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

Sponsor
Instituto de Investigación Hospital Universitario La Paz (Other)
Overall Status
Completed
CT.gov ID
NCT04980118
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Control group
  • Behavioral: Nutrition and physical activity group
 N/A

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
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Standardized Integral Nutritional Intervention 1 and Physical Activity Program
Actual Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute for Health Research IdiPAZ Madrid Spain 28046

Sponsors and Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

Investigators

  • Principal Investigator: Carmen Gómez Candela, Msc, Hospital Universitario La Paz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT04980118
Other Study ID Numbers:
  • HULP 3114
First Posted:
Jul 28, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Body Weight
Weight Loss
Body Weight Changes

Study Results

No Results Posted as of Jul 28, 2021