Use of Computers to Prevent Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

An Innovative Informatics Platform to Deliver a Multidimensional Intervention to Prevent and Manage Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713465
• Other study ID #: GIA22012
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2012
• Last updated: October 23, 2012
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2012
• Source: Asian Institute of Public Health
• Contact: Ashish Joshi, MD,PhD, MPH
• Phone: 4435706018
• Email: ashish1875[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical 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. The study objective is to improve metabolic syndrome related knowledge, attitude and practices among individuals using the proposed interactive, bilingual computer based educational program.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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

Locations

Country	Name	City	State
India	Center for Public Health informatics, AIPH	Bhubaneshwar	Orissa

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Public Health

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of participants with increase in Knowledge, Attitude and Practice scores		3 months	No
Primary	Frequency of participants with increase in treatment adherence scores		3 months	No
Secondary	Frequency of participants with increase in Satisfaction to Medical Care		3 months	No