Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-02 @ 11:19 AM
Study NCT ID:
NCT00158366
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2005-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing the Weight of Overweight Schizophrenia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight reduction', 'timeFrame': 'Measured at Week 14 and Month 24'}], 'secondaryOutcomes': [{'measure': 'Weight maintenance', 'timeFrame': 'Measured at Week 14 and Month 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Weight Loss'], 'conditions': ['Schizophrenia', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '15705006', 'type': 'BACKGROUND', 'citation': 'Brar JS, Ganguli R, Pandina G, Turkoz I, Berry S, Mahmoud R. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2005 Feb;66(2):205-12. doi: 10.4088/jcp.v66n0208.'}, {'pmid': '11356587', 'type': 'BACKGROUND', 'citation': 'Ganguli R, Brar JS, Ayrton Z. Weight gain over 4 months in schizophrenia patients: a comparison of olanzapine and risperidone. Schizophr Res. 2001 Apr 30;49(3):261-7. doi: 10.1016/s0920-9964(00)00080-3.'}, {'pmid': '10548138', 'type': 'BACKGROUND', 'citation': 'Ganguli R. Weight gain associated with antipsychotic drugs. J Clin Psychiatry. 1999;60 Suppl 21:20-4.'}, {'pmid': '23410710', 'type': 'DERIVED', 'citation': 'Janney CA, Ganguli R, Richardson CR, Holleman RG, Tang G, Cauley JA, Kriska AM. Sedentary behavior and psychiatric symptoms in overweight and obese adults with schizophrenia and schizoaffective disorders (WAIST Study). Schizophr Res. 2013 Apr;145(1-3):63-8. doi: 10.1016/j.schres.2013.01.010. Epub 2013 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.', 'detailedDescription': "Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population.\n\nThis study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia or schizoaffective disorder\n* Body mass index (BMI) greater than 27\n* Stable on antipsychotic drug regimen for at least 1 month prior to study entry\n* Parent or guardian willing to provide informed consent, if applicable\n* Positive and negative syndrome scale score less than 90\n* Willing to use acceptable methods of contraception during the study\n\nExclusion Criteria:\n\n* Medical contraindication for participating in a weight reduction/exercise program\n* Mental retardation\n* Current enrollment in another weight management program\n* Current use of weight reduction medication\n* Unstable cardiovascular or thyroid disease\n* Active or end-stage renal disease\n* Psychiatric hospitalization within 1 month prior to study entry\n* Current use of more than one anti-psychotic medication\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00158366', 'briefTitle': 'Reducing the Weight of Overweight Schizophrenia Patients', 'nctIdAliases': ['NCT00177905'], 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Clinical Trial Of Weight Reduction in Schizophrenia', 'orgStudyIdInfo': {'id': 'R01MH066068', 'link': 'https://reporter.nih.gov/quickSearch/R01MH066068', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH066068', 'link': 'https://reporter.nih.gov/quickSearch/R01MH066068', 'type': 'NIH'}, {'id': 'DSIR 83-ATAP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Phase 1 participants who will receive behavioral training for 14 weeks', 'interventionNames': ['Behavioral: Behavioral training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Phase 1 participants who will receive social skills training for 14 weeks', 'interventionNames': ['Behavioral: Social skills training']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2', 'interventionNames': ['Behavioral: Behavioral training']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2', 'interventionNames': ['Behavioral: Behavioral training booster sessions']}], 'interventions': [{'name': 'Behavioral training', 'type': 'BEHAVIORAL', 'description': 'The behavioral training will teach participants ways to control their diet and increase their physical activity.', 'armGroupLabels': ['1', '3']}, {'name': 'Social skills training', 'type': 'BEHAVIORAL', 'description': 'The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.', 'armGroupLabels': ['2']}, {'name': 'Behavioral training booster sessions', 'type': 'BEHAVIORAL', 'description': "During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.", 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Rohan Ganguli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Rohan Ganguli', 'investigatorAffiliation': 'University of Pittsburgh'}}}}