Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-29 @ 8:18 AM
Study NCT ID:
NCT03999892
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adapted ACHIEVE Curriculum for Community Mental Health Settings
Sponsor:
Organization:
Raw JSON
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Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Serious Mental Illness Satisfaction With ACHIEVE Curriculum as Assessed by a Yes Response to Two Questions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Serious Mental Illness', 'description': 'Consumers with serious mental illness who attend a psychiatric rehabilitation program will participate in a pilot test of group-based weight management program modules.'}], 'classes': [{'title': 'Would want to continue with the ACHIEVE Program', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Would recommend the ACHIEVE program to other clients who want to lose weight', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One week post-intervention', 'description': 'Two questions during focus group:\n\n* Would want to continue with the ACHIEVE Program (Yes/No)\n* Would recommend the ACHIEVE program to other clients who want to lose weight (Yes/No)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants did not respond'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Consumers With SMI', 'description': 'Consumers with serious mental illness who attend a psychiatric rehabilitation program (PRP) will participate in a group-based diet and physical activity program.\n\nACHIEVE: The investigators will test two modules of the adapted video-assisted curriculum format of 45 to 60-minute multipurpose classes, which will include a segment on group weight management (\\~20-30 minutes) and group exercise (\\~20-30 minutes). Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Serious Mental Illness', 'description': 'Consumers with serious mental illness who attend a psychiatric rehabilitation program'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-13', 'size': 244385, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-12T08:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-12', 'studyFirstSubmitDate': '2019-06-25', 'resultsFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-12', 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Serious Mental Illness Satisfaction With ACHIEVE Curriculum as Assessed by a Yes Response to Two Questions', 'timeFrame': 'One week post-intervention', 'description': 'Two questions during focus group:\n\n* Would want to continue with the ACHIEVE Program (Yes/No)\n* Would recommend the ACHIEVE program to other clients who want to lose weight (Yes/No)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Mental Disorders, Severe']}, 'referencesModule': {'references': [{'pmid': '23517118', 'type': 'BACKGROUND', 'citation': 'Daumit GL, Dickerson FB, Wang NY, Dalcin A, Jerome GJ, Anderson CA, Young DR, Frick KD, Yu A, Gennusa JV 3rd, Oefinger M, Crum RM, Charleston J, Casagrande SS, Guallar E, Goldberg RW, Campbell LM, Appel LJ. A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med. 2013 Apr 25;368(17):1594-602. doi: 10.1056/NEJMoa1214530. Epub 2013 Mar 21.'}]}, 'descriptionModule': {'briefSummary': "In light of the obesity epidemic in persons with serious mental illness (SMI), there is an urgent need to scale-up behavioral interventions that have demonstrated efficacy in the clinical trial setting such as the intervention in the National Institute of Mental Health (NIMH)-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders.", 'detailedDescription': "Prevalence of obesity is significantly elevated and a leading cause of preventable death in people with serious mental illness (SMI) through its effects on other cardiovascular disease (CVD) risk factors and CVD. Behavioral interventions targeting changes in diet and exercise need to be tailored to the needs of people with SMI, such as memory impairment and limited executive function. The NIMH-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial tested a behavioral weight-loss intervention for persons with SMI and demonstrated clinically significant weight loss. In light of the obesity epidemic in persons with SMI, there is an urgent need to scale-up interventions like ACHIEVE. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 or older\n* consumers at Prologue psychiatric rehabilitation program\n* expected to be in the rehabilitation program for at least 6 months after enrollment\n* able to attend the intervention classes 3 days per week\n* able and willing to give informed consent and participate in the intervention\n* have a body mass index (BMI) over 25 kg/m2\n* be interested in losing weight\n\nExclusion Criteria:\n\n* any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the study, or for which dietary change or physical activity may be contraindicated and/or require medical supervision by a physician (e.g., medication-dependent diabetes mellitus, cancer or malignant tumor, lung disease requiring supplemental oxygen, dementia or cognitive impairment, consumption of more than 14 drinks per week, eating disorders, angina, or diagnosis in the last 12 months of myocardial infarction, congestive heart failure, transient ischemic attack or stroke, liver disease or kidney disease)\n* women who are pregnant or breastfeeding\n* individuals with an inability to walk to participate in exercise class as demonstrated by walking up and down 2 flights of stairs'}, 'identificationModule': {'nctId': 'NCT03999892', 'briefTitle': 'Adapted ACHIEVE Curriculum for Community Mental Health Settings', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'ACHIEVE-D Pilot Study', 'orgStudyIdInfo': {'id': 'IRB00194122'}, 'secondaryIdInfos': [{'id': 'P50MH115842', 'link': 'https://reporter.nih.gov/quickSearch/P50MH115842', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilot weight management module', 'description': 'Consumers with serious mental illness who attend a psychiatric rehabilitation program will participate in a pilot of modules of a group-based diet and physical activity program. Staff/ peer leaders a psychiatric rehabilitation program will observe sessions.', 'interventionNames': ['Behavioral: ACHIEVE']}], 'interventions': [{'name': 'ACHIEVE', 'type': 'BEHAVIORAL', 'description': 'The investigators will test two modules of the adapted video-assisted curriculum format of 45 to 60-minute multipurpose classes, which will include a segment on group weight management (\\~20-30 minutes) and group exercise (\\~20-30 minutes). Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum.', 'armGroupLabels': ['Pilot weight management module']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Gail Daumit', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}