Type 2 Diabetes MellitusNCT02094846
Evaluation of an Intervention Based on Cell Phones
A study testing Voice messages in people with Type 2 Diabetes Mellitus, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
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 Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Voice messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus > 10 years
- Glycated hemoglobin >7%
Who cannot join
- Take insulin regularly
- Pregnant woman
- Woman who expected to be pregnant the next 6 months
- 24 hrs creatinine < 30 ml/minute
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social
Cuernavaca, Morelos, 62450
About this study
Official title: Evaluation of the Effect of an Intervention Based on Cell Phones on Glycemic Control in Adults With Type 2 Diabetes Mellitus
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
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Voice messages
- Keywords
- Cellular phones, Type 2 diabetes, Glycated hemoglobin, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice messagesBehavioural
Voice messages reinforced with self-efficacy
| Study group | Role | What they receive |
|---|---|---|
| Voice messages | Active comparator | This group receive voice messages to reinforce given information about diet, physical activity, glycemic index Receives: Behavioral: Voice messages |
| Messages | Placebo comparator | This group received voice messages with fun facts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Glycated hemoglobin is obtained from a blood sample at the beginning of the study and 3 months later.
Measured: Basal and 3 months
Secondary outcomes (5)
Low Density Lipoprotein
Low Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later.
Measured: Basal and 3 months
High Density Lipoprotein
High Density Lipoprotein is obtained from a blood sample at the beginning of the study and 3 months later.
Measured: Basal and 3 months
Cholesterol
Cholesterol is obtained from a blood sample at the beginning of the study and 3 months later.
Measured: Basal and 3 months
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
Measured: Basal and 3 months
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
Measured: Basal and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Efraín Flores Aldana, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Mario E Flores Aldanda, PhD, Principal investigator, Instituto Nacional de Salud Pública
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094846
- Sponsor's protocol ID
- Evaluation with cell phones
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12619168Liang 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.
PubMed 21392066Cole-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.
PubMed 20354039
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of an Intervention Based on Cell Phones on Glycemic Control in Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02094846
- Acronym / sponsor ID
- Evaluation with cell phones
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Cellular phones, Type 2 diabetes, Glycated hemoglobin, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voice messages | Active comparator | Behavioral: Voice messagesThis group receive voice messages to reinforce given information about diet, physical activity, glycemic index |
| Messages | Placebo comparator | –This group received voice messages with fun facts. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes mellitus > 10 years
- Glycated hemoglobin >7%
Key exclusion criteria (4 listed)
- Take insulin regularly
- Pregnant woman
- Woman who expected to be pregnant the next 6 months
- 24 hrs creatinine < 30 ml/minute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice messagesVoice messages reinforced with self-efficacy | Behavioural | Voice messages |
Primary outcome
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.
5 secondary outcomes
Low Density Lipoprotein
Time frame: Basal and 3 months
High Density Lipoprotein
Time frame: Basal and 3 months
Cholesterol
Time frame: Basal and 3 months
Self-efficacy
Time frame: Basal and 3 months
Physical activity
Time frame: Basal and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Background: PubMed 12619168Oh 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.
- Background: PubMed 21392066Liang 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.
- Background: PubMed 20354039Cole-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.
- Effectiveness of mobile and internet intervention in patients with obese type 2 diabetesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario E Flores Aldanda, PhD principal investigator
Instituto Nacional de Salud Pública
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice messages in people with Type 2 Diabetes Mellitus, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: Basal and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094846, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.