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Family-Centered Diabetes Project

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006159
First Posted: August 9, 2000
Last Update Posted: February 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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.

Condition Intervention
Diabetes Behavioral: lifestyle (exercise, diet, and family and community support)

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Family-Centered Diabetes Project for Pueblo Native Americans

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: March 1994
Study Completion Date: January 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006159


Locations
United States, New Mexico
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Janette S. Carter, MD University of New Mexico School of Medicine
  More Information

Additional Information:
Publications:
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.
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)

ClinicalTrials.gov Identifier: NCT00006159     History of Changes
Other Study ID Numbers: carterj (completed)
R01DK047096 ( U.S. NIH Grant/Contract )
First Submitted: August 8, 2000
First Posted: August 9, 2000
Last Update Posted: February 15, 2010
Last Verified: February 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
diabetes
lifestyle intervention
Native American
community intervention
diet
exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases