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Original TRDS for trail "Weight reduction program for obese women in a general practice in suburban Sri Lanka" created on Apr 22, 2013


SLCTR Registration Number


Date of Registration


The date of last modification

Apr 22, 2013


View original TRDS



Application Summary


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

None


Trial Details


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

Uncontrolled


Assignment

Crossover


Purpose

Prevention


Study Phase


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

  1. Females with age between 18 to 65 years
  2. Body mass index between 27.5 and 40 kg/m2
  3. Residing in Ragama and receiving primary care at the Faculty of Medicine, Family Medicine Clinic

Exclusion criteria

  1. Unwilling to attempt weight loss
  2. Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease and ongoing substance abuse
  3. Taking prescription medications for: diabetes, hypertension, dyslipidaemia
  4. Psychiatric disorders requiring antipsychotics or multiple medications
  5. Body weight change > 10 kg in the preceding 3 months
  6. Pregnant, planning to become pregnant, or lactating less than six months
  7. 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



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information


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/

Secondary study sponsor (If any)







Trial Completion details


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


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results