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NCT03159299 · ClinicalTrials.gov registry record · NA

Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City

A NA study of Type 2 Diabetes Mellitus, sponsored by Yale University.

Completed
Registry status
NA
Development phase
47
Enrollment target
1
Study location

NCT03159299 is a NA study of Type 2 Diabetes Mellitus that has completed, run by Yale University. The registered enrollment target is 47 participants, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03159299, a NA study of Type 2 Diabetes Mellitus, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
47 participants
Enrollment target
1
Study location

Study Summary

The aims of this study are: 1. To translate an evidence-based diabetes self-management education (DSME) program, Yo Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro Popular clinics in Mexico. The program will be adapted through a collaborative team of diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians, nurses and adults with type 2 diabetes (T2D) in Mexico City, Mexico. This will include development and testing of a theory-based mHealth (pictorial text-messaging) component. 2. To evaluate the feasibility (process of implementation, fidelity of sessions, attendance, attrition), acceptability (interviews with nurse, CHW, participants) and preliminary efficacy of Yo Puedo!+mHealth in adults with T2D in Mexico City. A randomized, controlled pilot study design will be used in which 40 adults with T2D are randomized to the Yo Puedo! + mHealth or a wait-list control condition with the hypothesis that clinical \[A1C, body mass index (BMI), blood pressure (BP)\], T2D self-management, and self-efficacy outcomes will be greater in You Puedo!+mHealth participants compared to the wait-list control condition at 3 and 6 month follow-up. A secondary hypothesis that the Yo Puedo! + mHealth program is feasible and acceptable to adults with T2D and providers and that fidelity of the program will be maintained.

Conditions Studied

Type 2 Diabetes Mellitus

Interventions

  • BEHAVIORAL Yo Puedo + mHealth

Study Locations (1)

Connecticut

  • Yale School of Nursing - Orange

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2017-05-08
Est. Completion 2019-06-30
Phase NA

Sponsor

Yale University

1,492 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03159299

The ClinicalTrials.gov registry entry for NCT03159299 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Yo Puedo + mHealth is the first listed.

NCT03159299 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT03159299 about?

NCT03159299 is a clinical study titled "Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City". The aims of this study are: 1. To translate an evidence-based diabetes self-management education (DSME) program, Yo Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro Popular clinics in Mexico. The program will be adapted through a collaborative team of diabetes ex...

What is the current status of trial NCT03159299?

This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2017-05-08. Estimated completion is 2019-06-30.

What conditions does trial NCT03159299 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT03159299?

The interventions under investigation include: Yo Puedo + mHealth (BEHAVIORAL).

Who is sponsoring clinical trial NCT03159299?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03159299 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.