Type 2 DiabetesNCT01238289
Randomized Trial of Peer Led Education-Project Dulce
A study testing Peer Education in people with Type 2 Diabetes, run by Scripps Whittier Diabetes Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Peer Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2010
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mexican American, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in San Diego County with type 2 diabetes and HbA1c > or = 8%.
Who cannot join
- Individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, HbA1c < 8,pregnant with gestational diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
About this study
Official title: Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial
The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format.
Read the detailed description
To recruit 207 Mexican-Americans patients from federally-funded community health centers in San Diego County with Hemoglobin A1c (HbA1c) > 8% and randomize to Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome will be the percent change in HbA1c levels at 10 months following randomization.
- Conditions
- Type 2 Diabetes
- Being tested
- Peer Education, Control
- Keywords
- peer education, diabetes, randomized, trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer EducationBehavioural
Also called Project Dulce
Conduct peer education classes for 8 weeks and support groups monthly for a total of 10 months and evaluate effects on metabolic and behavior outcomes
ControlBehavioural
This group continues with standard care at the community health center
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | This arm continues with standard care at community clinic Receives: Behavioral: Control |
| Peer Education | Experimental | This group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months Receives: Behavioral: Peer Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean percent change Hemoglobin A1c (HbA1c)
Evaluate change in HbA1c over a 10 month time period from baseline.
Measured: Baseline, 4 months and 10 months
Secondary outcomes (1)
Body mass index, blood pressure and lipid changes
Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline
Measured: Baseline, 4 months and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startSep 2006
- Primary completionMar 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR), San Diego State University
- Responsible party
- Principal investigator, Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Whittier Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238289
- Sponsor's protocol ID
- R18DK070666-01A1
- Other IDs
- R18DK070666-01A1
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2010
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial
- ClinicalTrials.gov ID
- NCT01238289
- Acronym / sponsor ID
- R18DK070666-01A1
- Conditions
- Type 2 Diabetes
- Keywords
- peer education, diabetes, randomized, trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR), San Diego State University
- Study start
- Sep 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Nov 2010 (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.
The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format.
Detailed description
To recruit 207 Mexican-Americans patients from federally-funded community health centers in San Diego County with Hemoglobin A1c (HbA1c) > 8% and randomize to Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome will be the percent change in HbA1c levels at 10 months following randomization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: ControlThis arm continues with standard care at community clinic |
| Peer Education | Experimental | Behavioral: Peer EducationThis group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mexican American, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in San Diego County with type 2 diabetes and HbA1c > or = 8%.
Key exclusion criteria (1 listed)
- Individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, HbA1c < 8,pregnant with gestational diabetes
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 |
|---|---|---|
| Peer EducationAlso: Project DulceConduct peer education classes for 8 weeks and support groups monthly for a total of 10 months and evaluate effects on metabolic and behavior outcomes | Behavioural | Peer Education |
| ControlThis group continues with standard care at the community health center | Behavioural | Control group |
Primary outcome
mean percent change Hemoglobin A1c (HbA1c)
Time frame: Baseline, 4 months and 10 months
Evaluate change in HbA1c over a 10 month time period from baseline.
1 secondary outcome
Body mass index, blood pressure and lipid changes
Time frame: Baseline, 4 months and 10 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 9 Dec 2022.
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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.
Athena Philis-Tsimikas, MD principal investigator
Scripps Whittier Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Education in people with Type 2 Diabetes, run by Scripps Whittier Diabetes Institute 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 1 inclusion and 1 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 9 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
mean percent change Hemoglobin A1c (HbA1c) (time frame: Baseline, 4 months and 10 months). 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 9 Dec 2022.