健康母亲-健康儿童研究的基本原理、设计与方法：一项随机对照试验。

Rationale, design, and methodology for the healthy mothers-healthy children study: a randomized controlled trial.

作者信息

Berry Diane C, Gonzales Cecilia, Montano Nilda Peragallo, Perreira Krista M, Ammerman Alice S, Crandell Jaime, Evenson Kelly R, Faith Myles S, Waters Hugh, Linares Crystal, Cόrtes Yamnia I, Perrin Eliana M

机构信息

1School of Nursing, The University of North Carolina at Chapel Hill, Campus Box 7460, Chapel Hill, North Carolina 27599-7460 USA.

2Department of Social Medicine, The University of North Carolina at Chapel Hill, 333 South Columbia Street, MacNider Hall, Room #348 / CB #7240, Chapel Hill, NC 27599-7240 USA.

出版信息

BMC Nutr. 2019 Dec 16;5:58. doi: 10.1186/s40795-019-0322-7. eCollection 2019.

DOI:10.1186/s40795-019-0322-7

PMID:32153971

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7050912/

Abstract

BACKGROUND

Hispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. Interdisciplinary interventions which target Hispanic women and their 3-5-year old children to improve nutrition and physical activity behaviors, manage adiposity and weight in mothers, and prevent excessive adiposity and weight gain trajectory in their children offer promise to break the intergenerational cycle.

METHODS

Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and physical activity program including education, coping skills training, and home-based intervention in Hispanic women and their 3-5-year old children. The program includes 6 months of continued monthly contact to help overweight and obese Hispanic mothers and their children improve adiposity, weight (trajectory for children), health behaviors (nutrition and physical activity), and self-efficacy We will partner with two federally qualified health departments in Durham and Chatham counties, North Carolina to enroll participants. We will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI ≥ 25 kg/m and 294 Hispanic 3-5-year old children with a ≥ 25th BMI percentile will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months [baseline]) to Time 2 (9 months [completion of the intervention]) and Time 1 to Time 3 (15 months [after 6 months with no contact from the study staff]). Data collected will include adiposity and weight in mothers and children (primary outcomes). Secondary outcomes will include health behaviors and self-efficacy in the mothers and in the children. We will also evaluate the cost of delivering the program for public health departments. We will use general linear mixed models to test the hypotheses.

DISCUSSION

Decreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs.

TRIAL REGISTRATION

NCT03866902. (March 7, 2019).

摘要

背景

超重或肥胖的西班牙裔妇女和儿童在日后患糖尿病前期、2型糖尿病和心血管疾病的风险较高。针对西班牙裔妇女及其3至5岁儿童的跨学科干预措施，旨在改善营养和身体活动行为、控制母亲的肥胖和体重，并防止儿童过度肥胖和体重增加轨迹，有望打破代际循环。

方法

采用随机两组重复测量实验设计，拟开展研究的目标是调查一项为期12周的营养和身体活动计划的效果，该计划包括教育、应对技能培训以及针对西班牙裔妇女及其3至5岁儿童的家庭干预。该计划包括连续6个月每月进行联系，以帮助超重和肥胖的西班牙裔母亲及其子女改善肥胖状况、体重（儿童的体重轨迹）、健康行为（营养和身体活动）以及自我效能感。我们将与北卡罗来纳州达勒姆县和查塔姆县的两个联邦合格卫生部门合作招募参与者。我们将与社区中心合作实施干预措施。在4年时间内，共将招募294名BMI≥25kg/m²的西班牙裔妇女和294名BMI百分位数≥25的3至5岁西班牙裔儿童，并将其随机分为实验组或同等关注对照组。将在时间1（0个月[基线]）至时间2（9个月[干预完成]）以及时间1至时间3（15个月[研究人员停止联系6个月后]）收集数据。收集的数据将包括母亲和儿童的肥胖和体重（主要结果）。次要结果将包括母亲和儿童的健康行为和自我效能感。我们还将评估为公共卫生部门实施该计划的成本。我们将使用一般线性混合模型来检验假设。