Evaluation of an Intervention Based on Cell Phones

Study Overview
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Brief Summary
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The aim of the study was to assess the effect of an individualized intervention based on cell phones to improve glycemic control in patients with type 2 diabetes attending Epidemiology Research Unit in Cuernavaca, Morelos. Mexico

Detailed Description
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In this study before randomization, the participants received workshops on diet, physical activity, glycemic index of foods. Bandura´s theoretical model was used in the voice messages sent to the intervention group.

Official Title
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Evaluation of the Effect of an Intervention Based on Cell Phones on Glycemic Control in Adults With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Voice messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus > 10 years Glycated hemoglobin >7% Exclusion Criteria: Take insulin regularly Pregnant woman Woman who expected to be pregnant the next 6 months 24 hrs creatinine < 30 ml/minute

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Voice messages<br>This group receive voice messages to reinforce given information about diet, physical activity, glycemic index | Behavioral: Voice messages<br>* Voice messages reinforced with self-efficacy<br>|
| Placebo Comparator: Messages<br>This group received voice messages with fun facts. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin | Glycated hemoglobin is obtained from a blood sample at the beginning of the study and 3 months later. | Basal and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Density Lipoprotein | Low Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later. | Basal and 3 months | 
| High Density Lipoprotein | High Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later. | Basal and 3 months | 
| Cholesterol | Cholesterol is obtained from a blood sample at the beginning of the study and 3 months later. | Basal and 3 months | 
| Self-efficacy | Self-efficacy questionnaire is divided into a diet´s self-efficacy questionnaire and physical activity´s self-efficacy questionnaire. People can obtained low self-efficacy status or high self-efficacy status | Basal and 3 months | 
| Physical activity | A triaxial accelerometer was used, colocated on the hip and the participants were supposed to use it 7 days for a minimal of 10 hours per day | Basal and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellular phones, Type 2 diabetes, Glycated hemoglobin, glycemic control