N/A
Completed N=47
Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
Source: ClinicalTrials.gov NCT03159299 ↗Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Apr 2020
Primary outcomePrimary: Change in Hemoglobin A1C From Baseline — -1.76; -0.97; 9.32; 9.09 percentage HbA1c — p=<0.15
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1C From Baseline |
-1.76; -0.97; 9.32; 9.09; 7.85; 8.76 | <0.15 |
| SECONDARY Baseline Systolic and Diastolic Blood Pressure |
— | — |
| SECONDARY Change in Baseline Systolic and Diastolic Blood Pressure From Baseline |
— | — |
| SECONDARY Body Mass Index (BMI) |
— | — |
| SECONDARY Change in Body Mass Index (BMI) From Baseline |
— | — |
| SECONDARY Diabetes Self-management |
— | — |
| SECONDARY Change in Diabetes Self-management From Baseline |
— | — |
| SECONDARY Dietary Intake |
— | — |
| SECONDARY Change in Dietary Intake From Baseline |
— | — |
| SECONDARY Physical Activity |
— | — |
| SECONDARY Change in Physical Activity From Baseline |
— | — |
| SECONDARY Diabetes Self-Efficacy |
— | — |
| SECONDARY Change in Diabetes Self-Efficacy From Baseline |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03159299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.