- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713465
Use of Computers to Prevent Metabolic Syndrome
October 23, 2012 updated by: Ashish Joshi, Asian Institute of Public Health
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
750
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Orissa
-
Bhubaneshwar, Orissa, India, 751002
- Recruiting
- Center for Public Health informatics, AIPH
-
Contact:
- Shruti Mehta, PGDHHM
- Phone Number: 8763717844
- Email: drshruti.mehta1@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults age 30 years and above, agreeing to participate in the study available for follow-up interview.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 CBMP
CBMP: Computer based Metabolic syndrome program
|
Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Frequency of participants with increase in Knowledge, Attitude and Practice scores
Time Frame: 3 months
|
3 months
|
|
Frequency of participants with increase in treatment adherence scores
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Frequency of participants with increase in Satisfaction to Medical Care
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ashish Joshi, MD,PhD, MPH, UNMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Joshi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
April 1, 2013
Study Registration Dates
First Submitted
October 22, 2012
First Submitted That Met QC Criteria
October 23, 2012
First Posted (Estimate)
October 24, 2012
Study Record Updates
Last Update Posted (Estimate)
October 24, 2012
Last Update Submitted That Met QC Criteria
October 23, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIA22012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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