Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.

Objectives:

• To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
• To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
• To evaluate the role and significance of including parents in an intervention program for obesity prevention.
• To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.

Randomization:

Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.

Intervention groups:

• parent's group- only parents will take part at the intervention program.
• Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.

Methods:

• The study will be consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in all 3 groups) at months 0, 3, 12 and 24.
• Height, weight, fat mass and waist circumference will be measured at 0, 3, 12 and 24 month. Height and weight of parents will also be measured at these visits.
• Physical examination will be performed at 0, 3, 12 and 24 month.
• Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
• Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNFα will be performed at 0, 3, 12 and 24 month.

Inclusion criteria

• Children aged 5-10 years old
• BMI in 85-98 percentile
• Both parents signing informed consent form

Exclusion criteria

• Chronic disease or chronic use of medication
• Incapability to perform all study procedure