Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-22 @ 9:55 AM
Study NCT ID:
NCT00644202
Status:
COMPLETED
Last Update Posted:
2008-03-26
First Post:
2008-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Weight Control Intervention at HPHC
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-20', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '24 weeks'}, {'measure': 'Diet', 'timeFrame': '24 weeks'}, {'measure': 'Physical activity', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['weight control'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine how adults can improve their physical activity levels and eating habits using an interactive web-based weight control program and regular contact with a dietician.', 'detailedDescription': '* All study participants must have regular access to the Internet, however, the study will not provide this access. Participants will be randomly placed in one of two study groups (Group 1 or Group 2).\n* Group 1 participants will be asked to make 3 in-person visits, each lasting 75-90 minutes. The following information will be collected: name, mailing address, telephone number, and email address. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.\n* Group 1 participants will also receive counseling around diet and physical activity from a registered dietician and be asked to use a specialized website that will allow them to track eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants.\n* Group 1 will also receive 5 telephone counseling calls with a health counselor. During the telephone calls, we will teach the participant new skills such as tracking diet and physical activity, goal-setting and staying motivated.\n* Group 2 participants will be asked to make 2 in-person visits, each lasting 75-90 minutes in length. The following information will be collected: your name, mailing address, and telephone number. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25 to 65 years of age\n* Body mass index between 30-40 kg/m2\n* Non-smoker (quit within previous 6 months)\n* Comfort reading and speaking English\n* Stage 1 hypertension\n* Not currently pregnant\n* Regular web access from home'}, 'identificationModule': {'nctId': 'NCT00644202', 'briefTitle': 'A Pilot Weight Control Intervention at HPHC', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Pilot Weight Control Intervention at Harvard Pilgrim Health Care (HPHC)', 'orgStudyIdInfo': {'id': '06-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Intervention Group', 'interventionNames': ['Behavioral: Counseling Sessions', 'Behavioral: Specialized Website', 'Behavioral: Telephone Counseling Calls']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2', 'description': 'Usual Care Group'}], 'interventions': [{'name': 'Counseling Sessions', 'type': 'BEHAVIORAL', 'description': 'Counseling Sessions at each study visit around diet and physical activity from a registered dietician', 'armGroupLabels': ['Group 1']}, {'name': 'Specialized Website', 'type': 'BEHAVIORAL', 'description': 'Specialized website that allows participants to track their eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants', 'armGroupLabels': ['Group 1']}, {'name': 'Telephone Counseling Calls', 'type': 'BEHAVIORAL', 'description': '5 telephone calls with a health counselor, lasting 15-20 minutes each.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Department of Ambulatory Care and Prevention', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gary Bennett, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Pilgrim Health Care', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gary Bennett, Ph.D', 'oldOrganization': 'Dana-Farber Cancer Institute'}}}}