- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277509
Chinese Diabetes Prevention Program (Chinese DPP)
Chinese Diabetes Prevention Program: An Implementation and Dissemination Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10461
- Albert Einstein College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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The Chinese DPP intervention will include core curriculum, stress reduction, physical activity sessions, and self-monitor diet and physical activity. .
Other Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Change in Weight
Time Frame: 12 months
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12 months
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Percent Change in BMI
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent HbA1c reduction
Time Frame: 12 months
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12 months
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Changes in Blood Pressure
Time Frame: 12 months
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Cardiovascular risk biomarkers
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12 months
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Changes in Lipid Profile
Time Frame: 12 months
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Cardiovascular risk biomarkers
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12 months
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Sustained changes in weight
Time Frame: 24 months
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24 months
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Sustained changes in HbA1c
Time Frame: 24 months
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24 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Judith Wylie-Rosett, EdD, RD, Professor, Epidemiology & Population Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-3252
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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