Use of Computers to Prevent Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Computer based Metabolic Syndrome educational program
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome focused on measuring Diabetes, Hypertension, Hypercholesterolemia, Obesity
Eligibility Criteria
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.
Sites / Locations
- Center for Public Health informatics, AIPHRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 CBMP
Arm Description
CBMP: Computer based Metabolic syndrome program
Outcomes
Primary Outcome Measures
Frequency of participants with increase in Knowledge, Attitude and Practice scores
Frequency of participants with increase in treatment adherence scores
Secondary Outcome Measures
Frequency of participants with increase in Satisfaction to Medical Care
Full Information
NCT ID
NCT01713465
First Posted
October 22, 2012
Last Updated
October 23, 2012
Sponsor
Asian Institute of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT01713465
Brief Title
Use of Computers to Prevent Metabolic Syndrome
Official Title
An Innovative Informatics Platform to Deliver a Multidimensional Intervention to Prevent and Manage Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Public Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Diabetes, Hypertension, Hypercholesterolemia, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 CBMP
Arm Type
Experimental
Arm Description
CBMP: Computer based Metabolic syndrome program
Intervention Type
Other
Intervention Name(s)
Computer based Metabolic Syndrome educational program
Other Intervention Name(s)
CBMP
Intervention Description
Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program
Primary Outcome Measure Information:
Title
Frequency of participants with increase in Knowledge, Attitude and Practice scores
Time Frame
3 months
Title
Frequency of participants with increase in treatment adherence scores
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Frequency of participants with increase in Satisfaction to Medical Care
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashish Joshi, MD,PhD, MPH
Phone
4435706018
Email
ashish1875@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shruti Mehta, PGDHHM
Phone
8763717844
Email
drshruti.mehta1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashish Joshi, MD,PhD, MPH
Organizational Affiliation
UNMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Public Health informatics, AIPH
City
Bhubaneshwar
State/Province
Orissa
ZIP/Postal Code
751002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shruti Mehta, PGDHHM
Phone
8763717844
Email
drshruti.mehta1@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
16931210
Citation
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.
Results Reference
background
PubMed Identifier
23454666
Citation
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.
Results Reference
derived
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Use of Computers to Prevent Metabolic Syndrome
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