Chinese Diabetes Prevention Program (Chinese DPP)

Prediabetes Clinical Trial

Official title:

Chinese Diabetes Prevention Program: An Implementation and Dissemination Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277509
• Other study ID #: 2014-3252
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2019
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prediabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (5)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Chinese American Independent Practice Association (CAIPA), New York Presbyterian Hospital, Pace University, The City University of New York (CUNY)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Weight		12 months
Primary	Percent Change in BMI		12 months
Secondary	Percent HbA1c reduction		12 months
Secondary	Changes in Blood Pressure	Cardiovascular risk biomarkers	12 months
Secondary	Changes in Lipid Profile	Cardiovascular risk biomarkers	12 months
Secondary	Sustained changes in weight		24 months
Secondary	Sustained changes in HbA1c		24 months