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临床试验/NCT02516865
NCT02516865Unknown1 期

Practical Approaches to Exercise in Moms

Maxine Mendelson1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
发起方
入组人数
30
试验地点
1
主要终点
Change in baseline body weight at 12-months postpartum.

研究概览

简要总结

This project aims to test the feasibility of a practical physical activity intervention for postpartum women, incorporating the use of body weights worn during typical daily activities.

详细描述

We are piloting a 3-arm, unblinded, randomized controlled trial in postpartum women; with 10 participants in each study group. Women will be recruited at 2-6 months postpartum, with the intervention lasting through 12 months postpartum. Data collection will include:1) Physical activity; 2) Maternal body composition; 3) Questionnaires to assess:motivation to adopt healthy behaviors, body attitudes, infant feeding practices; 4) Process evaluation to assess: likes and dislikes about the intervention program, suggestions for improving the intervention, reasons for leaving the study. The proposed study time period is 6 months for study recruitment, 18 months to carry out the study, and 6 months for data analysis (total 2 years).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
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
是

入选标准

  • •2-6 months postpartum women

排除标准

  • •Premature birth
  • •History of serious illness
  • •Medically incapable of low-intensity exercise
  • •Currently taking medications that cause weight loss

研究组 & 干预措施

Group 2

Experimental

干预措施: Fitbit activity tracker (Device)

Group 2

Experimental

干预措施: Ankle weights (Device)

Group 3

No Intervention

Group 1

Experimental

干预措施: Fitbit activity tracker (Device)

结局指标

主要结局

Change in baseline body weight at 12-months postpartum.

时间窗: Baseline and 12 months

次要结局

未报告次要终点

研究者

发起方
Maxine Mendelson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maxine Mendelson

Clinical Research Coordinator

Nationwide Children's Hospital

研究点 (1)

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