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临床试验/NCT02620059
NCT02620059已完成不适用

Development and Evaluation of a Lifestyle Intervention Program for Women' Weight Reduction After Childbirth

Tehran University of Medical Sciences0 个研究点目标入组 100 人开始时间: 2016年9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
100
主要终点
Body weight changes

研究概览

简要总结

The aim of this study is to examine the impact of lifestyle intervention on postpartum weight loss. So the investigators will have two groups in this study. In Experimental group women will receive the Healthy Lifestyle Intervention. This intervention will have been delivered during 12 weeks. In Control group women will receive general information via pamphlet about postpartum period and tips for stress management.

详细描述

This study will be conducted in two phases. In the first phase , the investigators will conduct a cross-sectional study to assess factors related to the healthy lifestyle after childbirth based on the PRECEDE model. Regarding results of the study, the investigators will plan and implement a lifestyle promoting intervention and will evaluate the effect of the intervention on weight reduction among postpartum women.

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

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Lactating
  • Non-smoking
  • Full-term birth
  • Lack of medical problems
  • Lack of any pregnancy-related complications (eg, multiple pregnancy, fetal anomalies, fetal or maternal complications in current or previous pregnancy, and hypertension in pregnancy).
  • Nonparticipation in other studies which may affect the results.
  • 18.5≤ BMI≤29 before pregnancy
  • Women who are sedentary according to the International Physical Activity Questionnaire.

排除标准

  • Unwilling to continue participation in the study
  • Pregnancy during the study
  • Suffering physical problems during the study
  • Smoking after birth

研究组 & 干预措施

Lifestyle Intervention

Experimental

Behavioral: Lifestyle Intervention These women will receive the Healthy Lifestyle Intervention. This intervention will have been delivered during 12 weeks, which will be Distance learning program (multimedia or internet). During the intervention (12 weeks) and follow up period, women will receive not only motivational messages through the Short Message System (SMS) but also a pedometer to record their steps.The intervention will focus on women increasing physical activity (walking) to 10'000 steps per day and receiving healthy eating guidelines.

This intervention curriculum will cover topics related to healthy eating, physical activity, and stress management during postpartum. General information about postpartum period will also be provided.

干预措施: Lifestyle Intervention (Behavioral)

Control

No Intervention

These women will receive general information via pamphlet about postpartum period and tips for stress management.

结局指标

主要结局

Body weight changes

时间窗: Changes from baseline at 12 months postpartum

The investigators will assess body weight changes through BMI (kg/m2)

次要结局

  • Physical activity changes(Changes from baseline at 12 months postpartum)
  • Dietary intake changes(Changes from baseline at 12 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

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