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

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ClinicalTrials.gov Identifier: NCT03159299
Recruitment Status : Completed
First Posted : May 18, 2017
Results First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Universidad Iberoamericana
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Yo Puedo + mHealth Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : April 28, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yo Puedo
This group will receive the modified Yo Puedo + mHealth program.
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.

No Intervention: Wait-list Control
This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished.



Primary Outcome Measures :
  1. Change in Hemoglobin A1C From Baseline [ Time Frame: Baseline, 3, 6 months ]
    The change in A1C from baseline to 6 months is the result of the Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis that was used. HbA1c was measured from finger stick blood sample.


Secondary Outcome Measures :
  1. Baseline Systolic and Diastolic Blood Pressure [ Time Frame: Baseline ]
    Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged

  2. Change in Baseline Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: 3 months ]
    Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged

  3. Change in Baseline Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: 6 months ]
    Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged

  4. Body Mass Index (BMI) [ Time Frame: Baseline ]
    A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.

  5. Change in Body Mass Index (BMI) From Baseline [ Time Frame: 3 months ]
    A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.

  6. Change in Body Mass Index (BMI) From Baseline [ Time Frame: 6 months ]
    A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.

  7. Diabetes Self-management [ Time Frame: Baseline ]
    Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking

  8. Change in Diabetes Self-management From Baseline [ Time Frame: 3 months ]
    Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking

  9. Change in Diabetes Self-management From Baseline [ Time Frame: 6 months ]
    Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking

  10. Dietary Intake [ Time Frame: Baseline ]
    Dietary intake will be evaluated by a two-day diet history

  11. Change in Dietary Intake From Baseline [ Time Frame: 3 months ]
    Dietary intake will be evaluated by a two-day diet history

  12. Change in Dietary Intake From Baseline [ Time Frame: 6 months ]
    Dietary intake will be evaluated by a two-day diet history

  13. Physical Activity [ Time Frame: Baseline ]
    Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.

  14. Change in Physical Activity From Baseline [ Time Frame: 3 months ]
    Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.

  15. Change in Physical Activity From Baseline [ Time Frame: 6 months ]
    Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.

  16. Diabetes Self-Efficacy [ Time Frame: Baseline ]
    Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.

  17. Change in Diabetes Self-Efficacy From Baseline [ Time Frame: 3 months ]
    Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.

  18. Change in Diabetes Self-Efficacy From Baseline [ Time Frame: 6 months ]
    Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.


Other Outcome Measures:
  1. Satisfaction With Program [ Time Frame: 6 months ]
    This measure will be used to evaluate the acceptability of the Yo Puedo program. Participants will be given a short survey and interview about their experience and satisfaction with the program.

  2. Rate of Recruitment [ Time Frame: through study completion, about 1 year ]
    Rates of recruitment will be collected by researchers to evaluate feasibility.

  3. Attrition [ Time Frame: through study completion, about 1 year ]
    This will be collected by researchers to evaluate feasibility. The number of participants who do not complete the study interventions and the reasons why will be recorded by study personnel.

  4. Protocol Implementation [ Time Frame: through study completion, about 1 year ]
    This will be collected by researchers to evaluate feasibility. The CHWs will complete a Protocol Implementation Form after each session that documents attendance, length of the session, content of session, protocol implementation, and any deviation from protocol implementation

  5. Fidelity of Yo Puedo Sessions [ Time Frame: through study completion, about 1 year ]
    This will be collected by researchers to evaluate feasibility. A study Co-Investigator will observe 10% of sessions to evaluate fidelity of Yo Puedo sessions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159299


Locations
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United States, Connecticut
Yale School of Nursing
Orange, Connecticut, United States, 06477
Sponsors and Collaborators
Yale University
Universidad Iberoamericana
Investigators
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Principal Investigator: Robin Whittemore, PhD Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03159299    
Other Study ID Numbers: 1511016854
First Posted: May 18, 2017    Key Record Dates
Results First Posted: April 27, 2020
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: April 2020 - December 2020
Access Criteria: Contact the Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
mHealth
Hispanic/Latinos
Diabetes Self-Management Education
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases