Chinese Diabetes Prevention Program (Chinese DPP)

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Behavioral: Minimal Intervention Control; Behavioral: Chinese DPP

• Registration Number: NCT02277509
• Lead Sponsor: Albert Einstein College of Medicine

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-12
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Study Completion: 2014-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal Intervention Control	Minimal Intervention Control	The minimal control intervention will consist of providing patients with publically available materials on diabetes prevention, which are produced in Chinese.
Chinese DPP	Chinese DPP	Our Chinese DPP intervention includes: 1) skills development core adapted from the DPP core curriculum, 2) stress reduction counseling and activities, 3) physical activity sessions, 4) self-monitoring tools for diet and physical activity, 5) barriers assessment linked to tool box, and 6) post-core support intervention.

Primary Outcome Measures

Name	Time	Method
Percent Change in Weight	12 months
Percent Change in BMI	12 months

Secondary Outcome Measures

Name	Time	Method
Sustained changes in HbA1c	24 months
Changes in Blood Pressure	12 months	Cardiovascular risk biomarkers
Percent HbA1c reduction	12 months
Changes in Lipid Profile	12 months	Cardiovascular risk biomarkers
Sustained changes in weight	24 months

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States