Type 2 DiabetesNCT02441023
Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes
A study testing Nutritional therapy and education and Nutritional therapy in people with Type 2 Diabetes, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the effectiveness of nutrition therapy in combination with education in diabetes using a multimedia application for improving indicators of metabolic control in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Nutritional therapy and education and Nutritional therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2013to Dec 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes, following ADA \& WHO criteria
- Without severe marco or microvascular complications of diabetes
- HbA1c > 6.5% and <13.0%
Who cannot join
- Inability to or unwillnigness to access the multimedia or to follow dietary recommendations
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Investigación en Epidemiología Clínica, Hospital Regional 1 Carlos Mac Gregor Sanchez Navarro, IMSS
Mexico City, Mexico City, 03100
About this study
Official title: Nutritional Therapy and Education With a Multimedia Application in the Metabolic Control of Patients With Type 2 Diabetes. Randomized Clinical Trial
The purpose of this study is to evaluate the effectiveness of nutrition therapy in combination with education in diabetes using a multimedia application for improving indicators of metabolic control in patients with type 2 diabetes.
Read the detailed description
Randomized clinical trial. Subjects with type 2 diabetes from three Family Medicine Units (primary care), with HbA1c >6.5% and <13.0%, without advanced macro or microvascular complications of diabetes.
Two arms: the experimental group with nutrition therapy plus education in diabetes through a multimedia application. The application had seven modules: Introduction, nutrition, physical exercise in diabetes, myths and truths on diabetes, metabolic control parameters, knowing diabetes, complications of diabetes. The control group received only usual nutrition therapy.
A monthly follow up during the first 7 months and then bimonthly, until 21 months of total follow up, with reinforcement in each visit of nutrition and other non-pharmacological therapy, with control on weight and blood pressure. Laboratory studies included HbA1c, lipids profile, creatinine and albuminuria, performed at 7, 14 and 21 months. Results were provided to both the patient and his family physician, so modification in drug treatment if needed, were performed.
- Conditions
- Type 2 Diabetes
- Being tested
- Nutritional therapy and education, Nutritional therapy
- Keywords
- type 2 diabetes mellitus, nutritional therapy, health education, self-management, multimedia
- Medical subject headings
- Diabetes Mellitus, Type 2, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional therapy and educationBehavioural
- Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes.
- Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials.
Nutritional therapyBehavioural
Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association Standards for medical care in diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional therapy and education | Experimental | 1. Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes.
2. Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials. Receives: Behavioral: Nutritional therapy and education; Behavioral: Nutritional therapy |
| Nutritional Therapy | No intervention | Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic control
metabolic control which is evaluated by measuring the change in glycosylated hemoglobin
Measured: 21 months
Secondary outcomes (2)
Lipids profile
Lipid profile includes the evaluation of total cholesterol, triglycerides, HDL-c and LDL-c
Measured: 21 months
Body mass index (BMI)
It is evaluated by measuring the weight in relation to height
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Lubia Velázquez López, Coordinación de Investigación en Salud, Mexico
- Investigators
- Lubia Velazquez, M. Sc.,, Principal investigator, Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441023
- Sponsor's protocol ID
- 2012-C01-181015
- Status last verified
- May 2015
- First submitted
- 6 May 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Provide nutritional and educational measures in long-term in diabetes care.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Therapy and Education With a Multimedia Application in the Metabolic Control of Patients With Type 2 Diabetes. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02441023
- Acronym / sponsor ID
- 2012-C01-181015
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes mellitus, nutritional therapy, health education, self-management, multimedia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 May 2015 (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 purpose of this study is to evaluate the effectiveness of nutrition therapy in combination with education in diabetes using a multimedia application for improving indicators of metabolic control in patients with type 2 diabetes.
Detailed description
Randomized clinical trial. Subjects with type 2 diabetes from three Family Medicine Units (primary care), with HbA1c >6.5% and <13.0%, without advanced macro or microvascular complications of diabetes.
Two arms: the experimental group with nutrition therapy plus education in diabetes through a multimedia application. The application had seven modules: Introduction, nutrition, physical exercise in diabetes, myths and truths on diabetes, metabolic control parameters, knowing diabetes, complications of diabetes. The control group received only usual nutrition therapy.
A monthly follow up during the first 7 months and then bimonthly, until 21 months of total follow up, with reinforcement in each visit of nutrition and other non-pharmacological therapy, with control on weight and blood pressure. Laboratory studies included HbA1c, lipids profile, creatinine and albuminuria, performed at 7, 14 and 21 months. Results were provided to both the patient and his family physician, so modification in drug treatment if needed, were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional therapy and education | Experimental | Behavioral: Nutritional therapy and education, Behavioral: Nutritional therapy1. Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes. 2. Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials. |
| Nutritional Therapy | No intervention | –Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of type 2 diabetes, following ADA \& WHO criteria
- Without severe marco or microvascular complications of diabetes
- HbA1c > 6.5% and <13.0%
Key exclusion criteria (1 listed)
- Inability to or unwillnigness to access the multimedia or to follow dietary recommendations
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 |
|---|---|---|
| Nutritional therapy and education1. Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes. 2. Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials. | Behavioural | Nutritional therapy and education |
| Nutritional therapyNutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association Standards for medical care in diabetes. | Behavioural | Nutritional therapy and education |
Primary outcome
Metabolic control
Time frame: 21 months
metabolic control which is evaluated by measuring the change in glycosylated hemoglobin
2 secondary outcomes
Lipids profile
Time frame: 21 months
Body mass index (BMI)
Time frame: 21 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 9 Feb 2016.
- Individual participant dataSharing planned: Yes. Provide nutritional and educational measures in long-term in diabetes care.
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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.
Lubia Velazquez, M. Sc., principal investigator
Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional therapy and education and Nutritional therapy in people with Type 2 Diabetes, run by Coordinación de Investigación en Salud, 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 3 inclusion and 1 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 9 Feb 2016. 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. 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?
Metabolic control (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2016.