Modified Diabetes Prevention Program in Ecuador

April 21, 2022 updated by: Ohio University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

33

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The faculty and staff at PUCE University in Quito Ecuador were invited to participate in the study.

Description

Inclusion Criteria: Adults who worked at the university and had biochemical prediabetes.

-

Exclusion Criteria: Those with known diabetes, those unwilling to complete a 6 month intervention.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 90-120 days
measure of glucose over 90-120 days
90-120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: 6 months
change in weight over the 6 month program
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio University

Collaborators

Touro University, California

Investigators

  • Study Director: Jay H Shubrook, DO, Ohio University/Touro University California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHTU2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share any patient identifier information with anyone outside the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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