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

NCT03159299 | Completed Results DMC

• 1 other identifier: 1511016854
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are:

1. 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. 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

mHealth; Hispanic/Latinos; Diabetes Self-Management Education

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1C From Baseline

  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.

  Baseline, 3, 6 months

Secondary Outcomes (18)

• Baseline Systolic and Diastolic Blood Pressure

  Baseline

• Change in Baseline Systolic and Diastolic Blood Pressure From Baseline

  3 months

• Change in Baseline Systolic and Diastolic Blood Pressure From Baseline

  6 months

• Body Mass Index (BMI)

  Baseline

• Change in Body Mass Index (BMI) From Baseline

  3 months

Other Outcomes (5)

• Satisfaction With Program

  6 months

• Rate of Recruitment

  through study completion, about 1 year

• Attrition

  through study completion, about 1 year

Study Arms (2)

Yo Puedo

EXPERIMENTAL

This group will receive the modified Yo Puedo + mHealth program.

Behavioral: Yo Puedo + mHealth

Wait-list Control

NO INTERVENTION

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.

Interventions

Yo Puedo + mHealth BEHAVIORAL

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.

Yo Puedo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Universidad Iberoamericana: collaborator

Study Sites (1)

Yale School of Nursing

Orange, Connecticut, 06477, United States

Location

Related Publications (1)

• Whittemore R, Vilar-Compte M, De La Cerda S, Delvy R, Jeon S, Burrola-Mendez S, Pardo-Carrillo M, Lozano-Marrufo A, Perez-Escamilla R. inverted exclamation markSi, Yo Puedo Vivir Sano con Diabetes! A Self-Management Randomized Controlled Pilot Trial for Low-Income Adults with Type 2 Diabetes in Mexico City. Curr Dev Nutr. 2020 Apr 14;4(5):nzaa074. doi: 10.1093/cdn/nzaa074. eCollection 2020 May.

  PMID: 32368713 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Robin Whittemore, PhD
• Organization: Yale School of Nursing

robin.whittemore@yale.edu

203-737-2351

Study Officials

• Robin Whittemore, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 18, 2017
• Study Start: May 8, 2017
• Primary Completion: April 28, 2019
• Study Completion: June 30, 2019
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: April 2020 - December 2020
• Access Criteria: Contact the Principal Investigator

Locations

US (1)