Evaluation of an Intervention Based on Cell Phones

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Voice messages

• Registration Number: NCT02094846
• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-02
• Study Completion: 2013-05
• Status Verified: 2014-03
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-20
• Last Update Submitted: 2014-03-20
• Study First Posted: 2014-03-24
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voice messages	Voice messages	This group receive voice messages to reinforce given information about diet, physical activity, glycemic index

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin	Basal and 3 months	Glycated hemoglobin is obtained from a blood sample at the beginning of the study and 3 months later.

Secondary Outcome Measures

Name	Time	Method
Physical activity	Basal and 3 months	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
Low Density Lipoprotein	Basal and 3 months	Low Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later.
High Density Lipoprotein	Basal and 3 months	High Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later.
Cholesterol	Basal and 3 months	Cholesterol is obtained from a blood sample at the beginning of the study and 3 months later.
Self-efficacy	Basal and 3 months	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

Trial Locations

Locations (1)

Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social; 🇲🇽 Cuernavaca, Morelos, Mexico