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

NCT04980118 | Completed

• 1 other identifier: HULP 3114
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Body Weight Changes; Weight Loss; Nutrition Related Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Six months

Study Arms (2)

Control group

PLACEBO COMPARATOR

Individual nutritional intervention.

Behavioral: Control group

Experimental group

EXPERIMENTAL

Individual nutritional intervention with two groupal sessions and physical activity.

Behavioral: Nutrition and physical activity group

Interventions

Control group BEHAVIORAL

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

Control group

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years: ≥18
• Sex: Female
• Newly diagnosed breast cáncer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Body Weight Changes; Weight Loss

Interventions

Control Groups; Nutritional Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Carmen Gómez Candela, Msc

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: July 28, 2021
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2012
• Last Updated: July 28, 2021

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)