Chinese Diabetes Prevention Program (Chinese DPP)

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.
Brief Title
Chinese Diabetes Prevention Program (Chinese DPP)
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.
Completion Date
Completion Date Type
Actual
Conditions
Prediabetes
Eligibility Criteria
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.
Inclusion Criteria
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.

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02277509
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2014-3252
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Chinese Diabetes Prevention Program: An Implementation and Dissemination Study
Primary Outcomes
Outcome Measure
Percent Change in Weight
Outcome Time Frame
12 months
Outcome Measure
Percent Change in BMI
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Time Frame
12 months
Outcome Measure
Percent HbA1c reduction
Outcome Description
Cardiovascular risk biomarkers
Outcome Time Frame
12 months
Outcome Measure
Changes in Blood Pressure
Outcome Description
Cardiovascular risk biomarkers
Outcome Time Frame
12 months
Outcome Measure
Changes in Lipid Profile
Outcome Time Frame
24 months
Outcome Measure
Sustained changes in weight
Outcome Time Frame
24 months
Outcome Measure
Sustained changes in HbA1c
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Judith Wylie-Rosett
Investigator Email
judith.wylie-rosett@einsteinmed.org
Investigator Phone