Weight reduction program for obese women in a general practice in suburban Sri Lanka
- Conditions
- Obesity
- Registration Number
- SLCTR/2013/010
- Lead Sponsor
- Faculty of Medicine, University of Kelaniya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.]<br>
- Secondary Outcome Measures
Name Time Method Changes in <br>1. Blood pressure <br>2. Fasting blood glucose <br>3. Lipid profile <br>4. Attitudes <br>5. Behavioural changes <br><br>4 and 5 to be assessed using focus group discussions. [At baseline and at the end of each 6 month stage]<br>