Native Hawaiian Diabetes Intervention Program

This study has been completed.

Sponsor:

Information provided by:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier:

NCT00006165

First received: August 8, 2000

Last updated: March 1, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 8, 2000

Last Updated Date

March 1, 2010

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00006165 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Native Hawaiian Diabetes Intervention Program

Official Title ^ICMJE

Cultural-based Diabetes Program for Native Hawaiians

Brief Summary

The Native Hawaiian Diabetes Intervention Program is a project focused on determining whether a cultural-based, healthy lifestyles program with family support will have a positive effect on lifestyle behaviors and psychosocial and clinical outcomes. A culturally sensitive, lifestyle intervention program was administered via community peer educators to a population of Native Hawaiians with or at risk for diabetes. The effect of this intervention program on selected outcomes is being compared to a ''standard'' program given to a similar population in a second Native Hawaiian community.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Primary Purpose: Prevention

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Behavioral: 'Ohana (Family) Support Lifestyle Intervention

Study Arm (s)

Not Provided

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(3):166-174, 1998.
Mau MK, Glanz K Chen R, Crabbe K, Severino R, Grove J, Curb JD, Arakaki RF. Lifestyle Behaviors and Mediating Factors for Behavior Change in Response to a Culturally-Responsive Intervention for Native Hawaiians. Diabetes, 1391A, 1999
Mau MK, Grandinetti A, Arakaki RF, Chang HK, Kinney EK, Curb JD. The insulin resistance syndrome in native Hawaiians. Native Hawaiian Health Research (NHHR) Project. Diabetes Care. 1997 Sep;20(9):1376-80.
[No authors listed] Diabetes mellitus and heart disease risk factors in Hawaiians. The Native Hawaiian Health Research Project, RCMI Program. Hawaii Med J. 1994 Dec;53(12):340-3, 364. No abstract available.
Grandinetti A, Chang HK, Mau MK, Curb JD, Kinney EK, Sagum R, Arakaki RF. Prevalence of glucose intolerance among Native Hawaiians in two rural communities. Native Hawaiian Health Research (NHHR) Project. Diabetes Care. 1998 Apr;21(4):549-54.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participant must be a Native Hawaiian adult 30 years of age or older residing in the research community and have diabetes or at-risk for diabetes.
Family support member must be 18 years or older and live in the study community and be willing to go through the entire program with the participant as their support person.
Physician clearance to participate in the program.

Exclusion Criteria:

Pregnancy

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00006165

Other Study ID Numbers ^ICMJE

maum (completed), DK 48136

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marjorie K. Mau, M. D.

University of Hawaii

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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