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

This mixed-method design study will be accomplished in two phases with an interdisciplinary,
bi-national collaboration between the Yale School of Nursing, the Yale School of Public
Health, the Iberoamericana University in Mexico City, and up to 10 Seguro Popular clinics to
evaluate the adapted DSME program for adults with T2D in Mexico City.

Phase 1: While the Yo Puedo! program addresses some of the needs of Mexican adults with type
2 diabetes - interactive health education for low health literacy, Spanish language materials
and video novellas, and activities to enhance self-efficacy, the program was developed to
address the needs of Latino immigrants in the U.S, who are from different Latin countries.
The program needs to be adapted to Mexican adults with respect to personal beliefs about
disease causation, cultural health practices, self-care practices of type 2 diabetes, and
issues regarding access to care. This aim will be accomplished by using an interpretive and
participatory method with a collaborative team of diabetes experts in the US and Mexico,
Seguro Popular clinic administrators, physicians, and nurses, and adults with T2D in Mexico
City, Mexico. In focus groups and interviews, the study team will explore how the cultural
context, family, and health system shape beliefs and practices related to T2D. Access and
familiarity with texting technology to identify potential barriers to using a text-messaging
mHealth program will also be explored. These results will inform any modifications to the Yo
Puedo! curriculum that may need to be made before Phase 2 can begin.

Phase 2: A randomized, controlled pilot study design will be used in which 40 adults with T2D
are randomized to the Yo Puedo + mHealth or wait-list control condition with the hypothesis
that clinical (A1C, BMI, BP), T2D self-management, and self-efficacy outcomes will be greater
in Yo Puedo + mHealth participants compared to the wait-list control condition at 3 and 6
month follow-up. It is also hypothesized 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. Those in the control group will be invited to participate in the program after
completion of the 6-month data collection. Interviews will be conducted with the nurse,
community health worker (CHW), participants, and select clinic personnel to identify
barriers, facilitators, and acceptability of the program from multiple perspectives,
recognizing the complexity of the health care system. Detailed notes on the process of
implementation will be carefully recorded with the purpose of identifying successful and
unsuccessful components of the program (positive and negative feedback loops in a complex
system).

Setting. The study will be conducted in up to 10 Seguro Popular clinics. These clinics are
part of the Social Protection System in Health in Mexico. Individuals who obtain health care
at these clinics are covered by public health insurance (Seguro Popular), and the services
offered for T2D care include medical visits, referrals to specialists and nutritionist when
needed, laboratory testing, and free medicines. The medical visits include medication
prescription, blood pressure management, lipid monitoring, and eye/foot care. Laboratory
analyses vary from patient to patient but generally includes 3 annual tests of A1C, although
other glucose, urine, and lipids tests are also available. Patients with complications are
referred to specialized health centers. Evidence suggests that the impact of the Seguro
Popular in adults with T2D has been positive.

Interventions. All participants will receive standard T2D care at a Seguro Popular clinic as
described above. The wait-list control condition group will receive a handout on T2D
self-management and the opportunity to participate in the Yo Puedo! + mHealth program at the
completion of 6-month data collection. The Yo Puedo! + mHealth DSME program includes: a) an
initial consultation with the nurse to collaboratively determine goals; b) five interactive
group-based sessions led by the CHW on T2D self-management that is culturally relevant and at
a low health literacy level (Yo Puedo! protocol adapted for Mexican context; c) behavioral
support to collaboratively problem-solve barriers to change; and d) empowerment-based
strategies to facilitate provider-patient communication. The Yo Puedo! program will be
supplemented by 2-way text-messaging capability provided by a web-based platform with privacy
and security rules, which allows for automated and personalized messages and a database to
store all messages. Automated daily text messages will include messages to promote
understanding of T2D self-management, self-efficacy, and adherence to self-management goals.
The in-person component will be 6 weeks; daily text messaging will be for 6 months.

Inclusion Criteria:

Phase 1:

- For provider interviews/focus groups: administrator or health care provider at Seguro
Popular clinic with at least 3 months experience.

- For adult interviews/focus groups: 21-65 years of age and have had T2D for at least
one year

Phase 2:

- Age 21-65 years; receiving care for T2D at a Seguro Popular clinic; diagnosed with T2D
with A1C >8.0% and duration ≤ 5 years; medically stable and safe to exercise; and have
a cell phone (MMS text-messaging will be provided).

Exclusion Criteria:

Phase 2:

- Cognitive impairment, severe untreated clinical depression in the past 6 months, major
cardiac event in past 12 months, uncontrolled blood pressure, resting tachycardia,
renal failure, severe peripheral neuropathy, treatment of T2D with insulin, and
participation in focus groups or interviews.