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Community-Based Diabetes Care for Korean American Immigrants

Community-Based Diabetes Care for Korean American Immigrants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01264796
Enrollment
250
Registered
2010-12-22
Start date
2009-11-30
Completion date
2015-08-31
Last updated
2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Korean American, type 2 diabetes, culturally tailored

Brief summary

The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a comprehensive, culturally tailored DM management intervention, in improving glucose outcomes; To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care skills and psycho-behavioral outcomes related to DM control, to develop tangible infrastructures for the dissemination of valid and effective education materials to a wider population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based intervention materials, mobile telephone-based intervention materials) and to explore the feasibility and acceptability of each dissemination module, utilizing the delayed intervention group participants. The secondary aims are to obtain preliminary cost-effectiveness data related to the proposed intervention, including cost estimates for this type of DM intervention, and to establish a systematic, long-term dissemination plan, including documenting effective methodologies, to facilitate faster translation of research findings and products to direct consumers in non-research settings.

Detailed description

Inclusion Criteria 1. Self-identified as a first generation Korean American 2. Type 2 diabetes 3. Age 30-75 years 4. Resides in Washington-Baltimore area 5. Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening 6. Expresses willingness to participate in all aspects of the study over its full course Exclusion criteria 1. Unable to give informed consent 2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases) 3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia 4. Past experience in diabetes group education

Interventions

BEHAVIORALculturally tailored diabetes education

lifestyle modification group education

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Self-identified as a first generation Korean American 2. Type 2 diabetes 3. Age 30-75 years 4. Resides in Washington-Baltimore area 5. Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening 6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion criteria

1. Unable to give informed consent 2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases) 3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia 4. Past experience in diabetes group education

Design outcomes

Primary

MeasureTime frameDescription
HbA1c12monthHbA1c level change from baseline comparing with control group
Blood pressure12 monthBP change from baseline comparing with control group
Lipid profile12 monthsLDL level change from baseline comparing with control group
quality of life12monthquality of life score change from baseline comparing with control group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026