Evaluation of an Intervention Based on Cell Phones

March 20, 2014 updated by: Mario Efraín Flores Aldana, Instituto Nacional de Salud Publica, Mexico

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62450
        • Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: Basal and 3 months
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
Time Frame: Basal and 3 months
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
Time Frame: Basal and 3 months
High Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later.
Basal and 3 months
Cholesterol
Time Frame: Basal and 3 months
Cholesterol is obtained from a blood sample at the beginning of the study and 3 months later.
Basal and 3 months
Self-efficacy
Time Frame: 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
Basal and 3 months
Physical activity
Time Frame: 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
Basal and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Salud Publica, Mexico

Investigators

  • Principal Investigator: Mario E Flores Aldanda, PhD, Instituto Nacional de Salud Publica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evaluation with cell phones

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Voice messages

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe