Evaluation of an Intervention Based on Cell Phones
Evaluation of the Effect of an Intervention Based on Cell Phones on Glycemic Control in Adults With Type 2 Diabetes Mellitus
1 other identifier
interventional
88
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Oct 2012
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedMarch 24, 2014
March 1, 2014
4 months
March 4, 2014
March 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycated hemoglobin
Glycated hemoglobin is obtained from a blood sample at the beginning of the study and 3 months later.
Basal and 3 months
Secondary Outcomes (5)
Low Density Lipoprotein
Basal and 3 months
High Density Lipoprotein
Basal and 3 months
Cholesterol
Basal and 3 months
Self-efficacy
Basal and 3 months
Physical activity
Basal and 3 months
Study Arms (2)
Voice messages
ACTIVE COMPARATORThis group receive voice messages to reinforce given information about diet, physical activity, glycemic index
Messages
PLACEBO COMPARATORThis group received voice messages with fun facts.
Interventions
Eligibility Criteria
You may qualify if:
- type 2 diabetes mellitus \> 10 years
- Glycated hemoglobin \>7%
You may not qualify if:
- Take insulin regularly
- Pregnant woman
- Woman who expected to be pregnant the next 6 months
- hrs creatinine \< 30 ml/minute
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social
Cuernavaca, Morelos, 62450, Mexico
Related Publications (3)
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.
PMID: 12619168BACKGROUNDLiang 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.
PMID: 21392066BACKGROUNDCole-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.
PMID: 20354039BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario E Flores Aldanda, PhD
Instituto Nacional de Salud Pública
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jefe del Departamento de Epidemiología Nutricional. Centro de Investigación en Nutrición y Salud
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 24, 2014
Study Start
October 1, 2012
Primary Completion
February 1, 2013
Study Completion
May 1, 2013
Last Updated
March 24, 2014
Record last verified: 2014-03