NCT01174381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

July 30, 2010

Last Update Submit

May 26, 2015

Conditions

DiabetesHypertensionStrokeIschemic Heart Disease

Keywords

Non communicable diseaseLifestyle ModificationCommunity Based organizationcommunity based study

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants who change their lifestyle characteristics related to NCDs

    6 months

Secondary Outcomes (1)

  • Proportion of participants with decrease in Body Mass Index following lifestyle modification programme

    6 months

Study Arms (1)

Lifestyle modification

EXPERIMENTAL

Lifestyle modification for behavior change related to NCD prevention

Behavioral: lifestyle modification

Interventions

lifestyle modificationBEHAVIORAL

Lifestyle modification for six months

Lifestyle modification

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults between 25-60 years

You may not qualify if:

  • adults with psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kelaniya

Ragama, Western Province, 0094, Sri Lanka

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionStrokeMyocardial IschemiaNoncommunicable Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thushani M Dabrera, MBBS, MSc

    University of Kelaniya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 3, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

SR(1)