Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT01846169
Status:
COMPLETED
Last Update Posted:
2014-08-25
First Post:
2013-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Improve Healthy Eating for At-Risk Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2013-05-01', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body composition', 'timeFrame': '6 months', 'description': 'percent body fat'}, {'measure': 'BMI', 'timeFrame': '6 months', 'description': 'Body mass index'}, {'measure': 'weight', 'timeFrame': '6 months', 'description': 'total body weight in pounds'}, {'measure': 'blood pressure', 'timeFrame': '6 months', 'description': 'systolic and diastolic blood pressure'}, {'measure': 'blood glucose', 'timeFrame': '6 months', 'description': 'measurement of blood glucose'}], 'secondaryOutcomes': [{'measure': 'nutritional risk', 'timeFrame': '6 months', 'description': 'food frequency questionnaire assessing levels of food intake in pre-specified categories (e.g., fruits and vegetables)'}, {'measure': 'food insecurity', 'timeFrame': '6 months', 'description': 'measurement of food insecurity as assessed by standard questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['food insecurity', 'older adults', 'nutrition', 'food deliveries'], 'conditions': ['Biometrics']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aarp.org/aarp-foundation/', 'label': 'AARP Foundation'}]}, 'descriptionModule': {'briefSummary': 'This application, funded by the American Association of Retired Persons(AARP) Foundation, is to implement the Healthy Eating for at Risk Older Adults (HERO) initiative. This initiative will address barriers of affordability, and reduced mobility by providing older adults with nutritious foods that are usually difficult to purchase due to high cost; delivering needed foods to individuals in their homes; tailoring food delivery frequency based on level of food insecurity; and offering basic nutrition education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 55 years old or older\n* if member of Boston Medical Center's Elders Living at Home Program: Not currently homeless and expect to live at current residence or in the area for next 6 months\n* if NOT member of Boston Medical Center's Elders Living at Home Program: Not currently homeless, live at public housing development, and plan to live there for at least next 6 months\n* Able to understand, speak and read English\n\nExclusion Criteria:\n\n* Follows a special diet that cannot be accommodated, as ascertained by clinical judgment of the nurse."}, 'identificationModule': {'nctId': 'NCT01846169', 'briefTitle': 'Study to Improve Healthy Eating for At-Risk Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Healthy Eating for At-Risk Older Adults (HERO)', 'orgStudyIdInfo': {'id': 'HUN-12-2011-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'food deliveries', 'description': 'After baseline screening, participants receive weekly or bi-weekly food deliveries and brief nutrition education.', 'interventionNames': ['Behavioral: Food deliveries']}], 'interventions': [{'name': 'Food deliveries', 'type': 'BEHAVIORAL', 'description': 'Frequency of food deliveries is based on level of food insecurity at baseline (i.e., more food insecurity receives more frequent food deliveries). Deliveries are tailored to the diet of the client (e.g., consist of soft foods if participant has trouble chewing; has more fruits and vegetables if that was a food category the participant at less of at baseline). The brief nutrition education is a review of basic nutrition concepts and healthy eating ideas.', 'armGroupLabels': ['food deliveries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': "Eileen O'Brien", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}