Clinical trial NCT01713465: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Diabetes
Hypertension
Hypercholesterolemia
Obesity
Lead sponsor: Asian Institute of Public Health
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 750
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Frequency of participants with increase in Knowledge, Attitude and Practice scores
timeFrame: 3 months
measure: Frequency of participants with increase in treatment adherence scores
timeFrame: 3 months
Secondary outcomes:
measure: Frequency of participants with increase in Satisfaction to Medical Care
timeFrame: 3 months
Other outcomes:
Locations:
city: Bhubaneshwar
country: India
facility: Center for Public Health informatics, AIPH
state: Orissa
Study officials:
affiliation: UNMC
name: Ashish Joshi, MD,PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.