Back to resultsThe Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases
Primary Purpose
Diabetes, Hypertension, Stroke
Status
Completed
Phase
Not Applicable
Locations
Sri Lanka
Study Type
Interventional
Intervention
lifestyle modification
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes focused on measuring Non communicable disease, Lifestyle Modification, Community Based organization, community based study
Eligibility Criteria
Inclusion Criteria:
- adults between 25-60 years
Exclusion Criteria:
- adults with psychiatric disorders
Sites / Locations
- University of Kelaniya
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle modification
Arm Description
Lifestyle modification for behavior change related to NCD prevention
Outcomes
Primary Outcome Measures
Proportion of participants who change their lifestyle characteristics related to NCDs
Secondary Outcome Measures
Proportion of participants with decrease in Body Mass Index following lifestyle modification programme
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01174381
Brief Title
The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kelaniya
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Stroke, Ischemic Heart Disease
Keywords
Non communicable disease, Lifestyle Modification, Community Based organization, community based study
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle modification
Arm Type
Experimental
Arm Description
Lifestyle modification for behavior change related to NCD prevention
Intervention Type
Behavioral
Intervention Name(s)
lifestyle modification
Intervention Description
Lifestyle modification for six months
Primary Outcome Measure Information:
Title
Proportion of participants who change their lifestyle characteristics related to NCDs
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of participants with decrease in Body Mass Index following lifestyle modification programme
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults between 25-60 years
Exclusion Criteria:
adults with psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thushani M Dabrera, MBBS, MSc
Organizational Affiliation
University of Kelaniya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kelaniya
City
Ragama
State/Province
Western
ZIP/Postal Code
0094
Country
Sri Lanka
12. IPD Sharing Statement
Learn more about this trial
The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases
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