Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT01203995
Status:
COMPLETED
Last Update Posted:
2013-04-02
First Post:
2010-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Information Counseling for Elders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-29', 'studyFirstSubmitDate': '2010-09-01', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'two months'}], 'secondaryOutcomes': [{'measure': '2-Minute Step Test', 'timeFrame': 'two months', 'description': 'Number of steps completed in two minutes'}, {'measure': 'Chair stand test', 'timeFrame': '2 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 40 to 64 years.\n2. One or more CHC visits in the past 12 months.\n3. Body-mass index of ≥30 and \\<50.\n4. English speaking.\n5. Access to telephone.\n6. A permanent address.\n7. Willingness to be randomized.\n8. Willingness to have computer installed in home.\n\nExclusion Criteria:\n\n1. Any serious medical condition likely to hinder accurate weight measurement, or for which weight loss is contraindicated or could cause weight loss (e.g., cancer).\n2. Current diagnosis of psychosis or bipolar disorder.\n3. Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure\n4. Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis\n5. Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.\n6. Unwilling or unable to provide informed consent.\n7. Receiving disability insurance.\n8. Pregnant or nursing in past 6 months, or plans to become pregnant within 12 months.\n9. Enrolled in a weight loss program or study or member of household enrolled in study.\n10. Residence outside of Marion County, Indiana.\n11. Residence relocation plans within 12 months.\n12. Planned or prior bariatric surgery.\n13. Substance abuse.\n14. History of treatment for eating disorder.\n15. Unstable weight with loss or gain of ≥ 5% in last 3 months.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT01203995', 'acronym': 'RICE', 'briefTitle': 'Remote Information Counseling for Elders', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Remote Information Counseling for Elders', 'orgStudyIdInfo': {'id': '0710-65B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care'}, {'type': 'EXPERIMENTAL', 'label': 'brief nutrition education', 'interventionNames': ['Behavioral: Nutrition information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'In Center training', 'interventionNames': ['Behavioral: Nutrition education and exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Video Conference training', 'interventionNames': ['Behavioral: Nutrition education and exercise training']}], 'interventions': [{'name': 'Nutrition information', 'type': 'BEHAVIORAL', 'description': 'Brief nutrition education with take home reference materials and portion size tools', 'armGroupLabels': ['brief nutrition education']}, {'name': 'Nutrition education and exercise training', 'type': 'BEHAVIORAL', 'description': 'Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.', 'armGroupLabels': ['In Center training', 'Video Conference training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46205', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'HITS', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Daniel O Clark, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University Center for Aging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Kimberly Hemmerlein', 'investigatorAffiliation': 'Indiana University'}}}}