Trial Outcomes & Findings for Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City (NCT NCT03159299)

NCT ID: NCT03159299

Last Updated: 2020-04-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: Baseline, 3, 6 months
• Results posted on: 2020-04-27

Participant Flow

Participant milestones

Measure	Yo Puedo This group will receive the modified Yo Puedo + mHealth program. 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.	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.
Overall Study STARTED	26	21
Overall Study COMPLETED	24	20
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Yo Puedo n=26 Participants This group will receive the modified Yo Puedo + mHealth program. 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.	Wait-list Control n=21 Participants 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.	Total n=47 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 9.2 • n=5 Participants	56.8 years STANDARD_DEVIATION 8.3 • n=7 Participants	55.4 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mexico	26 participants n=5 Participants	21 participants n=7 Participants	47 participants n=5 Participants
Marital Status	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3, 6 months

Population: Intention to treat analysis included all observations for all relevant time points used in the calculation.

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.

Outcome measures

Measure	Yo Puedo n=26 Participants This group will receive the modified Yo Puedo + mHealth program. 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.	Wait-list Control n=21 Participants 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.
Change in Hemoglobin A1C From Baseline 3 months	7.85 percentage HbA1c Standard Deviation 1.40	8.76 percentage HbA1c Standard Deviation 1.40
Change in Hemoglobin A1C From Baseline 6 months	7.56 percentage HbA1c Standard Deviation 1.50	8.05 percentage HbA1c Standard Deviation 1.51
Change in Hemoglobin A1C From Baseline Change from baseline	-1.76 percentage HbA1c Standard Deviation 0.30	-0.97 percentage HbA1c Standard Deviation 0.33
Change in Hemoglobin A1C From Baseline Baseline	9.32 percentage HbA1c Standard Deviation 1.44	9.09 percentage HbA1c Standard Deviation 1.58

SECONDARY outcome

Timeframe: Baseline

Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Dietary intake will be evaluated by a two-day diet history

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Dietary intake will be evaluated by a two-day diet history

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Dietary intake will be evaluated by a two-day diet history

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion, about 1 year

Rates of recruitment will be collected by researchers to evaluate feasibility.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Yo Puedo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Wait-list Control

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Yo Puedo n=26 participants at risk This group will receive the modified Yo Puedo + mHealth program. 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.	Wait-list Control n=21 participants at risk 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.
Endocrine disorders Hypoglycemia	0.00% 0/26 • Approximately one year Data were collected on episodes of hypoglycemia or hyperglycemia at data collection times (3 and 6 months). There were 10 minor adverse events of hyperglycemia or hypoglycemia possibly or unrelated to study. There was one major adverse event of hypoglycemia requiring emergency room treatment of participant in the control group, unlikely related to the study. All treatment-related and non-treatment related adverse events are being reported.	4.8% 1/21 • Number of events 1 • Approximately one year Data were collected on episodes of hypoglycemia or hyperglycemia at data collection times (3 and 6 months). There were 10 minor adverse events of hyperglycemia or hypoglycemia possibly or unrelated to study. There was one major adverse event of hypoglycemia requiring emergency room treatment of participant in the control group, unlikely related to the study. All treatment-related and non-treatment related adverse events are being reported.

Other adverse events

Measure	Yo Puedo n=26 participants at risk This group will receive the modified Yo Puedo + mHealth program. 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.	Wait-list Control n=21 participants at risk 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.
Endocrine disorders Hypoglycemic	19.2% 5/26 • Number of events 5 • Approximately one year Data were collected on episodes of hypoglycemia or hyperglycemia at data collection times (3 and 6 months). There were 10 minor adverse events of hyperglycemia or hypoglycemia possibly or unrelated to study. There was one major adverse event of hypoglycemia requiring emergency room treatment of participant in the control group, unlikely related to the study. All treatment-related and non-treatment related adverse events are being reported.	9.5% 2/21 • Number of events 2 • Approximately one year Data were collected on episodes of hypoglycemia or hyperglycemia at data collection times (3 and 6 months). There were 10 minor adverse events of hyperglycemia or hypoglycemia possibly or unrelated to study. There was one major adverse event of hypoglycemia requiring emergency room treatment of participant in the control group, unlikely related to the study. All treatment-related and non-treatment related adverse events are being reported.
Endocrine disorders hyperglycemia	11.5% 3/26 • Number of events 3 • Approximately one year Data were collected on episodes of hypoglycemia or hyperglycemia at data collection times (3 and 6 months). There were 10 minor adverse events of hyperglycemia or hypoglycemia possibly or unrelated to study. There was one major adverse event of hypoglycemia requiring emergency room treatment of participant in the control group, unlikely related to the study. All treatment-related and non-treatment related adverse events are being reported.	0.00% 0/21 • Approximately one year Data were collected on episodes of hypoglycemia or hyperglycemia at data collection times (3 and 6 months). There were 10 minor adverse events of hyperglycemia or hypoglycemia possibly or unrelated to study. There was one major adverse event of hypoglycemia requiring emergency room treatment of participant in the control group, unlikely related to the study. All treatment-related and non-treatment related adverse events are being reported.

Additional Information

Robin Whittemore, PhD

Yale School of Nursing

Phone: 203-737-2351

Email: robin.whittemore@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place