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NCT04835636 Clinical Trial

Modified Diabetes Prevention Program in Ecuador

PreDiabetes Clinical Trial

Official title:
A Pilot of a Modified Diabetes Prevention Program in Quito, Ecuador

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04835636
Other study ID # OHTU2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date September 1, 2016

Study information
Verified date April 2022
Source Ohio University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date September 1, 2016
Est. primary completion date September 1, 2016
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Diabetes Prevention Program
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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ohio University Touro University, California

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c measure of glucose over 90-120 days 90-120 days
Secondary Weight change change in weight over the 6 month program 6 months
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