Chinese Diabetes Prevention Program (Chinese DPP)
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|ClinicalTrials.gov Identifier: NCT02277509|
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes||Behavioral: Chinese DPP Behavioral: Minimal Intervention Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Chinese Diabetes Prevention Program: An Implementation and Dissemination Study|
|Actual Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Experimental: 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.
Behavioral: Chinese DPP
The Chinese DPP intervention will include core curriculum, stress reduction, physical activity sessions, and self-monitor diet and physical activity.
Other Name: Culturally adapted DPP curriculum
Active Comparator: Minimal Intervention Control
The minimal control intervention will consist of providing patients with publically available materials on diabetes prevention, which are produced in Chinese.
Behavioral: 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.
Other Name: control
- Percent Change in Weight [ Time Frame: 12 months ]
- Percent Change in BMI [ Time Frame: 12 months ]
- Percent HbA1c reduction [ Time Frame: 12 months ]
- Changes in Blood Pressure [ Time Frame: 12 months ]Cardiovascular risk biomarkers
- Changes in Lipid Profile [ Time Frame: 12 months ]Cardiovascular risk biomarkers
- Sustained changes in weight [ Time Frame: 24 months ]
- Sustained changes in HbA1c [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277509
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Judith Wylie-Rosett, EdD, RD||Professor, Epidemiology & Population Health|