DiabetesNCT01174381
The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases
A study testing lifestyle modification in people with Diabetes and Hypertension, run by University of Kelaniya at 1 site in Sri Lanka.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Diabetes, Hypertension, Stroke
- What is being tested?
- lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSri Lanka
- Study dates
- Aug 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults between 25-60 years
Who cannot join
- adults with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes, Hypertension, Stroke, Ischemic Heart Disease
- Being tested
- lifestyle modification
- Keywords
- Non communicable disease, Lifestyle Modification, Community Based organization, community based study
- Medical subject headings
- Diabetes Mellitus, Hypertension, Stroke, Myocardial Ischemia, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modificationBehavioural
Lifestyle modification for six months
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Experimental | Lifestyle modification for behavior change related to NCD prevention Receives: Behavioral: lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who change their lifestyle characteristics related to NCDs
Measured: 6 months
Secondary outcomes (1)
Proportion of participants with decrease in Body Mass Index following lifestyle modification programme
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kelaniya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, T M E Dabrera, University of Kelaniya
- Investigators
- Thushani M Dabrera, MBBS, MSc, Principal investigator, University of Kelaniya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174381
- Sponsor's protocol ID
- PGIM/AC/4
- Status last verified
- May 2015
- First submitted
- 30 Jul 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01174381
- Acronym / sponsor ID
- PGIM/AC/4
- Conditions
- Diabetes, Hypertension, Stroke, Ischemic Heart Disease
- Keywords
- Non communicable disease, Lifestyle Modification, Community Based organization, community based study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University of KelaniyaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Experimental | Behavioral: lifestyle modificationLifestyle modification for behavior change related to NCD prevention |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adults between 25-60 years
Key exclusion criteria (1 listed)
- adults with psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle modificationLifestyle modification for six months | Behavioural | Lifestyle modification |
Primary outcome
Proportion of participants who change their lifestyle characteristics related to NCDs
Time frame: 6 months
1 secondary outcome
Proportion of participants with decrease in Body Mass Index following lifestyle modification programme
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thushani M Dabrera, MBBS, MSc principal investigator
University of Kelaniya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle modification in people with Diabetes and Hypertension, run by University of Kelaniya at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who change their lifestyle characteristics related to NCDs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.