Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: Yale University

 
Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City 
 
NCT # 03159299 
 
October 17, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY OBJECTIVES 
 
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 program instructors, participants) and preliminary efficacy 
of Yo Puedo!+mHealth in adults with T2D in Mexico City. We will use a randomized, controlled 
pilot study design in which 60 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), waist 
circumference (WC), blood pressure (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. 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. 
 
DESIGN 
We will use a randomized, controlled pilot study design in which 60 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. 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. Those in the control group will be 
invited to participate in the program after completion of the 6-month data collection. We will re-
consent control group participants who chose to participate in the program after the 6-month data 
collection to have data collected one more time, approximately 3 months after the first class. 
Participants will be consented for this additional data collection in person at the last session of 
classes or prior to the data collection session itself. We will conduct interviews with the program 
instructors, 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 Sistema de Protección Social en Salud in Mexico. Individuals who obtain health care at these 
clinics are covered by public health insurance (Seguro Popular), and the services they get 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.  
 
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) six 

interactive group-based sessions (plus an initial orientation session) led by the program instructors 
on T2D self-management that is culturally relevant and at a low health literacy level (Yo Puedo! 
protocol adapted for Mexican context; see Table 1); b) 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 one way text messaging 
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. All text messages sent will initially be stored in the text messaging 
platform but will be archived to the REDcap database for subsequent data analysis. Participants in 
this group will also receive blood glucose monitors and will be instructed on how to use them as a 
part of the instruction provided in the Yo Puedo curriculum. The in-person component will be 6 
weeks; daily text messaging will be for 6 months.  
 
Participants will be randomized to a treatment condition in a 1:1 allocation ratio to one of the two 
treatment conditions using a computer-generated, block randomization procedure. Sequentially 
numbered opaque sealed envelopes will be used to conceal the allocation determination. The RA 
will inform participants about their treatment condition and protocol. After a group of 5 participants 
have been randomized to the Yo Puedo! + mHealth condition, the program will start. Within one 
week, participants will start the group sessions provided by the program instructors. The content 
and procedures in all sessions will be documented. Approximately 10% of sessions will be attended 
by one of the site Co-Is to evaluate protocol fidelity. The CHWs/MAs will remind participants about 
upcoming sessions at the end of a current session and will send a text or call participants the day 
before their next session. Attendance will be recorded. Written content from missed group sessions 
will be given to participants who will be asked to review at home and clarify questions with the 
program instructors. Follow-up data will be collected at 3 and 6 months.   
 
At the end of the study, the program instructors, and select clinic personnel will be interviewed 
to identify successful and unsuccessful elements of implementing the protocol. Strategies for scale 
up will be identified. In addition, all participants will be interviewed upon completion of their 6 month 
data collection about their experience and satisfaction with the program. These interviews will be 
conducted by trained RA’s who have not participated in any of the intervention protocol. We will 
carefully record any implementation issues.  
 
Efficacy data will be collected at the clinic by a trained RA, blinded to participant group assignment 
and includes clinical (A1C, BMI, WC, BP), T2D self-management, dietary intake, physical activity, 
and self-efficacy data.  All of this data will be collected three times, at baseline, 2-3 months, and 6 
month follow-up. We will also collect data on depressive symptoms and food security at all three 
data collection time points.  A1C is our primary outcome and will be measured using standard 
disposable analysis methods. BMI will be calculated according to the formula, BMI = kg/m2 using a 
calibrated electronic scale and a portable stadiometer. WC will also be recorded using standard 
measurement practices. Systolic and diastolic BP will be measured according to practice standards. 
Two readings separated by 1 minute will be averaged. We will also collect data on change in 
medical status, medication and dosage via the medical record.  
 
Self-management will be measured by the Summary of Diabetes Self-Care Activities 
questionnaire, a multi-dimensional 12-item scale with items on general diet, specific diet, monitoring 
blood glucose, foot care, and smoking. Reliability and validity have been established in Spanish-
speaking adults. This self-report questionnaire was used successfully in the initial Yo Puedo! study. 
 
Dietary intake will also be evaluated by a one-day diet history.35 While there is no gold 
standard for self-report of dietary intake, the validity of Spanish dietary recall has been established. 
This diet history guide captures time, location, type of food and preparation, and amount consumed 
in past 24 hours. Calories, %fat intake, and fruit and vegetable intake will be calculated. We will 

also assess diet intake with a brief modified version of a food frequency questionnaire which asks 
about how often a variety of foods was eaten in the past month, including culture specific foods. We 
will include a question regarding food label usage at the end of this questionnaire as the Yo Puedo 
curriculum teaches how to read food labels and emphasizes their use.  
   Physical activity will also be measured by accelerometer, using the Actigraph Actigraphy, a 3-
axial accelerometer. The advantages of this accelerometer are wrist placement, continuous wear, 
water resistance and high data storage capacity. Wearing motion sensors day and night has been 
shown to increase adherence. Accelerometers estimate PA by measuring body movement and can 
capture frequency, duration and intensity of PA. Units of acceleration are expressed in meters per 
second squared and transformed into counts per second/minute/day. Cut-points converting counts 
into moderate-vigorous physical activity have been established (> 1535 counts = moderate PA; 
3960 counts = vigorous PA). Both count data and cut-point data per day/week will be used in the 
analysis. Non-wear time will be calculated using established procedures and considered missing 
data. Three-axial accelerometers demonstrate excellent reliability with no evidence to suggest 
differences in brand or type of sensor. Participants will be asked to wear the accelerometer 
continuously for 1 week at each wave of data collection (baseline, 2-3 months, and 6 months). We 
will also assess physical activity with the Global Physical Activity Questionnaire developed by the 
World Health Organization.  It is a 16-item questionnaire that assesses physical activity and 
sedentary behavior that has established reliability and validity.  
 
Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale 
specific to T2D self-management self-efficacy. Items include confidence in exercise, interpreting 
blood glucose levels, and following dietary recommendations.  Reliability and validity have been 
established in Spanish-speaking adults. This questionnaire was used successfully in the initial Yo 
Puedo! study.  
 
Food Security will be measured using a version of the Latin American and Caribbean Food 
Security Scale (ELCSA) modified for use in urban older adults. This validated questionnaire 
contains 8 items that assess financially based food insecurity in households. It includes items 
related to the frequency at which a household has not been able to access enough food in the last 3 
months. This version specifically modifies the questions for better comprehension in older urban 
Mexican adults of low socioeconomic status, which matches the target population of this study. An 
additional question to assess diabetes-related food insecurity will also be included. 
     Health information will be collected in a form which asks about any clinic visits, emergency 
room visits, episodes of hypoglycemia, diabetes-related health symptoms, medications, other health 
diagnoses, and A1C and blood pressure results in the previous 3 months.We will also collect data 
on participant demographics (age, gender, race/ethnicity, income) and depressive symptoms. We 
will use the Patient Health Questionnaire-8 (PHQ-8) to evaluate depressive symptoms, a well-
established measure, with excellent reliability and validity in English and Spanish-speaking adults.  
 
STATISTICAL ANALYSIS PLAN 
To evaluate the preliminary efficacy of the program, initially the sample and variables will be 
described using frequency distributions and appropriate summary statistics. Additionally, the 2 
groups will be compared to make certain that randomization procedures were adequate. If any 
baseline variables differ by group assignment, they will be included as covariates in subsequent 
analyses. The hypothesis that adults with T2D who receive the Yo Puedo! + mHealth will 
demonstrate better outcomes than adults with T2D in the control condition will be tested using 
Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis. While it is likely that 
significant main effects may not be found for all variables due to the sample size, identification of 
trends of significance (e.g., p<.10) and effect sizes will be possible. The results of analyses of the 
clinical outcomes of A1C and BP will require control for the impact of medication usage and dosage 
change (e.g., change in medications or dosage or no change, increased levels or not, and 
decreased levels or not).