PreDiabetesNCT04835636
Modified Diabetes Prevention Program in Ecuador
An observational study of PreDiabetes, run by Ohio University.
Trial summary
This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Diabetes Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Sep 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The faculty and staff at PUCE University in Quito Ecuador were invited to participate in the study.
Inclusion Criteria: Adults who worked at the university and had biochemical prediabetes.
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Exclusion Criteria: Those with known diabetes, those unwilling to complete a 6 month intervention.
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About this study
Official title: A Pilot of a Modified Diabetes Prevention Program in Quito, Ecuador
This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador.
Read the detailed description
This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador. People who took the program had the option to participate in the research component. All participants selected the research component.
Adaptations- the coaches will be physicians from PUCE and they will administer this program for eligible employees who have biochemical prediabetes.
The program will be modified to be able to fit within the school curriculum. The diabetes prevention program will be offered in Spanish and the content modified to better fit the cultural norms for the Quito Ecuador population.
Participants will be adults with prediabetes as screened by the CDC Diabetes Risk Test and confirmed by HbA1c.
Outcome measures will include change in mean HbA1c, change in weight, physical activity, and attendance to the program.
- Conditions
- PreDiabetes
- Being tested
- Diabetes Prevention Program
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention ProgramBehavioural
This program is a 1 year lifestyle modification program focused on reducing calories and fat calories and increasing physical activity to achieve a 7% weight loss. This study utilized the first 16 sessions (6 months) of the program
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
measure of glucose over 90-120 days
Measured: 90-120 days
Secondary outcomes (1)
Weight change
change in weight over the 6 month program
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jan 2016
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Touro University, California
- Responsible party
- Sponsor
- Investigators
- Jay H Shubrook, DO, Study director, Ohio University/Touro University California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835636
- Sponsor's protocol ID
- OHTU2021
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share any patient identifier information with anyone outside the study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot of a Modified Diabetes Prevention Program in Quito, Ecuador
- ClinicalTrials.gov ID
- NCT04835636
- Acronym / sponsor ID
- OHTU2021
- Conditions
- PreDiabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Touro University, California
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 8 Apr 2021 (actual)
- 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 pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador.
Detailed description
This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador. People who took the program had the option to participate in the research component. All participants selected the research component.
Adaptations- the coaches will be physicians from PUCE and they will administer this program for eligible employees who have biochemical prediabetes.
The program will be modified to be able to fit within the school curriculum. The diabetes prevention program will be offered in Spanish and the content modified to better fit the cultural norms for the Quito Ecuador population.
Participants will be adults with prediabetes as screened by the CDC Diabetes Risk Test and confirmed by HbA1c.
Outcome measures will include change in mean HbA1c, change in weight, physical activity, and attendance to the program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The faculty and staff at PUCE University in Quito Ecuador were invited to participate in the study.
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 |
|---|---|---|
| Diabetes Prevention ProgramThis program is a 1 year lifestyle modification program focused on reducing calories and fat calories and increasing physical activity to achieve a 7% weight loss. This study utilized the first 16 sessions (6 months) of the program | Behavioural | – |
Primary outcome
HbA1c
Time frame: 90-120 days
measure of glucose over 90-120 days
1 secondary outcome
Weight change
Time frame: 6 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 29 Apr 2022.
- Individual participant dataSharing planned: No. We will not share any patient identifier information with anyone outside the study.
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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.
Jay H Shubrook, DO study director
Ohio University/Touro University California
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, run by Ohio University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
HbA1c (time frame: 90-120 days). 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 29 Apr 2022.