Metabolic SyndromeNCT01713465
Use of Computers to Prevent Metabolic Syndrome
A study testing Computer based Metabolic Syndrome educational program in people with Metabolic Syndrome, run by Asian Institute of Public Health at 1 site in India.
Trial summary
The objective of the proposed study is to design and evaluate a touch screen computer based multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse Indian settings including urban, rural and slum in the State of Bhubaneshwar. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Computer based Metabolic Syndrome educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2012to Apr 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults age 30 years and above, agreeing to participate in the study available for follow-up interview.
Who cannot join
- mental and physical challenge that makes it difficult to use the touch based computer program nonavailability for telephone follow-up involvement in other clinical trials or protocols related to Metabolic Syndrome.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Center for Public Health informatics, AIPH
Bhubaneswar, Odisha, 751002
Shruti Mehta, PGDHHM, 8763717844, drshruti.mehta1@gmail.com
About this study
Official title: An Innovative Informatics Platform to Deliver a Multidimensional Intervention to Prevent and Manage Metabolic Syndrome
The objective of the proposed study is to design and evaluate a touch screen computer based multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse Indian settings including urban, rural and slum in the State of Bhubaneshwar. The study objective is to improve metabolic syndrome related knowledge, attitude and practices among individuals using the proposed interactive, bilingual computer based educational program.
Read the detailed description
The rising prevalence of overweight and obesity has a direct correlation with increasing prevalence of hypertension, dyslipidemia, type2 diabetes mellitus (T2DM), Metabolic Syndrome (MetS), and Cardiovascular diseases (CVD). Most of the previous studies in India have been cross sectional nature and have looked at prevalence of Metabolic Syndrome (MetS. Despite the clinical and public health importance of this phenomenon, not enough work has been carried out so far to study and remedy this situation. A computer based interactive and bilingual system is proposed to improve Metabolic syndrome related knowledge, attitudes and practices among individuals living in urban, rural and slum settings of Bhubaneswar, India. We propose to enroll 750 individuals and the eligible study participants will be randomly assigned to either the intervention (computer based MetS Program CBMP) or control (Printed Educational Material, PEM) groups. The study participants will be followed at days 30, 60 and 90 days following the baseline visit. The primary outcomes include change in knowledge, attitudes and practices and secondary outcomes include improvement in quality of life and increase satisfaction to medical care.
- Conditions
- Metabolic Syndrome
- Being tested
- Computer based Metabolic Syndrome educational program
- Keywords
- Diabetes, Hypertension, Hypercholesterolemia, Obesity
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Hypertension, Hypercholesterolemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer based Metabolic Syndrome educational programOther
Also called CBMP
Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program
| Study group | Role | What they receive |
|---|---|---|
| 1 CBMP | Experimental | CBMP: Computer based Metabolic syndrome program Receives: Other: Computer based Metabolic Syndrome educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of participants with increase in Knowledge, Attitude and Practice scores
Measured: 3 months
Frequency of participants with increase in treatment adherence scores
Measured: 3 months
Secondary outcomes (1)
Frequency of participants with increase in Satisfaction to Medical Care
Measured: 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 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashish Joshi, Asian Institute of Public Health
- Investigators
- Ashish Joshi, MD,PhD, MPH, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713465
- Sponsor's protocol ID
- GIA22012
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2012
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finkelstein J, Joshi A, Hise MK. Association of physical activity and renal function in subjects with and without metabolic syndrome: a review of the Third National Health and Nutrition Examination Survey (NHANES III). Am J Kidney Dis. 2006 Sep;48(3):372-82. doi: 10.1053/j.ajkd.2006.05.013.
PubMed 16931210Joshi A, Mehta S, Talati K, Grover A. Protocol for an experimental study design to evaluate computer-enabled intervention to prevent and manage metabolic syndrome. BMJ Open. 2013 Mar 1;3(3):e002163. doi: 10.1136/bmjopen-2012-002163.
PubMed 23454666
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Informatics Platform to Deliver a Multidimensional Intervention to Prevent and Manage Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01713465
- Acronym / sponsor ID
- GIA22012
- Conditions
- Metabolic Syndrome
- Keywords
- Diabetes, Hypertension, Hypercholesterolemia, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Asian Institute of Public HealthUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 24 Oct 2012 (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 objective of the proposed study is to design and evaluate a touch screen computer based multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse Indian settings including urban, rural and slum in the State of Bhubaneshwar. The study objective is to improve metabolic syndrome related knowledge, attitude and practices among individuals using the proposed interactive, bilingual computer based educational program.
Detailed description
The rising prevalence of overweight and obesity has a direct correlation with increasing prevalence of hypertension, dyslipidemia, type2 diabetes mellitus (T2DM), Metabolic Syndrome (MetS), and Cardiovascular diseases (CVD). Most of the previous studies in India have been cross sectional nature and have looked at prevalence of Metabolic Syndrome (MetS. Despite the clinical and public health importance of this phenomenon, not enough work has been carried out so far to study and remedy this situation. A computer based interactive and bilingual system is proposed to improve Metabolic syndrome related knowledge, attitudes and practices among individuals living in urban, rural and slum settings of Bhubaneswar, India. We propose to enroll 750 individuals and the eligible study participants will be randomly assigned to either the intervention (computer based MetS Program CBMP) or control (Printed Educational Material, PEM) groups. The study participants will be followed at days 30, 60 and 90 days following the baseline visit. The primary outcomes include change in knowledge, attitudes and practices and secondary outcomes include improvement in quality of life and increase satisfaction to medical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 CBMP | Experimental | Other: Computer based Metabolic Syndrome educational programCBMP: Computer based Metabolic syndrome program |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults age 30 years and above, agreeing to participate in the study available for follow-up interview.
Key exclusion criteria (1 listed)
- mental and physical challenge that makes it difficult to use the touch based computer program nonavailability for telephone follow-up involvement in other clinical trials or protocols related to Metabolic Syndrome.
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 |
|---|---|---|
| Computer based Metabolic Syndrome educational programAlso: CBMPIndividuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program | Other | 1 CBMP |
Primary outcome
Frequency of participants with increase in Knowledge, Attitude and Practice scores
Time frame: 3 months
Frequency of participants with increase in treatment adherence scores
Time frame: 3 months
1 secondary outcome
Frequency of participants with increase in Satisfaction to Medical Care
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
- Background: PubMed 16931210Finkelstein J, Joshi A, Hise MK. Association of physical activity and renal function in subjects with and without metabolic syndrome: a review of the Third National Health and Nutrition Examination Survey (NHANES III). Am J Kidney Dis. 2006 Sep;48(3):372-82. doi: 10.1053/j.ajkd.2006.05.013.
- Derived from this study: PubMed 23454666Joshi A, Mehta S, Talati K, Grover A. Protocol for an experimental study design to evaluate computer-enabled intervention to prevent and manage metabolic syndrome. BMJ Open. 2013 Mar 1;3(3):e002163. doi: 10.1136/bmjopen-2012-002163.
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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.
Ashish Joshi, MD,PhD, MPH principal investigator
UNMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer based Metabolic Syndrome educational program in people with Metabolic Syndrome, run by Asian Institute of Public Health at 1 site in India.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2012. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashish Joshi, MD,PhD, MPH (4435706018, ashish1875@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of participants with increase in Knowledge, Attitude and Practice scores (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT01713465, which also lists 2 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 Oct 2012.