Evaluation of an Intervention Based on Cell Phones

NCT ID: NCT02094846

Last Updated: 2014-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Voice messages

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

Group Type ACTIVE_COMPARATOR

Voice messages

Intervention Type BEHAVIORAL

Voice messages reinforced with self-efficacy

Messages

This group received voice messages with fun facts.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Voice messages

Voice messages reinforced with self-efficacy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role lead

Responsible Party

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Mario Efraín Flores Aldana

Jefe del Departamento de Epidemiología Nutricional. Centro de Investigación en Nutrición y Salud

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario E Flores Aldanda, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Salud Pública

Locations

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

Cuernavaca, Morelos, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 12619168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21392066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20354039 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/17881285

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

Other Identifiers

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Evaluation with cell phones

Identifier Type: -

Identifier Source: org_study_id

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