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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174381
• Other study ID #: PGIM/AC/4
• Status: Completed
• Phase: N/A
• First received: July 30, 2010
• Last updated: May 26, 2015
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2015
• Source: University of Kelaniya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sri Lanka: Ministry of Healthcare & Nutrition
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• adults between 25-60 years

Exclusion Criteria:

• adults with psychiatric disorders

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes
• Hypertension
• Ischemic Heart Disease
• Myocardial Ischemia
• Stroke

Intervention

Behavioral:
• lifestyle modification
Lifestyle modification for six months

Locations

Country	Name	City	State
Sri Lanka	University of Kelaniya	Ragama	Western

Sponsors (1)

Lead Sponsor	Collaborator
University of Kelaniya

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who change their lifestyle characteristics related to NCDs		6 months	No
Secondary	Proportion of participants with decrease in Body Mass Index following lifestyle modification programme		6 months	No