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临床试验/NCT01949558
NCT01949558已完成不适用

From Efficacy to Effectiveness: Randomized Controlled Trial of Lifestyle Intervention Postpartum Among Overweight and Obese Women Within Primary Health Care in the Vastra Gotaland Region

Göteborg University4 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年12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
发起方
入组人数
110
试验地点
4
主要终点
body weight

研究概览

简要总结

Chronic diseases such as overweight and cardiovascular diseases represent important threats to women's health. Pregnancy and lactation are associated with changes in weight, body composition and lipid metabolism and affect the risk of developing these chronic illnesses. Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese women's ability to make longterm lifestyle changes during the postpartum (pp) period, under ideal study conditions. Physiological mechanisms for weight reduction were investigated with precise methodology. However, effectiveness studies under different conditions are crucial for the development of effective programs for the Primary Health Care sector. Hence, the interest for translational research that brings results from clinical trials to the Primary Health Care sector has increased. The aim of this effectiveness-study is to investigate if dietary restrictions pp lead to significantly greater weight reduction among overweight/obese women, compared to no intervention, in a longterm perspective. In total 106 women will be recruited 10 wk pp and randomized into 1) control group; 2) dietary restrictions in individualized intervention during 12 wks. One and two years pp long term effects are evaluated. Positive results may be integrated into usual practice after the study ends.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • * BMI at 10 w postpartum >= 27.0

排除标准

  • *Serious disease in mother or child

研究组 & 干预措施

Control group

No Intervention

The control group receives a brochure on healthy dietary habits according to regular care.

Dietary intervention

Experimental

12 week individual intervention based on a cognitive behavioral approach. It includes dietary restriction under guidance by a dietitian. Thereafter monthly follow-up takes place via email during the following 9 mo.

干预措施: Dietary Intervention (Behavioral)

结局指标

主要结局

body weight

时间窗: 1 and 2 yrs post intervention start

次要结局

  • Cost-effectiveness(1 and 2 years post intervention start)

研究者

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

研究点 (4)

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