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

NCT ID: NCT04980118

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer Body Weight Changes Weight Loss Nutrition Related Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Individual nutritional intervention.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type BEHAVIORAL

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

Experimental group

Individual nutritional intervention with two groupal sessions and physical activity.

Group Type EXPERIMENTAL

Nutrition and physical activity group

Intervention Type BEHAVIORAL

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

Interventions

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Control group

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Gómez Candela, Msc

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

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Institute for Health Research IdiPAZ

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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HULP 3114

Identifier Type: -

Identifier Source: org_study_id

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