Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04980118
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2019-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-18', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2021-07-18', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.', 'timeFrame': 'Six months', 'description': 'To examine the frequency of food consumption'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Body Weight Changes', 'Weight Loss', 'Nutrition Related Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.', 'detailedDescription': '56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain.\n\nA 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Years: ≥18\n* Sex: Female\n* Newly diagnosed breast cáncer\n\nExclusion Criteria:\n\n* Patients who have disseminated disease.\n* Associated eating behavior disorders.\n* Patients with dementia, mental illness or decreased cognitive function.\n* Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study).\n* Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism.\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT04980118', 'briefTitle': 'A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'A Standardized Integral Nutritional Intervention 1 and Physical Activity Program', 'orgStudyIdInfo': {'id': 'HULP 3114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Individual nutritional intervention.', 'interventionNames': ['Behavioral: Control group']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Individual nutritional intervention with two groupal sessions and physical activity.', 'interventionNames': ['Behavioral: Nutrition and physical activity group']}], 'interventions': [{'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'A nutritional intervention program that consisted of two individual nutritional consults.', 'armGroupLabels': ['Control group']}, {'name': 'Nutrition and physical activity group', 'type': 'BEHAVIORAL', 'description': 'A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Institute for Health Research IdiPAZ', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carmen Gómez Candela, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}