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Chinese Diabetes Prevention Program (Chinese DPP)

Chinese Diabetes Prevention Program: An Implementation and Dissemination Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02277509
Enrollment
60
Registered
2014-10-29
Start date
2012-04-30
Completion date
2014-12-31
Last updated
2019-02-06

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

Conditions

Prediabetes

Brief summary

This study is being conducted in two phases. The first phase was a pilot implementation of the study protocol, which provided preliminary data from seeking funding for a larger scale trial. The study focused on testing the effects of a Diabetes Prevention Program (DPP) that has been adapted culturally and linguistically to address diabetes prevention among Chinese immigrants. Study implementation involves a variety capacity building community partnership initiatives. Partnering organizations within New York City (NYC) have included the Chinese Community Partnership for Health (CCPH) of New York Presbyterian Hospital of Lower Manhattan Hospital, the Chinese American Independent Practice Association (CAIPA), the Diabetes Research and Training Center of Albert Einstein College of Medicine (Einstein), and the City University of New York (CUNY) School of Public Health. More recently, our collaboration has expanded the potential for wider dissemination in collaboration with the Pace University Confucius Center of the Confucius Institute. By supporting Chinese language and cultural programs, the Confucius Institute facilitates communication with the 2 billion native Chinese speakers as migration and trade increase interactions globally.

Detailed description

The pilot testing (Einstein Institutional Review Board Protocol #2010-491) demonstrated the acceptability and feasibility of implementing the culturally and linguistically Chinese DPP lifestyle protocol. The pilot study found that the intervention resulted in a significant weight loss and trends for glycemic (HbA1c) improvement among Chinese immigrants with prediabetes. The planned R01 funded study will address larger scale implementation to inform wider spread dissemination within the United States and globally. Our specific aims are to: Aim 1. Evaluate the clinical effectiveness of the implementation model in a cluster randomized trial. Primary endpoints will include changes in weight and glycemia (HbA1c ) one year after randomization. Secondary endpoint will include cardiovascular risk markers, lifestyle (dietary intake and physical activity) and self-reported quality of life. Aim 2. Evaluate the study generalizability using the RE-AIM (reach, efficacy/effectiveness, adoption, implementation and maintenance) framework. The specific evaluation questions include: Reach: How many of the eligible patients enrolled? How representative are the study participants of the underlying population? Efficacy/Effectiveness: How did the intervention affect participants' outcome measures? Adoption: How acceptable were the intervention components to the participants? Implementation: How many of the intervention components were provided as planned? Maintenance: How much of the 1-year intervention effects are sustainable at 2-year follow-up? What mechanisms are available for sustaining the intervention? Aim 3. Evaluate the cost-effectiveness of the implementation model with respects to weight and glycemic (HbA1c) change. Aim 4. Disseminate lessons learned and effective program components to expand access to effective programs within the United States via the registry developed by the Centers for Disease Control of DPP intervention sites and to explore global dissemination issues via our partnership with Confucius Institute.

Interventions

BEHAVIORALChinese DPP

The Chinese DPP intervention will include core curriculum, stress reduction, physical activity sessions, and self-monitor diet and physical activity. .

BEHAVIORALMinimal Intervention Control

Patients will receive printed diabetes prevention materials in Chinese. Materials will be from primary from the National Diabetes Education Program and from the New York City Department off Health and Mental Hygiene. Patients will receive an educational packet at randomization and quarterly thereafter.

Sponsors

New York Presbyterian Hospital
CollaboratorOTHER
Chinese American Independent Practice Association (CAIPA)
CollaboratorOTHER
City University of New York
CollaboratorOTHER
Pace University
CollaboratorOTHER
Albert Einstein College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* prediabetes (A1c -5.5-6.4%), * BMI ≥ 23 kg/m2, * ability to read and understand Chinese, * enrollment in CAIPA network, * ability and willingness to provide informed consent.

Exclusion criteria

* Diagnosis of diabetes, * health conditions for which the lifestyle would be contra-indicated, * inability to provide informed, * BMI \< 23 kg/m2.

Design outcomes

Primary

MeasureTime frame
Percent Change in Weight12 months
Percent Change in BMI12 months

Secondary

MeasureTime frameDescription
Changes in Lipid Profile12 monthsCardiovascular risk biomarkers
Percent HbA1c reduction12 months
Sustained changes in HbA1c24 months
Sustained changes in weight24 months
Changes in Blood Pressure12 monthsCardiovascular risk biomarkers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026