NCT04980118CompletedNot Applicable
A Standardized Integral Nutritional Intervention 1 and Physical Activity Program
Instituto de Investigación Hospital Universitario La Paz2 sites in 1 country56 target enrollmentStarted: April 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.
Study Overview
Brief Summary
To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.
Detailed Description
56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain.
A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Years: ≥18
- •Sex: Female
- •Newly diagnosed breast cáncer
Exclusion Criteria
- •Patients who have disseminated disease.
- •Associated eating behavior disorders.
- •Patients with dementia, mental illness or decreased cognitive function.
- •Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study).
- •Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism.
- •Pregnant or breastfeeding women.
Outcomes
Primary Outcomes
To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.
Time Frame: Six months
To examine the frequency of food consumption
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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