Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-30 @ 12:38 AM
Study NCT ID:
NCT00884195
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2009-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Journaling and Weight Loss
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2009-04-17', 'studyFirstSubmitQcDate': '2009-04-17', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '3 months'}, {'measure': 'Class attendance', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "This is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome of a weight loss program. All the subjects will be enrolled in the Lifesteps weight management program. The experimental group will maintain a gratitude journal and the control group will maintain a 'neutral' journal.", 'detailedDescription': 'Subjects who are referred to the Preventive Cardiology Program for weight management will be enrolled in the study after obtaining informed consent.\n\nSubjects are enrolled into the program in groups of 10 to 12 every 6 weeks. Alternate groups will be will assigned to the two types of journaling. Each group will be given specific instructions related to the form of journaling assigned. These instructions will be in addition to the usual care prescribed in the Lifesteps® program. In the intervention group, patients will be introduced to gratitude journaling at the beginning of the 12 week class series and asked to journal each day. They will turn in their gratitude journal weekly. At the beginning of each weekly class, five minutes will be spent discussing the journaling.\n\nThe control groups will not receive the information on gratitude journaling, but instead will be asked to complete a neutral journal in which they will journal in a general manner regarding their experiences participating in the Lifesteps® weight management program. These will also be collected weekly. At the beginning of class, five minutes will be spent discussing the journaling.\n\nThere will be one consent form for the two groups. The instruction (either gratitude journaling or neutral journaling) that will be given to the subjects will reflect the group to which they have been randomized. Both types of journals will be reviewed initially, at mid-point and final by the psychologist (Robert Emmons) to verify the quality of reporting.\n\nRoutine tests- Weekly weights\n\nStudy Tests:\n\nPre/post depression: Beck Depression Inventory II; Pre/post Locus of Control: Multidimensional Health Locus of Control Scale; Pre/post SF 36 Quality of Life Questionnaire; Pre/post Gratitude Questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>25\n* \\>18 years of age\n\nExclusion Criteria:\n\n* Severe psychiatric diagnosis which in the opinion of the PI would compromise participation in the study.\n* Addiction to alcohol and drugs'}, 'identificationModule': {'nctId': 'NCT00884195', 'briefTitle': 'Journaling and Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Journaling and Weight Loss', 'orgStudyIdInfo': {'id': '200816667'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Gratitude Journaling', 'interventionNames': ['Behavioral: Gratitude Journaling']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Neutral Journaling', 'interventionNames': ['Behavioral: Neutral Journaling']}], 'interventions': [{'name': 'Gratitude Journaling', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to write down 5 things every day for which they are grateful.', 'armGroupLabels': ['1']}, {'name': 'Neutral Journaling', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'CT Kappagoda, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}