NCT00006159

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1994

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1994

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2000

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

First QC Date

August 8, 2000

Last Update Submit

February 12, 2010

Conditions

Diabetes

Keywords

diabeteslifestyle interventionNative Americancommunity interventiondietexercise

Interventions

lifestyle (exercise, diet, and family and community support)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to complete a yearly interviewer administered questionnaire and clinical measures of height, weight, blood pressure, and fingerstick hemoglobin A1c.
  • Unable to participate in 5 lifestyle intervention meetings occurring over a one year period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico School of Medicine

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (14)

  • 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.

    BACKGROUND

  • 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)

    BACKGROUND

  • 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: 10355475BACKGROUND

  • 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: 8686981BACKGROUND

  • 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: 8422797BACKGROUND

  • 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: 2511603BACKGROUND

  • 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: 11112241BACKGROUND

  • 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: 10531855BACKGROUND

  • 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: 11140076BACKGROUND

  • 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: 10531844BACKGROUND

  • 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: 9589238BACKGROUND

  • 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: 8799636BACKGROUND

  • 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: 9048516BACKGROUND

  • 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.

    PMID: 9155311BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Interventions

ExerciseDietCommunity Support

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaCommunity ParticipationCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Janette S. Carter, MD

    University of New Mexico School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2000

First Posted

August 9, 2000

Study Start

March 1, 1994

Study Completion

January 1, 2004

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations

US(1)