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

July 18, 2021 updated by: Instituto de Investigación Hospital Universitario La Paz

A Standardized Integral Nutritional Intervention 1 and Physical Activity Program

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Institute for Health Research IdiPAZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Individual nutritional intervention.
Behavioral: Control group
A nutritional intervention program that consisted of two individual nutritional consults.
Experimental: Experimental group
Individual nutritional intervention with two groupal sessions and physical activity.
Behavioral: Nutrition and physical activity group
A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 12, 2019

First Submitted That Met QC Criteria

July 18, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 18, 2021

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP 3114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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