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Chinese Diabetes Prevention Program (Chinese DPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277509
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
New York Presbyterian Hospital
Chinese American Independent Practice Association (CAIPA)
The City University of New York (CUNY)
Pace University
Information provided by (Responsible Party):
Judith Wylie-Rosett, 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.

Condition or disease Intervention/treatment Phase
Prediabetes Behavioral: Chinese DPP Behavioral: Minimal Intervention Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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

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.
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




Primary Outcome Measures :
  1. Percent Change in Weight [ Time Frame: 12 months ]
  2. Percent Change in BMI [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Percent HbA1c reduction [ Time Frame: 12 months ]
  2. Changes in Blood Pressure [ Time Frame: 12 months ]
    Cardiovascular risk biomarkers

  3. Changes in Lipid Profile [ Time Frame: 12 months ]
    Cardiovascular risk biomarkers

  4. Sustained changes in weight [ Time Frame: 24 months ]
  5. Sustained changes in HbA1c [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
New York Presbyterian Hospital
Chinese American Independent Practice Association (CAIPA)
The City University of New York (CUNY)
Pace University
Investigators
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Principal Investigator: Judith Wylie-Rosett, EdD, RD Professor, Epidemiology & Population Health
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Responsible Party: Judith Wylie-Rosett, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02277509    
Other Study ID Numbers: 2014-3252
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases