search
Back to results

Evaluation of an Intervention Based on Cell Phones

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Voice messages
Sponsored by
Instituto Nacional de Salud Publica, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Cellular phones, Type 2 diabetes, Glycated hemoglobin, glycemic control

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Voice messages

Messages

Arm Description

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

This group received voice messages with fun facts.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2014
Last Updated
March 20, 2014
Sponsor
Instituto Nacional de Salud Publica, Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT02094846
Brief Title
Evaluation of an Intervention Based on Cell Phones
Official Title
Evaluation of the Effect of an Intervention Based on Cell Phones on Glycemic Control in Adults With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Salud Publica, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Cellular phones, Type 2 diabetes, Glycated hemoglobin, glycemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voice messages
Arm Type
Active Comparator
Arm Description
This group receive voice messages to reinforce given information about diet, physical activity, glycemic index
Arm Title
Messages
Arm Type
Placebo Comparator
Arm Description
This group received voice messages with fun facts.
Intervention Type
Behavioral
Intervention Name(s)
Voice messages
Intervention Description
Voice messages reinforced with self-efficacy
Primary Outcome Measure Information:
Title
Glycated hemoglobin
Description
Glycated hemoglobin is obtained from a blood sample at the beginning of the study and 3 months later.
Time Frame
Basal and 3 months
Secondary Outcome Measure Information:
Title
Low Density Lipoprotein
Description
Low Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later.
Time Frame
Basal and 3 months
Title
High Density Lipoprotein
Description
High Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later.
Time Frame
Basal and 3 months
Title
Cholesterol
Description
Cholesterol is obtained from a blood sample at the beginning of the study and 3 months later.
Time Frame
Basal and 3 months
Title
Self-efficacy
Description
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
Time Frame
Basal and 3 months
Title
Physical activity
Description
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
Time Frame
Basal and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario E Flores Aldanda, PhD
Organizational Affiliation
Instituto Nacional de Salud Pública
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62450
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
12619168
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. doi: 10.3349/ymj.2003.44.1.1.
Results Reference
background
PubMed Identifier
21392066
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.
Results Reference
background
PubMed Identifier
20354039
Citation
Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiol Rev. 2010;32(1):56-69. doi: 10.1093/epirev/mxq004. Epub 2010 Mar 30.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/17881285
Description
Effectiveness of mobile and internet intervention in patients with obese type 2 diabetes

Learn more about this trial

Evaluation of an Intervention Based on Cell Phones

We'll reach out to this number within 24 hrs