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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Kelaniya.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Kelaniya
ClinicalTrials.gov Identifier:
NCT01174381
First received: July 30, 2010
Last updated: August 3, 2010
Last verified: July 2010
  Purpose

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 Intervention
Diabetes
Hypertension
Stroke
Ischemic Heart Disease
Behavioral: lifestyle modification

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Kelaniya:

Primary Outcome Measures:
  • Proportion of participants who change their lifestyle characteristics related to NCDs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with decrease in Body Mass Index following lifestyle modification programme [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: August 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle modification Behavioral: lifestyle modification
Lifestyle modification for six months

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults between 25-60 years

Exclusion Criteria:

  • adults with psychiatric disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174381

Contacts
Contact: Thushani M Dabrera 0094777730433 thushanidabrera@yahoo.com

Locations
Sri Lanka
University of Kelaniya Not yet recruiting
Ragama, Western, Sri Lanka, 0094
Contact: A Pathmeswaren, MBBS, MS, MD    0094112958166      
Sub-Investigator: A Pathmeswaren, MBBS, MD         
Sponsors and Collaborators
University of Kelaniya
Investigators
Principal Investigator: Thushani M Dabrera, MBBS, MSc University of Kelaniya
  More Information

No publications provided

Responsible Party: T M E Dabrera, University of Kelaniya
ClinicalTrials.gov Identifier: NCT01174381     History of Changes
Other Study ID Numbers: PGIM/AC/4
Study First Received: July 30, 2010
Last Updated: August 3, 2010
Health Authority: Sri Lanka: Ministry of Healthcare & Nutrition

Keywords provided by University of Kelaniya:
Non communicable disease
Lifestyle Modification
Community Based organization
community based study

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

ClinicalTrials.gov processed this record on September 18, 2014