Chinese Diabetes Prevention Program (Chinese DPP)

NCT02277509 | Completed DMC

• 1 other identifier: 2014-3252
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (2)

• Percent Change in Weight

  12 months

• Percent Change in BMI

  12 months

Secondary Outcomes (5)

• Percent HbA1c reduction

  12 months

• Changes in Blood Pressure

  12 months

• Changes in Lipid Profile

  12 months

• Sustained changes in weight

  24 months

• Sustained changes in HbA1c

  24 months

Study Arms (2)

Chinese DPP

EXPERIMENTAL

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

Minimal Intervention Control

ACTIVE COMPARATOR

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

Interventions

Chinese DPP BEHAVIORAL

The Chinese DPP intervention will include core curriculum, stress reduction, physical activity sessions, and self-monitor diet and physical activity. .

Also known as: Culturally adapted DPP curriculum

Chinese DPP

Minimal Intervention Control BEHAVIORAL

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.

Also known as: control

Minimal Intervention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of diabetes,
• health conditions for which the lifestyle would be contra-indicated,
• inability to provide informed,
• BMI \< 23 kg/m2.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• New York Presbyterian Hospital: collaborator
• Chinese American Independent Practice Association (CAIPA): collaborator
• City University of New York: collaborator
• Pace University: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Judith Wylie-Rosett, EdD, RD

  Professor, Epidemiology & Population Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 29, 2014
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)