type 2 diabetes (T2D) is a worldwide public health epidemic with persons in low and middle-income countries disproportionately affected. The prevalence of T2D in Mexico is one of the highest in the world and the leading cause of death in the country. Adults with T2D in Mexico have sub-optimal self-management and poor metabolic control. Access to self-management education is limited, particularly for the poor and underserved.
The first aim of the study is to translate an evidence-based DSME program (Yo Puedo!) to the cultural norms, expertise of providers, and systems of care in Seguro Popular clinics in Mexico (provide care to adults with low socioeconomic status). This will be accomplished with focus groups inclusive of a collaborative team of diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians, and nurses, community health workers, and adults with T2D in Mexico City, Mexico. We will also develop and systematically evaluate a theory-based mHealth component (pictorial text-messaging) during this phase eliciting feedback on the cultural relevance and understanding of each text/picture. Content analysis of interviews and text-messaging feedback will result in the Yo Puedo! + mHealth program adapted to the local context.
The second aim of the study is to evaluate the feasibility (process of implementation, fidelity of sessions, attendance, attrition), acceptability (interviews with providers and participants) and preliminary efficacy of Yo Puedo + mHealth in adults with T2D in Mexico City. We will use a randomized, controlled pilot study in which 40 adults with T2D are randomized to the Yo Puedo + mHealth or wait-list control condition with the hypothesis that clinical outcomes (A1C, BMI, blood pressure), T2D self-management, and self-efficacy will be better in Yo Puedo + mHealth participants compared to the control condition at 3 and 6 month follow-up. The primary outcome is A1C. We also hypothesize 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. Mixed methods will be used to analyze the feasibility and acceptability of the program. Efficacy will be evaluated with generalized linear mixed models. This multi-phased analysis will provide important information regarding the potential value of the Yo Puedo! + mHealth program in Mexico City. A sustainable collaboration between Yale, Iberoamericana University, and the Seguro Popular clinics, will be established. This will enhance our future plans for evaluating the program in a full-scale pragmatic clinical trial, and disseminating the program to other clinics in Mexico City and beyond, ultimately improving health outcomes for adults with T2D in Mexico and decreasing societal costs of T2D. We will also learn about the feasibility and acceptability of theory-based pictorial text-messaging in a low health literacy population which has national and international implications.

Public Health Relevance

The purpose of this study is to translate an evidence-based diabetes self-management program that includes theory-based pictorial text-messaging to the cultural norms, expertise of providers, and systems of care in Mexico. We will also evaluate the feasibility, acceptability, and efficacy of the program. Translating an evidence-based program to the Mexican population and context is an efficient way to exchange best practices and more rapidly implement and evaluate innovative programs in resource-poor settings.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21NR015856-01A1
Application #
9110430
Study Section
Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Roof, Rebecca
Project Start
2016-09-26
Project End
2018-07-31
Budget Start
2016-09-26
Budget End
2017-07-31
Support Year
1
Fiscal Year
2016
Total Cost
$228,917
Indirect Cost
$73,645
Name
Yale University
Department
Type
Schools of Nursing
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520