Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-28 @ 11:25 AM
Study NCT ID:
NCT01806194
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowering Rural African American Women and Communities to Improve Diabetes Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-19', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '6 months', 'description': 'Blood pressure'}, {'measure': 'Blood Pressure', 'timeFrame': '12 Months', 'description': 'Blood pressure'}], 'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c', 'timeFrame': '6 months', 'description': 'Glycosylated hemoglobin'}, {'measure': 'Change in Hemoglobin A1c', 'timeFrame': '12 Months', 'description': 'Glycosylated hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': '6 Months', 'description': 'Body weight'}, {'measure': 'Change in Weight', 'timeFrame': '12 Months', 'description': 'Body Weight'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23792133', 'type': 'BACKGROUND', 'citation': 'Cummings DM, Lutes LD, Littlewood K, Dinatale E, Hambidge B, Schulman K. EMPOWER: a randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: design, rationale, and baseline characteristics. Contemp Clin Trials. 2013 Sep;36(1):147-53. doi: 10.1016/j.cct.2013.06.006. Epub 2013 Jun 19.'}, {'pmid': '24904183', 'type': 'BACKGROUND', 'citation': 'Cummings DM, Lutes L, Littlewood K, DiNatale E, Hambidge B, Schulman K, Morisky DE. Regimen-Related Distress, Medication Adherence, and Glycemic Control in Rural African American Women With Type 2 Diabetes Mellitus. Ann Pharmacother. 2014 Aug;48(8):970-977. doi: 10.1177/1060028014536532. Epub 2014 Jun 5.'}, {'pmid': '28660719', 'type': 'DERIVED', 'citation': 'Lutes LD, Cummings DM, Littlewood K, Dinatale E, Hambidge B. A Community Health Worker-Delivered Intervention in African American Women with Type 2 Diabetes: A 12-Month Randomized Trial. Obesity (Silver Spring). 2017 Aug;25(8):1329-1335. doi: 10.1002/oby.21883. Epub 2017 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach.', 'detailedDescription': 'East Carolina University, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural African American women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. The focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. The intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. The study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. We hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American female,\n* age 19 - 75yr.,\n* with Type 2 diabetes mellitus and\n* living in or near Bertie, Edgecombe, and Pitt counties in eastern NC\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01806194', 'acronym': 'EMPOWER', 'briefTitle': 'Empowering Rural African American Women and Communities to Improve Diabetes Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Empowering Rural African American Women and Communities to Improve Diabetes Outcomes', 'orgStudyIdInfo': {'id': '212196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Educational control arm', 'description': 'Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers', 'interventionNames': ['Behavioral: Educational Control Arm']}, {'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'description': 'Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers.', 'interventionNames': ['Behavioral: Lifestyle Counseling']}], 'interventions': [{'name': 'Lifestyle Counseling', 'type': 'BEHAVIORAL', 'description': 'Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers', 'armGroupLabels': ['Lifestyle counseling']}, {'name': 'Educational Control Arm', 'type': 'BEHAVIORAL', 'description': '16 mailings of diabetes educational materials but no regular contact with community health workers', 'armGroupLabels': ['Educational control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Doyle M. Cummings, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}, {'name': 'Lesley Lutes, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Family Medicine', 'investigatorFullName': 'Doyle M. Cummings', 'investigatorAffiliation': 'East Carolina University'}}}}