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Completed

NCT Number: NCT02094846

Evaluation of an Intervention Based on Cell Phones

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

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Key information

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social

Cuernavaca, Morelos, 62450, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voice messages

Behavioral

Voice messages reinforced with self-efficacy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Cholesterol

    Time frame: Basal and 3 months

    Cholesterol is obtained from a blood sample at the beginning of the study and 3 months later.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Salud Publica, Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 24, 2014
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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