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. 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/m2 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. 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. NCT03866902. (March 7, 2019).

中文翻译：

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健康母亲-健康儿童研究的基本原理、设计和方法：随机对照试验


超重或肥胖的西班牙裔妇女和儿童在以后的生活中面临患上糖尿病前期、2 型糖尿病和心血管疾病的风险。针对西班牙裔妇女及其 3-5 岁孩子的跨学科干预措施，旨在改善营养和体育活动行为、控制母亲的肥胖和体重，并防止孩子过度肥胖和体重增加，有望打破代际循环。使用随机两组、重复测量的实验设计，拟议研究的目标是调查为期 12 周的营养和身体活动计划（包括教育、应对技能培训和家庭干预）对西班牙裔妇女及其她们的影响。 3-5岁儿童。该计划包括为期 6 个月的持续每月接触，以帮助超重和肥胖的西班牙裔母亲及其子女改善肥胖、体重（儿童的轨迹）、健康行为（营养和身体活动）和自我效能。我们将与两名具有联邦资格的健康机构合作北卡罗来纳州达勒姆县和查塔姆县的部门招募参与者。我们将与社区中心合作提供干预措施。总共 294 名 BMI ≥ 25 kg/m2 的西班牙裔女性和 294 名 BMI ≥ 25th 百分位的西班牙裔 3-5 岁儿童将在 4 年时间内入组，并随机分配到实验组或同等关注对照组。数据将在时间 1（0 个月[基线]）至时间 2（9 个月[干预完成]）和时间 1 至时间 3（15 个月[研究人员没有联系的 6 个月后]）收集。收集的数据将包括母亲和儿童的肥胖和体重（主要结果）。 次要结果包括母亲和儿童的健康行为和自我效能。我们还将评估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。迫切需要减少西班牙裔女性的超重和肥胖，并减缓西班牙裔儿童的肥胖和体重增加轨迹，以降低发病率、死亡率和未来的医疗保健成本。 NCT03866902。 （2019 年 3 月 7 日）。