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

NCT03159299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2020-04-27

Study results available
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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

Interventions

BEHAVIORAL

Yo Puedo + mHealth

This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months.

Sponsors & Collaborators

  • Universidad Iberoamericana

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Robin Whittemore, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2019-04-28
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159299 on ClinicalTrials.gov