Evaluation of an Intervention Based on Cell Phones

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094846
• Other study ID #: Evaluation with cell phones
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: March 20, 2014
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Voice messages
Voice messages reinforced with self-efficacy

Locations

Country	Name	City	State
Mexico	Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social	Cuernavaca	Morelos

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiol Rev. 2010;32:56-69. doi: 10.1093/epirev/mxq004. Epub 2010 Mar 30. Review. — View Citation

Liang X, Wang Q, Yang X, Cao J, Chen J, Mo X, Huang J, Wang L, Gu D. Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. Diabet Med. 2011 Apr;28(4):455-63. doi: 10.1111/j.1464-5491.2010.03180.x. — View Citation

Oh JA, Kim HS, Yoon KH, Choi ES. A telephone-delivered intervention to improve glycemic control in type 2 diabetic patients. Yonsei Med J. 2003 Feb;44(1):1-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin	Glycated hemoglobin is obtained from a blood sample at the beginning of the study and 3 months later.	Basal and 3 months	No
Secondary	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	No
Secondary	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	No
Secondary	Cholesterol	Cholesterol is obtained from a blood sample at the beginning of the study and 3 months later.	Basal and 3 months	No
Secondary	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	No
Secondary	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	No

External Links

•   Effectiveness of mobile and internet intervention in patients with obese type 2 diabetes