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Completed

NCT Number: NCT04980118

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

To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.

Completed

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Key information

Conditions

Breast Cancer Body Weight Body Weight Changes Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Related Cancer Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Weight Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Behavioral

A nutritional intervention program that consisted of two individual nutritional consults.

Nutrition and physical activity group

Behavioral

A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

A Standardized Integral Nutritional Intervention 1 and Physical Activity Program

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 28, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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