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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: Completed NA study of Type 2 Diabetes Mellitus, sponsored by Yale University.
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 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change in A1C from baseline to 6 months is the result of the Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis that was used. HbA1c was measured from finger stick blood sample.
Conditions Studied
Interventions
- BEHAVIORAL Yo Puedo + mHealth
Study Locations (1)
Connecticut
- Yale School of Nursing - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
What the finished NCT03159299 record still lists
NCT03159299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03159299's enrollment target sits among peer trials
47 81st of 130 higher than 50 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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