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临床试验/NCT01240499
NCT01240499已完成不适用

Intervention s'Inspirant du Nouveau Paradigme en matière de Gestion de Poids Chez Des Femmes préménopausées présentant un Surplus de Poids

Laval University1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2003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
144
试验地点
1
主要终点
Change in global health status outcomes (metabolic, psychological and nutritional variables, physical activity habits) from baseline to the end of the intervention, and at 6 and 12 months post-intervention.

研究概览

简要总结

The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts.

详细描述

Weight management is a critical issue in developed countries where the prevalence of obesity is increasing. Poor long-term success observed with current weight-control strategies stresses the relevance to explore new weight management approaches. One of these approaches, referred to as Health-At-Every-Size (HAES), is a new weight paradigm that focuses on a healthy lifestyle by promoting overall health benefits of behavioral changes related to dietary habits and physical activity and emphasizes self-acceptance and well-being, independently of body weight status. Studies on the effects of a HAES approach have shown significant improvements in metabolic and psychological variables.

To our knowledge, no study has yet reported the short and long-term impacts of a HAES approach on a cluster of variables (psychological, morphological, metabolic, and nutritional) in women. The aim of this study is to measure the effects of a HAES approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts. In this parallel controlled trial, women will be randomized to one of the 3 treatment conditions: HAES group, Social support group (SS), or Control group. Measurements will be taken in the short term as well as in the long term (up to 1 year post-intervention).

研究设计

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

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy premenopausal women from Quebec City metropolitan area
  • •Age: between 30 to 50 years old
  • •Stable body weight (+/- 2 kg) for at least 2 months before the beginning of the study
  • •Overweight or obesity: Body mass index [BMI] between 25 and 35 kg/m2
  • •Preoccupation about weight and eating: showing overconcern with shape and weight, exhibiting restriction over food choices for at least 2 years, and having been unsuccessful in previous attempts to lose weight (for at least the past 2 years)
  • •Current weight corresponding to maximum weight reached during adult lifetime

排除标准

  • •Women currently dieting to lose weight
  • •Taking oral contraceptives or postmenopausal status
  • •Pregnant or lactating women
  • •Under treatment for coronary heart disease, diabetes, dyslipidemia, hypertension, depression or endocrine disorders (with the exception of stable thyroid disease)
  • •Women presenting metabolic or important psychological disorders (drug or alcohol abuse, bulimia, ...)
  • •Women who had already take part to the Health-At-Every-Size (HAES) approach

研究组 & 干预措施

Health-At-Every-Size (HAES)

Experimental

干预措施: Health-At-Every-Size (HAES) (Other)

Social Support (SS)

Active Comparator

干预措施: Health-At-Every-Size (HAES) (Other)

Control

No Intervention

结局指标

主要结局

Change in global health status outcomes (metabolic, psychological and nutritional variables, physical activity habits) from baseline to the end of the intervention, and at 6 and 12 months post-intervention.

时间窗: At baseline and at the end of the intervention period (4 months), and at 6 months and 1 year post-intervention (10 months and 16 months, respectively).

Plasma LDL-cholesterol concentrations, Eating behaviors (restraint, disinhibition, and susceptibility to hunger), appetite ratings (desire to eat, hunger, fullness, and prospective food consumption), psychological variables (e.g. quality of life, self-esteem), physical activity habits, dietary intakes.

次要结局

  • Anthropometric and metabolic variables(At baseline and at the end of the intervention period (4 months), and at 6 months and 1 year post-intervention (10 months and 16 months, respectively).)

研究者

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

Simone Lemieux

Professeur

Laval University

研究点 (1)

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