PrediabetesNCT02277509
Chinese Diabetes Prevention Program (Chinese DPP)
A study testing Chinese DPP in people with Prediabetes, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Chinese DPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of diabetes,
- health conditions for which the lifestyle would be contra-indicated,
- inability to provide informed,
- BMI < 23 kg/m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Chinese Diabetes Prevention Program: An Implementation and Dissemination Study
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.
Read the 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.
- Conditions
- Prediabetes
- Being tested
- Chinese DPP, Minimal Intervention Control
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese DPPBehavioural
Also called Culturally adapted DPP curriculum
The Chinese DPP intervention will include core curriculum, stress reduction, physical activity sessions, and self-monitor diet and physical activity.
.
Minimal Intervention ControlBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Minimal Intervention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Weight
Measured: 12 months
Percent Change in BMI
Measured: 12 months
Secondary outcomes (5)
Percent HbA1c reduction
Measured: 12 months
Changes in Blood Pressure
Cardiovascular risk biomarkers
Measured: 12 months
Changes in Lipid Profile
Cardiovascular risk biomarkers
Measured: 12 months
Sustained changes in weight
Measured: 24 months
Sustained changes in HbA1c
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital, Chinese American Independent Practice Association (CAIPA), City University of New York, Pace University
- Responsible party
- Principal investigator, Judith Wylie-Rosett, Albert Einstein College of Medicine
- Investigators
- Judith Wylie-Rosett, EdD, RD, Principal investigator, Professor, Epidemiology & Population Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277509
- Sponsor's protocol ID
- 2014-3252
- Status last verified
- Feb 2019
- First submitted
- 15 Oct 2014
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Diabetes Prevention Program: An Implementation and Dissemination Study
- ClinicalTrials.gov ID
- NCT02277509
- Acronym / sponsor ID
- 2014-3252
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital, Chinese American Independent Practice Association (CAIPA), City University of New York, Pace University
- Study start
- Apr 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese DPP | Experimental | Behavioral: Chinese DPPOur 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. |
| Minimal Intervention Control | Active comparator | Behavioral: Minimal Intervention ControlThe minimal control intervention will consist of providing patients with publically available materials on diabetes prevention, which are produced in Chinese. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Diagnosis of diabetes,
- health conditions for which the lifestyle would be contra-indicated,
- inability to provide informed,
- BMI < 23 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese DPPAlso: Culturally adapted DPP curriculumThe Chinese DPP intervention will include core curriculum, stress reduction, physical activity sessions, and self-monitor diet and physical activity. . | Behavioural | Chinese DPP |
| Minimal Intervention ControlAlso: controlPatients 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. | Behavioural | Minimal Intervention Control |
Primary outcome
Percent Change in Weight
Time frame: 12 months
Percent Change in BMI
Time frame: 12 months
5 secondary outcomes
Percent HbA1c reduction
Time frame: 12 months
Changes in Blood Pressure
Time frame: 12 months
Changes in Lipid Profile
Time frame: 12 months
Sustained changes in weight
Time frame: 24 months
Sustained changes in HbA1c
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Wylie-Rosett, EdD, RD principal investigator
Professor, Epidemiology & Population Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese DPP in people with Prediabetes, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Weight (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.