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临床试验/NCT03480048
NCT03480048已完成不适用

Breastfeeding Support and Weight Management for Black Women: A Dual Intervention

Michigan State University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Number of Participants Still Breastfeeding at 20 Weeks Postpartum

研究概览

简要总结

This study, in African American mothers in Detroit, will test an intervention that combines home visiting by experienced peer counselors with a smart phone-based weight control program. The investigators are trying to help mothers breastfeed their babies longer, and also help them get back to the weight they were before they were pregnant. This trial will help the investigators to guide policies in the state of Michigan and has the potential to improve the health of both mothers and babies everywhere.

详细描述

Excessive pregnancy-related weight retention is an important determinant of obesity and is more common among African American women. At the same time, breastfeeding, which has been recommended as a strategy to decrease weight retention is lowest among African American women. This racial disparity in breastfeeding may partly explain the disparity in obesity, but even if the two are not causally related, a dual intervention designed to increase breastfeeding duration and decrease postpartum weight retention makes practical sense because both are associated with the same critical postpartum time window.

For this study, the investigators will incorporate a postpartum weight management component into an effective breastfeeding support program. This dual intervention will use a combination of in-person, telephone, and interactive web/mobile-based health counseling to provide education and support for breastfeeding difficulties and postpartum weight management. The intervention will be delivered by peer counselors who will be trained to provide support using motivational interviewing techniques with consultation by experts. The investigators have designed the dual intervention to provide encouragement, information, and problem-solving assistance at the appropriate pre or postpartum stage for both breastfeeding support and maternal weight management. The mixed delivery mode has proven effective in other settings and is important to build a trusting relationship while allowing frequent and flexible methods for communicating during this vulnerable time in a new mom's life. The overall goal of this developmental/exploratory R21 proposal is to gather pilot data to effectively refine the intervention so that it can be tested in a larger, longer study using a factorial design in a future R01 phase. The investigators will recruit, in one large inner-city prenatal care clinic (Henry Ford Health System, Detroit, MI), pregnant African American women (32-36 weeks gestation) who are considering breastfeeding (n=80), randomize them to the intervention or to a usual care group, and follow all participants to 20 weeks postpartum. The specific aims are to: 1) test feasibility; 2) assess acceptability; and 3) estimate the effect size of the intervention at 20 weeks postpartum relative to the usual care group on (1) breastfeeding duration and (2) postpartum weight retention. This project is significant because the combined intervention is designed to work synergistically on two interrelated, highly prevalent problems that disproportionately disadvantage African American families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant, African American women, aged 18 and older, intending to breastfeed, ability to complete surveys in English

排除标准

  • Contraindications to breastfeeding, high-risk pregnancy,

研究组 & 干预措施

Breastfeeding and weight loss support

Experimental

Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.

干预措施: Breastfeeding and weight loss support (Behavioral)

Usual care

No Intervention

Participants receive usual care from their prenatal care provider.

结局指标

主要结局

Number of Participants Still Breastfeeding at 20 Weeks Postpartum

时间窗: 20 weeks postpartum

Count of women who report any breastfeeding at 20 weeks postpartum

Change in Weight From Baseline

时间窗: Baseline and 20 weeks postpartum

Weight at 20 weeks postpartum minus pre-pregnancy weight.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean Kerver

Assistant Professor

Michigan State University

研究点 (2)

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