Comprehensive Lifestyle Change To Prevent Breast Cancer
- Conditions
- Premenopausal
- Registration Number
- NCT03448003
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Able to read, write, and speak English<br><br> - Premenopausal<br><br> - A body mass index (BMI) >= 25<br><br> - Have intact breasts and ovaries<br><br> - Able to provide informed consent to participate in the study<br><br> - Meet all the following criteria related to lifestyle: a) consume less than 3<br> servings of vegetables (excluding any fried servings) and 1 serving of fruit (not<br> including juice)/day; b) engage in less than 150 minutes moderate/vigorous intensity<br> activity per week, defined as anything that causes small increases in breathing or<br> heart rate for a sustained amount of time (e.g., brisk walking, bicycling); c)<br> engage in a mind-body practice less once per week<br><br> - Able mentally and physically to participate in interventions in this study (Note: If<br> there are one or more positive responses to the Physical Activity Readiness<br> Questionnaire [PARQ], then a physician-release for exercise is required prior to<br> obtaining consent)<br><br> - Access to internet connection<br><br> - Able to come to University of Texas (UT) MD Anderson for the orientation and<br> assessment sessions<br><br>Exclusion Criteria:<br><br> - Any personal history of cancer, including ductal carcinoma in situ (DCIS) and not<br> including non-melanoma skin cancers<br><br> - Any major thought disorder (e.g., schizophrenia, dementia)<br><br> - Communication barriers (e.g. hard of hearing)<br><br> - Poorly or uncontrolled diabetes in the opinion of the physician(s)<br><br> - Being pregnant or planning on becoming pregnant within the next year<br><br> - Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention<br> for breast cancer prevention within the next year (Note: Individuals taking<br> tamoxifen, arimidex or other hormonal prevention strategies at time of consent will<br> be eligible)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Consent rate;Treatment group compliance rate;Retention rate
- Secondary Outcome Measures
Name Time Method Group differences over time in biological pathways;Group differences over time in dietary patterns;Group differences over time in fitness levels;Group differences over time in percent body fat;Group differences over time in anthropometrics;Gut microbiome