Clinical trial NCT02277509: Chinese Diabetes Prevention Program (Chinese DPP)
Official title: Chinese Diabetes Prevention Program: An Implementation and Dissemination Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
name: Chinese American Independent Practice Association (CAIPA)
name: City University of New York
name: Pace University
First posted: 2014-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Percent Change in Weight
timeFrame: 12 months
measure: Percent Change in BMI
timeFrame: 12 months
Secondary outcomes:
measure: Percent HbA1c reduction
timeFrame: 12 months
measure: Changes in Blood Pressure
timeFrame: 12 months
measure: Changes in Lipid Profile
timeFrame: 12 months
measure: Sustained changes in weight
timeFrame: 24 months
measure: Sustained changes in HbA1c
timeFrame: 24 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Professor, Epidemiology & Population Health
name: Judith Wylie-Rosett, EdD, RD
role: PRINCIPAL_INVESTIGATOR
References: