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The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases

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ClinicalTrials.gov Identifier: NCT01174381
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the MOH area, Ragama and measure the effectiveness of the programme.

Condition or disease Intervention/treatment
Diabetes Hypertension Stroke Ischemic Heart Disease Behavioral: lifestyle modification

Detailed Description:
Sri Lanka as a developing nation needs to identify feasible and cost effective measures to face the epidemic of NonCommunicable Diseases(NCDs) in the future. Experiences gained over many years in the developed countries can be of great value in planning and implementing NCD prevention and control activities in the developing countries Results from many studies have emphasized the fact that merely providing risk reduction measures for clinically high-risk people in health service settings would have only a limited impact in the whole country. On the other hand, if the population as a whole were to be targeted, even a modest risk factor and healthy lifestyle change would potentially have a huge public impact.This study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the MOH area, Ragama and measure the effectiveness of the programme. Outcome measures are process indicators, as measured by change in the dietary patterns, alcohol and tobacco consumption and physical activity. Short term outcome indicators would be blood pressure and anthropometric measurements. The long term outcome indicators such as morbidity and mortality due to NCD will not be measured as this will be a short term study.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases: A Community Based Intervention Study Among 25-60 Year Olds
Study Start Date : August 2010
Primary Completion Date : January 2011
Study Completion Date : February 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: Lifestyle modification
Lifestyle modification for behavior change related to NCD prevention
Behavioral: lifestyle modification
Lifestyle modification for six months


Outcome Measures

Primary Outcome Measures :
  1. Proportion of participants who change their lifestyle characteristics related to NCDs [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Proportion of participants with decrease in Body Mass Index following lifestyle modification programme [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults between 25-60 years

Exclusion Criteria:

  • adults with psychiatric disorders
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174381


Locations
Sri Lanka
University of Kelaniya
Ragama, Western, Sri Lanka, 0094
Sponsors and Collaborators
University of Kelaniya
Investigators
Principal Investigator: Thushani M Dabrera, MBBS, MSc University of Kelaniya
More Information

Responsible Party: T M E Dabrera, Doctor, University of Kelaniya
ClinicalTrials.gov Identifier: NCT01174381     History of Changes
Other Study ID Numbers: PGIM/AC/4
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by T M E Dabrera, University of Kelaniya:
Non communicable disease
Lifestyle Modification
Community Based organization
community based study

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases