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临床试验/NCT02867631
NCT02867631已完成不适用

A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2014年1月1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
175
试验地点
1
主要终点
Postpartum weight change

研究概览

简要总结

The Postpartum Weight Management Study is a true community-academic collaboration, bringing together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith Wright from the University of Pennsylvania to address the needs of postpartum moms. The project is an innovative intervention to help moms lose weight after the birth of their baby. Helping mothers control their weight during pregnancy and beyond can help both mother and baby avoid later obesity and cardiovascular disease. Although all women are at risk for retaining the weight gained during pregnancy, this problem is amplified for low-income, minority women. The holistic approach aims to prevent postpartum weight retention and increase breastfeeding duration with a multi-component, low-cost intervention that provides: 1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a baby carrier to combine exercise with infant care, and a pedometer to accurately measure exercise at home; 3) Enhanced peer support, including home visits and group classes with other mothers; and 4) Task-oriented professional support from nutrition and lactation experts, who assist women in developing a personalized health plan. The effectiveness of the intervention will be evaluated using a randomized control methodology among clients of MCC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •All women who speak English, and are within six weeks of delivering a live, term, single infants

排除标准

  • •Women who have multiple births or preterm (<38 weeks gestation) infants

研究组 & 干预措施

Enhanced control

No Intervention

Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only

Intervention

Experimental

6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes

干预措施: 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes (Behavioral)

结局指标

主要结局

Postpartum weight change

时间窗: Baseline and 1 year post intervention

Weight difference at one year post intervention and start of intervention

次要结局

  • Nutrition knowledge score change(Baseline, 6 weeks, 6 months, and 1 year post intervention start)
  • Dietary quality(Baseline, 6 weeks, 6 months, and 1 year post intervention)
  • Infant growth(Baseline, 6 weeks, 6 months, and 1 year post intervention start)
  • Depression(Baseline, 6 weeks, 6 months, and 1 year post intervention start)
  • Postpartum weight change(Baseline and 6 months post intervention start)
  • Waist circumference as continuous measure, in inches(Baseline, 6 weeks, 6 months, and 1 year post intervention start)
  • Back to prepregnancy weight(baseline and 1 year post intervention)
  • Back to pregnancy weight, continuous(baseline and 1 year postpartum)

研究者

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

Charmaine Smith Wright

Principle Investigator

University of Pennsylvania

研究点 (1)

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