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临床试验/CTRI/2024/11/076490
CTRI/2024/11/076490尚未招募不适用

Effectiveness of Interventional package on modifiable risk factors of breast cancer among high risk women-Randomized control trial

Catherine K1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
220
试验地点
1
主要终点
changes in the modifiable risk factors of breast cancer ( level of lifestyle practices, 24 hours dietary pattern and clinical parameters) among high risk women

研究概览

简要总结

After obtaining formal permission from medical officer in the concerned rural area,  women between 30-45 years will be screened for high risk category by Snehita brisk model (online calculator).women fulfilling the inclusion criteria will be selected and informed consent will be obtained. women in the control group will follow routine practice and experimental group will be given package of interventions for 9 months. Pre-test on level of awareness, level of lifestyle practices, 24 hours dietary recall and Clinical parameters ( SBP, DBP, height, weight, BMI, Body composition- body fat, visceral fat, skeletal muscle, WhtR, Fasting Blood glucose and serum Estradiol will be done for  both the groups.

The interventions include

  1. Information Education Communication IEC on Breast cancer by teaching sessions (PPT) and training sessions on practice of Breast self examination (Breast model)

  2. Nutritional Education using flash cards

  3. Phytoestrogen diet -Soya beans 5 grams daily - 5 days per week . It will be provided by the researcher. It has to be soaked previous day night and has to be consumed next day morning after breakfast

4.Exercise - Moderate intensity brisk walking for 3 days in a week for about 60 minutes per session starting and ending with warm up exercises

  1. Mindfulness therapy - must practice 3 days in a week for about 20 minutes as taught by the researcher

Post test will be done at the end of  3rd month, 6th month and 9th month

Post test on Serum estradiol alone will be done at the end of the study

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • High risk for breast cancer according to Snehita Breast cancer risk calculator tool Age group of 30-45 years Regular menstrual cycle Obese and Overweight as per WHO BMI.

排除标准

  • Women with personal history of any cancer at present or treated earlier History of allergy to soya beans Hypothyroidism ( Soya can interfere with absorption of thyroid medication ).

结局指标

主要结局

changes in the modifiable risk factors of breast cancer ( level of lifestyle practices, 24 hours dietary pattern and clinical parameters) among high risk women

时间窗: At baseline | end of 3rd month | end of 6th month | end of 9th month

次要结局

  • Changes in the level of awareness among high risk women

研究者

发起方
Catherine K
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Catherine K

College of Nursing Pondicherry Institute of Medical Sciences

研究点 (1)

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