Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT01377506
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2011-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Translation of Obesity and Cognitive Program by Lay Health Educators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'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': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2011-06-17', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '4 and 12 month', 'description': 'weight change from baseline in kg and percent weight loss \\[1-(12-month weight/baseline weight)'}], 'secondaryOutcomes': [{'measure': 'cognitive function', 'timeFrame': '4 and 12 month', 'description': 'change in memory (immediate and delayed) and attention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['behavioral weight control', 'lifestyle intervention', 'memory training', 'cognitive training', 'community-based'], 'conditions': ['Overweight', 'Memory Disorder']}, 'referencesModule': {'references': [{'pmid': '21961465', 'type': 'DERIVED', 'citation': 'West DS, Bursac Z, Cornell CE, Felix HC, Fausett JK, Krukowski RA, Lensing S, Love SJ, Prewitt TE, Beck C. Lay health educators translate a weight-loss intervention in senior centers: a randomized controlled trial. Am J Prev Med. 2011 Oct;41(4):385-91. doi: 10.1016/j.amepre.2011.06.041.'}]}, 'descriptionModule': {'briefSummary': "Obesity is a major public health problem among older adults, with 31% of non-institutionalized older persons (60 years+) in the US obese and projections indicating that this will rise to 40% by 2010. A second public health challenge on the horizon for the aging US population is the increasing number of individuals experiencing cognitive decline, dementia or Alzheimer 's disease. Recent clinical trials have demonstrated efficacy in reducing risks associated with both of these significant and increasingly pervasive health problems, which are more common among rural, low income and ethnic minority populations. The Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in a large, diverse population of high-risk individuals and dramatically reduced rates of type 2 diabetes onset, particularly among older adults. SeniorWISE produced improvements in memory in community dwelling older persons. Transferring these exciting technologies to community settings where they can benefit older adults is a pressing public health need. Therefore, the current project seeks to transfer these two evidence-based interventions to older adults in a rural state using senior centers as the venue for dissemination and lay health educators to deliver the interventions. Senior centers are a particularly attractive context for translation of evidence-based health promotion technologies in predominantly rural states like Arkansas because they have a well-established infrastructure in communities and share a common goal of promoting healthy aging and reducing health care costs. The 3-year randomized, controlled trial will evaluate translation of the interventions by randomizing senior centers (N=16) across Arkansas to implement either (1) the DPP Lifestyle Weight Loss Program or (2) the SeniorWISE Cognitive Training Program. Older (age \\> 60) adults (N=288) nested within senior centers will receive the programs delivered in a group format by a trained lay health educator. Primary outcomes are changes in body weight and cognitive functioning at 12 months. The multi-level evaluation plan will characterize reach, effectiveness, adoption, implementation and maintenance of the interventions, with a cost effectiveness component."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for senior centers (unit of randomization):\n\n* located in the state of Arkansas\n* agree to be randomized\n* able to identify two or three volunteers or staff members willing to be trained (including IRB certification) and deliver the programs within the senior center over the course of a year\n* have adequate space for group meetings and for private data collection visits\n* agreement that it would be likely that they could identify 18 interested and eligible (obese and not cognitively impaired) senior adults willing to attend the program over the course of 12 months\n\nExclusion Criteria:\n\n* inability to identify and secure lay health educator from within their community\n* concerns of inability to recruit the requisite 18 senior adult participants who met minimal inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01377506', 'acronym': 'Coaches', 'briefTitle': 'Translation of Obesity and Cognitive Program by Lay Health Educators', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Translation of Obesity and Cognitive Research in a Rural State Via Senior Centers', 'orgStudyIdInfo': {'id': '104877'}, 'secondaryIdInfos': [{'id': 'R18DP001145', 'link': 'https://reporter.nih.gov/quickSearch/R18DP001145', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'description': 'Diabetes Prevention Program Lifestyle Balance Intervention delivered by lay health educator', 'interventionNames': ['Behavioral: lifestyle counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Training', 'description': 'Adaptation of SeniorWise Memory Training program for delivery by lay health educator, matched in duration and contact to the other study arm', 'interventionNames': ['Behavioral: Cognitive Training']}], 'interventions': [{'name': 'lifestyle counseling', 'type': 'BEHAVIORAL', 'otherNames': ['DPP Lifestyle Balance Program'], 'description': '21 session group-based behavioral weight management program delivered in senior center over 12 months by lay health educators', 'armGroupLabels': ['Lifestyle counseling']}, {'name': 'Cognitive Training', 'type': 'BEHAVIORAL', 'description': '21 session group-based cognitive training program delivered in senior center over 12 months by lay health educators', 'armGroupLabels': ['Cognitive Training']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Delia S West, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}