A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.

Not Applicable

Completed

• Conditions: Weight Loss; Nutrition Related Cancer; Breast Cancer; Body Weight Changes
• Interventions: Behavioral: Control group; Behavioral: Nutrition and physical activity group

• Registration Number: NCT04980118
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2011-04
• Study Completion: 2012-04
• Status Verified: 2019-08
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2021-07-18
• Last Update Submitted: 2021-07-18
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Individual nutritional intervention.
Experimental group	Nutrition and physical activity group	Individual nutritional intervention with two groupal sessions and physical activity.

Primary Outcome Measures

Name	Time	Method
To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.	Six months	To examine the frequency of food consumption

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain