Could consumption of Sri Lankan traditional rice compared to normal rice, reduce obesity or factors contributing to obesity in children?

1. Study Setting -The study will be conducted at the Department of biochemistry, Faculty of medical sciences, University of Sri Jayewardenepura and Lady Ridgeway Hospital for Children (LRH), Colombo 08, Sri Lanka.

2. Randomization a) Minimisation method, which is a type of covariate adaptive randomization, will be utilized to allocate the participants to intervention and control groups. Minimisation method used to minimize the imbalance across age and sex factors in intervention and control group Age and sex will be the covariates considered. The first participant will be randomly assigned to either the treatment or control group. Each subsequent participant will be assigned to study groups (intervention and control) using minimisation method to ensure balance in age and sex covariates. Minimisation will be carried out using the free software Minim. (Altman and Bland, 2005). In minim interface we will create two treatment groups as intervention and control. Sex and age will be our two covariates(factor). For sex factor two categories will be there as male and female. For age five categories as10,12,13,14,15 yrs

b) Allocation Concealment The allocation will be performed by a medical officer who is not involved with this research and Minim, a free software, will be used for minimisation. The allocation sequence will be concealed until intervention assignment, ensuring investigators and participants cannot predict or influence the allocation.

1. Intervention The intervention group will be given two types of Sri Lankan traditional rice: low GI, a white (Rathel/ Kahawanu), and a red variety (Pachchaperumal). At each visit, participants will receive 4?kg of red rice and 3?kg of white rice (7?kg total), sufficient to cover the 13-week period. (02 visits) They are instructed to consume provided traditional rice as one main meal for five days per week for six months (white 2 days and red 3 days) with their standard therapy.

The quantity will not be restricted for the research purposes .They are advisable to consume the amount according to the guidelines given by the Pediatric consultant at the clinic visits.
The compliance of rice consumption will be assessed each week via phone call interviews. A tracking sheet will be provided to the intervention group to indicate rice consumption with the amount. Parents /guardians of the participants will be trained to fill up the sheet accurately and advised to use this rice only for the intended recipient.

The consumption pattern of other food items will be recorded via food frequency and dietary patterns questionnaire. It will be administered at the first contact point (week 0) and the mid- point (week 13) last contact point(week 26)

1. Control group The control group will be requested to consume the normal diet as generally advised or home-cooked meals with their standard therapy.

Both the interventional and control groups will continue with other general advice and recommendations given by the paediatric endocrine consultant on their clinic visits. Advice on portion size of carbohydrates, healthy snacks, how to avoid high calory food, importance of physical activity, limiting junk , fried, sweet food based on each child’s requirement.The ongoing normal treatment regimen designed for them by the consultant will be continuous and will not be affected by the research intervention.

1. The outcome assessors are trained medical officers and nursing officers who are blinded to the group allocation and study objectives. They are responsible for taking anthropometric measurements, blood pressure readings, and assisting with biochemical sample processing. 5.2. Participants are assessed at three main time points:

Baseline (Week 0) – before intervention begins Midpoint (Week 13) – after 3 months Endpoint (Week 26) – after 6 month

• Children of both sexes
• Children between 10 to 14 years of age
• Children with a body mass index (BMI) of over the 95th centile for age and sex (BMI between +2 SD t+3 SD, WHO normative data)
• Normotensive blood pressure less than 95th centile for height, sex, and age

• Children with extreme obesity (BMI more than +3 SD WHO normative data)
• Children with Pre- diabetes or diabetes (HbA1C ?5.7%)
• Children with Total cholesterol ?200 mg/ dL, low-density lipoprotein ?130 mg/dL
• Children with Hypothyroidism
• Children with any other known endocrine disorders.
• Children with chronic diseases