Columbia University Medical Center
New York, 10032, United States
NCT Number: NCT01414062
The primary objectives of this study are to determine the effect of the dietary intervention (Cocinar para su salud! Program) vs. control (standard written nutrition education materials for cancer survivors) in Hispanic breast cancer survivors with early stage breast cancer on 1) daily servings of fruit and vegetable intake from baseline to 6 months; and 2) percent energy from fat and fat-related dietary habits from baseline to 6 months.
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Notify Me21 year and older
Female
Interventional
Not applicable
New York, 10032, United States
Hispanic women are 20% more likely to die of breast cancer than non Hispanic white women who are diagnosed at a similar age and stage. One reason for this disparity may be differences in post diagnosis dietary behaviors. In order to reduce this disparity, and to improve overall survivorship, culturally appropriate dietary interventions that teach women how to eat a diet high in fruits and vegetables and low in saturated fat need to be developed for Hispanic breast cancer survivors. The investigators propose to conduct a randomized controlled study (n=70, 35 per arm) to test the effects of the ¡Cocinar para su salud! program on changing dietary behaviors among Hispanic breast cancer survivors who have recently completed treatment. The ¡Cocinar para su salud! program is a 12 week course that provides hands on education and instruction in nutrition education, meal preparation, and food shopping in a group setting. All participants will be followed for a total of 12 months, have clinical assessments at baseline, 6 months, and 12 months, and monthly telephone contacts using motivational interview techniques.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
Other names: ¡Cocinar para su salud!
Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the New York City (NYC)-based not-for-profit, God's Love We Deliver
Time frame: Baseline and 6 months
The change in participants intake and fruits and vegetables at 6 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.
Time frame: Baseline and 12 months
The change in participants intake and fruits and vegetables at 12 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.
Time frame: Baseline and 12 months
Fasting blood will be collected at baseline and 12 months to determine whether the change in diet changes participants' biomarkers. Specifically, the change in DNA methylation (a chemical reaction in the body in which a small molecule called a methyl group gets added to DNA) will be measured against the increase in dietary factors.
Time frame: Baseline and 12 months
The change in weight from baseline to 12 months.
Time frame: Baseline and 12 months
The change in BMI from baseline to 12 months.
Columbia University
Other
Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors
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