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临床试验/NCT01343238
NCT01343238已完成不适用

Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study

Göteborg University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2007年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
2
主要终点
Body weight

研究概览

简要总结

The study will investigate whether physical exercise, or dietary restrictions, or a combination of both, among overweight and obese postpartum women lead to a significantly larger reduction in weight in a longer perspective, compared to similar women not receiving the intervention. The study also will investigate the effects on body composition, cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68 women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1) physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr after trial initiation. To date only studies showing short term (12 wk) effects exist. Our study is the first to include four intervention groups, so that separate effects of physical activity and dietary restriction and their interaction, can be assessed. Further, the investigators will estimate effects on body composition taking body water into account and estimate total energy expenditure with higher precision than previously. Overweight and obesity is an escalating problem in Sweden. Sustainable weight reduction programs are urgently needed. During the postpartum period, women may be motivated to lose weight. Information aimed at promoting life style changes among overweight and obese women could in a longer perspective be integrated in the regular maternal health care in Sweden.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • prepregnant BMI 25-35
  • non smoking, single term birth
  • intention to breastfeed exclusively for 6 mo

排除标准

  • Diseases or medication in mother or child

结局指标

主要结局

Body weight

时间窗: 12 weeks

Weight loss after 12 weeks intervention

次要结局

  • body composition(12 weeks)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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