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临床试验/NCT06577545
NCT06577545尚未招募不适用

Design, Implementation and Evaluation of a Behavioural Intervention to Treat Obesity in Breast Cancer Survivors.

University of Thessaly2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2026年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
92
试验地点
2
主要终点
body weight change

研究概览

简要总结

The goal of this clinical trial is to compare a behavioural lifestyle intervention program (BL) to usual care (UC) in breast cancer survivors. The main questions it aims to answer are:

  1. If the participants of the BL group will lose more weight than the UC group.
  2. If the participants of the BL group will have more lifestyle benefits than the UC group.

Volunteers will participate in a 24-week behavioural program. This program aims to improve their nutrition and physical activity in order to lose at least 10% of their initial body weight.

详细描述

Eligible participants should be female breast cancer survivors between the ages of 18 and 65, with a BMI between 25 and 40 kg/m2, and no active cancer therapy or ongoing treatment, except for hormonal or immune therapy.

The usual care (UC) group will receive WCRF cancer prevention recommendations. The behavioural lifestyle intervention program (BL) group will participate in a 24-week intervention targeting diet and physical activity to lose weight.

The program will be considered successful if participants lose at least 10% of their initial body weight. A secondary goal is to improve their nutrition and physical activity levels. The third and last goal is to improve their overall quality of life and their anxiety levels.

The behavioral program includes in-person online meetings, group online sessions, and digital counseling material. Considering that participants will be residing all around Greece, an internet videoconferencing technology will be required.

A qualitative study incorporating focus groups undertaken prior to this study to establish the methodology resulted in the utilization of synchronous and asynchronous media, as well as a combination of in-person and group sessions.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI between 25 and 40 kg/m2

排除标准

  • active cancer or any ongoing treatment except hormonal or immune therapy

结局指标

主要结局

body weight change

时间窗: From enrollment to the end of treatment at 24 weeks

% of the initial body weight change

次要结局

未报告次要终点

研究者

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

Odysseas Androutsos

Professor of Nutrition and Clinical Dietetics, Department of Nutrition and Dietetics

University of Thessaly

研究点 (2)

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