NCT04835636

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 4, 2021

Last Update Submit

April 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    measure of glucose over 90-120 days

    90-120 days

Secondary Outcomes (1)

  • Weight change

    6 months

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jay H Shubrook, DO

    Ohio University/Touro University California

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 8, 2021

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

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