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Effectiveness of intensive lifestyle modification program aimed at weight reduction of obese females conducted in a primary care setting in Ragama
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SLCTR Registration Number
SLCTR/2013/010
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Effectiveness of intensive lifestyle modification program aimed at weight reduction of obese females conducted in a primary care setting in Ragama
Public Title of Trial
Weight reduction program for obese women in a general practice in suburban Sri Lanka
Disease or Health Condition(s) Studied
Obesity
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P212/12/2012 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Is an intensive lifestyle modification programme aimed at weight reduction of effective in obese females attending a primary care setting in suburban Sri Lanka?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Crossover
Purpose
Prevention
Study Phase
Not Available
Intervention(s) planned
Blood samples will be obtained from all participants for the screening for the following: diabetes mellitus dyslipidaemia, thyroid disease. Once enrolled in the study their anthropometric measurements (height, weight, waist circumference, hip circumference) will be monitored monthly.
The study will be conducted in 2 stages.
During the first stage participants will be maintained on standard care which consists of lifestyle advice (exercise and diet) that is given to all obese patients who visit the clinic and their weight will be monitored for a period of 6 months.
The second stage includes a further 6 months where the participants are invited to participate in an exercise program which includes introduction of Cognitive-Behavioural Therapy (CBT) based lifestyle modification program. The following will be introduced: 1. Individual sessions with the principal investigator for the assessment of physical fitness and level of exercise that they can engage in. 2. Incorporating exercise in to the daily work schedule 3. Introduction to an activity diary which records the daily energy intake and expenditure (self monitoring) 4. Provision of sample diet sheets and food substitutes 5. Introduction of methods to re-channel negative thought processes to more constructive thoughts (cognitive restructuring) 6. Proactive problem solving and dealing with situations which precipitate cravings (stimulus control and adapting alternative behaviours) 7. Exercise sessions conducted once a week with 10-15 participants in a group by a qualified instructor from the physical education unit of the University of Kelaniya. All sessions will be conducted in the Faculty of Medicine, University of Kelaniya in the presence of an MBBS qualified doctor. 8. Building peer groups who can get together and organise walks in the evenings
Inclusion criteria
Exclusion criteria
Plans to move during the study period (24 months post randomization)
Participants achieving a BMI of 23.5 kg/m2 or becoming pregnant will be excluded.
Primary outcome(s)
1.
Change in weight (kg) waist circumference (cm) and Body Mass Index (BMI in kg/m2) |
[ At baseline and monthly for a period of 12 months. ] |
Secondary outcome(s)
1.
Changes in 1. Blood pressure 2. Fasting blood glucose 3. Lipid profile 4. Attitudes 5. Behavioural changes 4 and 5 to be assessed using focus group discussions. |
[ At baseline and at the end of each 6 month stage ] |
Target number/sample size
50
Countries of recruitment
Sri Lanka
Anticipated start date
2013-04-01
Anticipated end date
2013-08-01
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-01-16
Approval number
P212/12/2012
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
Telephone: | +94-11-2961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
RDN Sumanasekera
Lecturer
Department of Family Medicine,
Faculty of Medicine,
PO Box 6, Thalagolla Road, Ragama.
0773714417
rndeepama@gmail.com
Contact Person for Public Queries
RDN Sumanasekera
Lecturer
Department of Family Medicine,
Faculty of Medicine,
PO Box 6, Thalagolla Road, Ragama.
0773714417
rndeepama@gmail.com
Primary study sponsor/organization
Faculty of Medicine, University of Kelaniya
PO Box 6, Thalagolla Road, Ragama.
+94- 11- 2961000 +94-11-2958337
http://www.kln.ac.lk/medicine/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results