Back to resultsA Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.
Primary Purpose
Breast Cancer, Body Weight Changes, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control group
Nutrition and physical activity group
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Institute for Health Research IdiPAZ
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Individual nutritional intervention.
Individual nutritional intervention with two groupal sessions and physical activity.
Outcomes
Primary Outcome Measures
To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.
To examine the frequency of food consumption
Secondary Outcome Measures
Full Information
NCT ID
NCT04980118
First Posted
September 12, 2019
Last Updated
July 18, 2021
Sponsor
Instituto de Investigación Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT04980118
Brief Title
A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.
Official Title
A Standardized Integral Nutritional Intervention 1 and Physical Activity Program
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Body Weight Changes, Weight Loss, Nutrition Related Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Individual nutritional intervention.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Individual nutritional intervention with two groupal sessions and physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
A nutritional intervention program that consisted of two individual nutritional consults.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and physical activity group
Intervention Description
A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.
Primary Outcome Measure Information:
Title
To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.
Description
To examine the frequency of food consumption
Time Frame
Six months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, Msc
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.
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