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临床试验/NCT02067481
NCT02067481已完成2 期

Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors

Institut Català d'Oncologia1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Weight loss

研究概览

简要总结

This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

详细描述

Aim:

The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.

Methods:

The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female patients from the Catalan Institute of Oncology
  • •Aged 18 to 75
  • •Body mass index (BMI) of 25 kg•m-2 or more
  • •Completed chemotherapy and/or radiotherapy for breast cancer during the 6 months preceding recruitment

排除标准

  • •First cancer, tumours of stage IIIB and above
  • •Morbid obesity (BMI ≥40 kg•m-2)
  • •Any condition that could not permit to follow the diet and PA intervention offered

研究组 & 干预措施

Single-arm weight loss intervention

Experimental

This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (AP) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment.

干预措施: Weight loss intervention (Behavioral)

结局指标

主要结局

Weight loss

时间窗: 3 months

Loss 3% of the initial weight

次要结局

  • Quality of life(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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