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Use of Computers to Prevent Metabolic Syndrome

This study is currently recruiting participants.
Verified October 2012 by Asian Institute of Public Health
Sponsor:
Information provided by (Responsible Party):
Ashish Joshi, Asian Institute of Public Health
ClinicalTrials.gov Identifier:
NCT01713465
First received: October 22, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Metabolic Syndrome
 Other: Computer based Metabolic Syndrome educational program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: An Innovative Informatics Platform to Deliver a Multidimensional Intervention to Prevent and Manage Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asian Institute of Public Health:

Primary Outcome Measures:
  • Frequency of participants with increase in Knowledge, Attitude and Practice scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Frequency of participants with increase in treatment adherence scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of participants with increase in Satisfaction to Medical Care [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: March 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 CBMP
CBMP: Computer based Metabolic syndrome program
 Other: Computer based Metabolic Syndrome educational program
Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program
Other Name: CBMP

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713465

Contacts
Contact: Ashish Joshi, MD,PhD, MPH 4435706018 ashish1875@gmail.com
Contact: Shruti Mehta, PGDHHM 8763717844 drshruti.mehta1@gmail.com

Locations
India
Center for Public Health informatics, AIPH Recruiting
Bhubaneshwar, Orissa, India, 751002
Contact: Shruti Mehta, PGDHHM     8763717844     drshruti.mehta1@gmail.com    
Sponsors and Collaborators
Asian Institute of Public Health
Investigators
Principal Investigator: Ashish Joshi, MD,PhD, MPH UNMC
  More Information

Publications:

Responsible Party: Ashish Joshi, Assistant Professor, Asian Institute of Public Health
ClinicalTrials.gov Identifier: NCT01713465     History of Changes
Other Study ID Numbers: GIA22012
Study First Received: October 22, 2012
Last Updated: October 23, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Asian Institute of Public Health:
Diabetes
Hypertension
Hypercholesterolemia
Obesity

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013