Use of Computers to Prevent Metabolic Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Computer based Metabolic Syndrome educational program


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 CBMP<br>CBMP: Computer based Metabolic syndrome program | Other: Computer based Metabolic Syndrome educational program<br>* Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program<br>* Other names: CBMP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of participants with increase in Knowledge, Attitude and Practice scores |  | 3 months | 
| Frequency of participants with increase in treatment adherence scores |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of participants with increase in Satisfaction to Medical Care |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Hypertension, Hypercholesterolemia, Obesity