Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT00323193
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2006-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Using MOVE! With Seriously Mentally Ill Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.goldberg@va.gov', 'phone': '410-637-1851', 'title': 'Richard W. Goldberg, Ph.D.', 'organization': 'VA VISN 5 Mental Illness Research, Education and Clinical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse Events were reviewed for this study, although none were observed during the research trial.', 'eventGroups': [{'id': 'EG000', 'title': 'MOVE Group', 'description': 'The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.\n\nMOVE!: group based psychoeducation, motivation and support', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The control condition offers basic information about diet and exercise on a monthly basis.', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE Group', 'description': 'The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.\n\nMOVE!: group based psychoeducation, motivation and support'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The control group offers basic information about diet and exercise every month for six months.'}], 'classes': [{'title': 'Baseline Weight', 'categories': [{'measurements': [{'value': '237.2', 'spread': '50.3', 'groupId': 'OG000'}, {'value': '230.2', 'spread': '45.7', 'groupId': 'OG001'}]}]}, {'title': '6 Month follow up', 'categories': [{'measurements': [{'value': '240.8', 'spread': '40.1', 'groupId': 'OG000'}, {'value': '228.1', 'spread': '43.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.720', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six months', 'description': 'Weight taken at the baseline assessment and again at the 6 month assessment', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Impact of Weight on Quality of Life Survey (IWQOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE Group', 'description': 'The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.\n\nMOVE!: group based psychoeducation, motivation and support'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The control group offers basic information about diet and exercise every month for six months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67.6', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '73.5', 'spread': '21.4', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow up', 'categories': [{'measurements': [{'value': '75.1', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.710', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six months', 'description': 'Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MOVE Group', 'description': 'The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.\n\nMOVE!: group based psychoeducation, motivation and support'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The control group offers basic information about diet and exercise every month for six months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MOVE Group', 'description': 'The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.\n\nMOVE!: group based psychoeducation, motivation and support'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The control condition offers basic information about diet and exercise on a monthly basis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-06', 'studyFirstSubmitDate': '2006-05-05', 'resultsFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2006-05-08', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-06', 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Measurement', 'timeFrame': 'baseline and six months', 'description': 'Weight taken at the baseline assessment and again at the 6 month assessment'}], 'secondaryOutcomes': [{'measure': 'Impact of Weight on Quality of Life Survey (IWQOL)', 'timeFrame': 'baseline and six months', 'description': 'Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Behavioral interventions', 'Mental Illness', 'Obesity', 'Psycho-educational interventions', 'Weight management'], 'conditions': ['Mental Illness', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '23584716', 'type': 'RESULT', 'citation': 'Goldberg RW, Reeves G, Tapscott S, Medoff D, Dickerson F, Goldberg AP, Ryan AS, Fang LJ, Dixon LB. "MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. Psychiatr Serv. 2013 Aug 1;64(8):737-44. doi: 10.1176/appi.ps.201200314.'}]}, 'descriptionModule': {'briefSummary': 'This study involves a controlled trial of an optimized version of a weight management and physical activity psycho-educational intervention (called MOVE!) with 200 obese and overweight veterans with serious mental illness.', 'detailedDescription': 'This study involves a controlled trial of an optimized version of a weight management and physical activity psycho-educational intervention (called MOVE!) for overweight and obese Veterans with serious mental illness. The study hypothesizes that MOVE! will result in weight loss and improved indicators of cardiovascular risk when compared to usual care. Medical outcomes are proportion achieving 4% or higher weight loss, mean weight loss, and reductions in cardiovascular risk (blood pressure, glucose and serum lipids). Psychosocial outcomes are general health, psychiatric functioning, quality of life, and self-esteem and medication adherence. Mediators include physical activity, dietary management, self-efficacy, and motivation/readiness to change. The intervention involves a well specified combination of individualized and group based services and draws on evidence based techniques and materials that are currently well packaged in an existing VA program called MOVE! The Comparison condition is operationalized as usual treatment plus monthly weight measurements and distribution of educational brochures regarding diet and exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM- IV diagnosis of schizophrenia spectrum disorders OR a DSM-IV diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder;\n* Age between 18-64;\n* No psychiatric hospitalization in 3-month period prior to enrollment;\n* Community residency within 30 miles of either VA facility;\n* A BMI of 25 or higher;\n* Voluntary consent after receiving full information about the study;\n* English speaking;\n* Veteran of the armed forces\n\nExclusion Criteria:\n\n* Active cancer other than non-melanoma skin cancer\n* end stage chronic obstructive pulmonary disease\n* end stage congestive heart failure\n* end-stage neurological disorder\n* problematic substance abuse as defined by provider\n* end stage renal disease\n* moderate to severe cognitive impairment (dementia, post-stroke)\n* HIV positive with a CD4 count less than or equal to 350 within the last 6 months\n* anorexia\n* current pregnancy, currently nursing or planning to become pregnant in the next 6 months\n* those living in long-term care facilities\n* use in past 3 months of prescription pharmacological agents for weight loss\n* no chart documented VA delivered medical primary care or general somatic care visit within the last 18 months\n* most recent chart documented hematocrit level obtained within last six months is at or below 30%\n* most recent chart documented creatinine level obtained within the last six months that is at or above 2.5\n* most recent chart documented liver function tests obtained within the last six months exceeds twice the normal value for ALT, AST test in the Baltimore VA laboratory'}, 'identificationModule': {'nctId': 'NCT00323193', 'briefTitle': 'Using MOVE! With Seriously Mentally Ill Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Using MOVE! With Seriously Mentally Ill Veterans', 'orgStudyIdInfo': {'id': 'D4219-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.', 'interventionNames': ['Behavioral: MOVE!']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2', 'description': 'The control group offers basic information about diet and exercise every month for six months.'}], 'interventions': [{'name': 'MOVE!', 'type': 'BEHAVIORAL', 'description': 'group based psychoeducation, motivation and support', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'VA Maryland Health Care System, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Richard W Goldberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Maryland Health Care System, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}