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临床试验/NCT00513084
NCT00513084Unknown不适用

Moderators and Mediators of Physical Activity, Body Weight, and Body Composition Change During Obesity Treatment in Women

Technical University of Lisbon2 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2004年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
259
试验地点
2
主要终点
Primary outcomes are physical activity/exercise and body weight/ composition. Physical activity is assessed by accelerometry and standardized interview/questionnaire methods. Body composition is assessed by DXA

研究概览

简要总结

The primary objectives of this randomized clinical trial are a) to implement and test the impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on 3-year change in physical activity and motivation for exercise/physical activity, body weight and fat, and selected eating variables, b) to identify behavioral and psychosocial theory-based moderators or mediators of primary outcomes, especially physical activity and body weight.

详细描述

Obesity and sedentary lifestyles are worldwide threats to public health but feasible and effective strategies to tackle these problems are scarce. The identification of variables that explain why only a sub-group of overweight persons succeeds at increasing physical activity and achieving long-term weight control is a key research topic in exercise and sports sciences. Subjects are 260 healthy women (BMI, 25 to 40 kg/m2), aged between 25 and 50 years, premenopausal, of whom half receive the treatment intervention, the remaining being randomly assigned to a control group at baseline. This RCT consists of a 1-year intervention plus a 2-year no contact follow-up period. The intervention group attended 30 weekly group sessions, designed to follow SDT basic tenets, covering PA, eating/nutrition, body image, and other cognitive and behavioral contents. Central to the intervention model are autonomy, intrinsic motivation, and self-regulation of behavior change. Autonomy-supportive treatment climate and internal causality orientations are predicted to enhance autonomous regulation, perceived competence, and intrinsic motivation for the targeted behaviors, resulting in lasting behavioral and body weight changes. The intervention was designed to follow SDT, with an emphasis on promoting intrinsic, self-regulated motivation for exercise and weight control. The control group received a general health education curriculum based on several 3- to 6-week long educational topics (e.g. food safety, stress management, self-care, body image, and others). Results are expected to contribute to a better understanding of how individual characteristics, particularly those related to physical activity and exercise influence success, better screening/readiness testing procedures, improved matching of interventions to participants, and lower rates of attrition and unsuccessful weight loss attempts.

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
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • female (25-50 years old)
  • pre-menopausal
  • BMI between 25 and 40 kg/m2
  • willing to attend weekly meetings (during 1 year)
  • willing to not participate in other formal or informal weight loss program during the first year of the study (intervention group only).

排除标准

  • major/chronic illness
  • taking (or having taken in the previous year) medication known to interfere with body weight regulation, including anti-depressive medication

结局指标

主要结局

Primary outcomes are physical activity/exercise and body weight/ composition. Physical activity is assessed by accelerometry and standardized interview/questionnaire methods. Body composition is assessed by DXA

时间窗: baseline, 4, 12, 16, 24 and 36 months

次要结局

  • Dietary Intake, psychosocial SDT-based mediators(baseline, 4, 12,16, 24 and 36 months)

研究者

发起方
Technical University of Lisbon
申办方类型
Other

研究点 (2)

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