Diabetes Mellitus, Type 2NCT00006165
Native Hawaiian Diabetes Intervention Program
A study testing 'Ohana (Family) Support Lifestyle Intervention in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 'Ohana (Family) Support Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii, John A. Burns School of Medicine
Honolulu, Hawaii, 96813
About this study
Official title: Cultural-based Diabetes Program for Native Hawaiians
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 'Ohana (Family) Support Lifestyle Intervention
- Keywords
- Native Hawaiian, Diabetes Mellitus, Lifestyle Intervention, Family Support, Diabetes Mellitus, at-risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Ohana (Family) Support Lifestyle InterventionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Marjorie K. Mau, M. D., Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006165
- Sponsor's protocol ID
- maum (completed)
- Other IDs
- DK 48136
- Status last verified
- Mar 2010
- First submitted
- 8 Aug 2000
- Last updated
- 2 Mar 2010
- Results posted
- No
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. doi: 10.2337/diacare.20.9.1376.
PubMed 9283783Diabetes 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.
PubMed 7860292Grandinetti 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. doi: 10.2337/diacare.21.4.549.
PubMed 9571341
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural-based Diabetes Program for Native Hawaiians
- ClinicalTrials.gov ID
- NCT00006165
- Acronym / sponsor ID
- maum (completed)
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Native Hawaiian, Diabetes Mellitus, Lifestyle Intervention, Family Support, Diabetes Mellitus, at-risk
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- First posted
- 9 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Ohana (Family) Support Lifestyle Intervention | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- BackgroundGilliland 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.
- BackgroundMau 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
- Background: PubMed 9283783Mau 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. doi: 10.2337/diacare.20.9.1376.
- Background: PubMed 7860292Diabetes 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.
- Background: PubMed 9571341Grandinetti 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. doi: 10.2337/diacare.21.4.549.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie K. Mau, M. D. principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Ohana (Family) Support Lifestyle Intervention in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006165, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.