NCT01713465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 24, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

October 22, 2012

Last Update Submit

October 23, 2012

Conditions

Keywords

DiabetesHypertensionHypercholesterolemiaObesity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Frequency of participants with increase in Satisfaction to Medical Care

    3 months

Study Arms (1)

1 CBMP

EXPERIMENTAL

CBMP: Computer based Metabolic syndrome program

Other: Computer based Metabolic Syndrome educational program

Interventions

Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program

Also known as: CBMP
1 CBMP

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults age 30 years and above, agreeing to participate in the study available for follow-up interview.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Public Health informatics, AIPH

Bhubaneshwar, Odisha, 751002, India

RECRUITING

Related Publications (2)

  • 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.

    PMID: 16931210BACKGROUND
  • 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.

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusHypertensionHypercholesterolemiaObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ashish Joshi, MD,PhD, MPH

    UNMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish Joshi, MD,PhD, MPH

CONTACT

Shruti Mehta, PGDHHM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 24, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

October 24, 2012

Record last verified: 2012-10

Locations