeks]
  • Baby birth weight [Срок оценки: Delivery, approximately 40 weeks]

Критерии участия

Критерии включения

  • Gestational age ≤ 20 weeks
  • Text message capability
  • Healthy singleton pregnancy
  • Nulliparous
  • Consume sugar sweetened beverages (SSBs)
  • Living within delivery zone of a grocery delivery service

Критерии исключения

  • Non-English speaking
  • Participants who live at the same address
  • Physical, mental, or cognitive handicaps that prevent participation
  • High risk pregnancy requiring specialized care (including pre-existing diabetes)

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
  • The University of Michigan — Ann Arbor

Публикации

  • Waselewski M, Plegue M, Sonneville K, Resnicow K, Ghumman A, Ebbeling C, Mahmoudi E, Sen A, Wolfson JA, Chang T. Grocery Delivery to Support Healthy Weight Gain Among Pregnant Young Women With Low Income: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 5;11(8):e40568. doi: 10.2196/40568. PMID 35930351

Идентификаторы

NCT: NCT05000645 · HUM00190614 · 1R01HD101522

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗