Modified Diabetes Prevention Program in Ecuador | NCT04835636

Studies
Modified Diabetes Prevention Program in Ecuador

NCT04835636

Sponsor

Ohio University

Status

Completed

Last Update Posted

Apr 29, 2022Actual

Enrollment

33Actual

Phase

Not provided

Conditions

PreDiabetes

Interventions

Diabetes Prevention Program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Sep 1, 2016Actual

Completion Date

Sep 1, 2016Actual

First Submitted Date

Apr 4, 2021

First Submission Date that Met QC Criteria

Apr 6, 2021

First Posted Date

Apr 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 29, 2022Actual

Name	Class
Touro University, California	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diabetes Prevention Program	Behavioral	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jay H Shubrook, DO	Ohio University/Touro University California	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011236	Prediabetic State

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided