Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 10:12 PM
Study NCT ID:
NCT00006159
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2000-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-Centered Diabetes Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D000091443', 'term': 'Community Support'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003256', 'term': 'Community Participation'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-12', 'studyFirstSubmitDate': '2000-08-08', 'studyFirstSubmitQcDate': '2000-08-08', 'lastUpdatePostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-08-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['diabetes', 'lifestyle intervention', 'Native American', 'community intervention', 'diet', 'exercise'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Gilliland SS, Carter JS, Perez GE, Two Feathers J, Kenui CK, Mau MK. Recommendations for development and adaptation of culturally competent community health interventions in minority populations with Type 2 diabetes mellitus. Diabetes Spectrum 11:166-174, 1998.'}, {'type': 'BACKGROUND', 'citation': "McFee T, Cunningham-Sabo LD, Perez GE, Gilliland SS, Carter JS. A feast day poster: Healthful and successful modification of holiday foods. J Nutr Educ 29:356B, 1997. (two page ''GEM'' article)"}, {'pmid': '10355475', 'type': 'BACKGROUND', 'citation': 'Stolarczyk LM, Gilliland SS, Lium DJ, Owen CL, Perez GE, Kriska AM, Ainsworth BE, Carter JS. Knowledge, attitudes and behaviors related to physical activity among Native Americans with diabetes. Ethn Dis. 1999 Winter;9(1):59-69.'}, {'pmid': '8686981', 'type': 'BACKGROUND', 'citation': 'Carter JS, Pugh JA, Monterrosa A. Non-insulin-dependent diabetes mellitus in minorities in the United States. Ann Intern Med. 1996 Aug 1;125(3):221-32. doi: 10.7326/0003-4819-125-3-199608010-00011.'}, {'pmid': '8422797', 'type': 'BACKGROUND', 'citation': "Carter JS, Wiggins CL, Becker TM, Key CR, Samet JM. Diabetes mortality among New Mexico's American Indian, Hispanic, and non-Hispanic white populations, 1958-1987. Diabetes Care. 1993 Jan;16(1):306-9. doi: 10.2337/diacare.16.1.306."}, {'pmid': '2511603', 'type': 'BACKGROUND', 'citation': 'Carter J, Horowitz R, Wilson R, Sava S, Sinnock P, Gohdes D. Tribal differences in diabetes: prevalence among American Indians in New Mexico. Public Health Rep. 1989 Nov-Dec;104(6):665-9.'}, {'pmid': '11112241', 'type': 'BACKGROUND', 'citation': 'Carter JS, Gilliland SS, Perez GE, Skipper B, Gilliland FD. Public health and clinical implications of high hemoglobin A1c levels and weight in younger adult Native American people with diabetes. Arch Intern Med. 2000 Dec 11-25;160(22):3471-6. doi: 10.1001/archinte.160.22.3471.'}, {'pmid': '10531855', 'type': 'BACKGROUND', 'citation': 'Griffin JA, Gilliland SS, Perez G, Helitzer D, Carter JS. Participant satisfaction with a culturally appropriate diabetes education program: the Native American Diabetes Project. Diabetes Educ. 1999 May-Jun;25(3):351-63. doi: 10.1177/014572179902500306.'}, {'pmid': '11140076', 'type': 'BACKGROUND', 'citation': 'Griffin JA, Gilliland SS, Perez G, Upson D, Carter JS. Challenges to participating in a lifestyle intervention program: the Native American Diabetes Project. Diabetes Educ. 2000 Jul-Aug;26(4):681-9. doi: 10.1177/014572170002600416.'}, {'pmid': '10531844', 'type': 'BACKGROUND', 'citation': 'Carter JS, Perez GE, Gilliland SS. Communicating through stories: experience of the Native American Diabetes Project. Diabetes Educ. 1999 Mar-Apr;25(2):179-88. doi: 10.1177/014572179902500204.'}, {'pmid': '9589238', 'type': 'BACKGROUND', 'citation': 'Gilliland SS, Willmer AJ, McCalman R, Davis SM, Hickey ME, Perez GE, Owen CL, Carter JS. Adaptation of the Dartmouth COOP Charts for use among American Indian people with diabetes. Diabetes Care. 1998 May;21(5):770-6. doi: 10.2337/diacare.21.5.770.'}, {'pmid': '8799636', 'type': 'BACKGROUND', 'citation': 'Carter JS, Houston CA, Gilliland SS, Perez GE, Owen CL, Pathak DR, Little RR. Rapid HbA1c testing in a community setting. Diabetes Care. 1996 Jul;19(7):764-7. doi: 10.2337/diacare.19.7.764.'}, {'pmid': '9048516', 'type': 'BACKGROUND', 'citation': 'Gilliland FD, Owen C, Gilliland SS, Carter JS. Temporal trends in diabetes mortality among American Indians and Hispanics in New Mexico: birth cohort and period effects. Am J Epidemiol. 1997 Mar 1;145(5):422-31. doi: 10.1093/oxfordjournals.aje.a009124.'}, {'pmid': '9155311', 'type': 'BACKGROUND', 'citation': 'Carter JS, Gilliland SS, Perez GE, Levin S, Broussard BA, Valdez L, Cunningham-Sabo LD, Davis SM. Native American Diabetes Project: designing culturally relevant education materials. Diabetes Educ. 1997 Mar-Apr;23(2):133-4, 139. doi: 10.1177/014572179702300203. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.laplaza.org/health/dwc/prof/nadp/', 'label': 'The intervention curricula, Strong in Body and Spirit! (participant version) is located at this web site and may be downloaded.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to determine whether a diabetes lifestyle program will improve the lives of Native American people living with diabetes. We recruited Native American people living in 8 Pueblo communities served by 3 Indian Health Service clinics. Forty percent of people living with diabetes in those communities participated in an interview and had height, weight, blood pressure and hemoglobin A1c measured at the beginning. Then they received a lifestyle program in either groups or one-on-one, or another group which got the intervention after one year (comparison group). The program was developed using input from community members, tribal leaders, and clinic staff, and was taught by community members in or near the participating communities. After each session, participants were asked for feedback about the curriculum. After the program ended, the interview and clinical measures were repeated. Feedback to tribal leaders and clinical staff is ongoing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 years or older with diabetes living in a participating Native American community served by one of three participating Indian Health Service clinics.\n\nExclusion Criteria:\n\n* Unable to complete a yearly interviewer administered questionnaire and clinical measures of height, weight, blood pressure, and fingerstick hemoglobin A1c.\n* Unable to participate in 5 lifestyle intervention meetings occurring over a one year period.'}, 'identificationModule': {'nctId': 'NCT00006159', 'briefTitle': 'Family-Centered Diabetes Project', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Family-Centered Diabetes Project for Pueblo Native Americans', 'orgStudyIdInfo': {'id': 'carterj (completed)'}, 'secondaryIdInfos': [{'id': 'R01DK047096', 'link': 'https://reporter.nih.gov/quickSearch/R01DK047096', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'lifestyle (exercise, diet, and family and community support)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico School of Medicine', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Janette S. Carter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}}}}