Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Randomized, controlled, open, comparative intervention study in 270 children at risk for
      obesity.Patients will be randomly allocated into one of two behavior intervention groups or
      control group in ratio of 1:1:1.The study will 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 al 3 groups) at months 0, 3, 12 and 24.
    

Detailed description: 
      Randomized, controlled, open, comparative intervention study in 270 children at risk for
      obesity.

      Objectives:

        1. To develop an intervention program for obesity prevention in children aged 5-10 years
           old, who are at risk to develop obesity

        2. To compare between the efficacy of two different intervention programs and a control
           group in preventing obesity in the short and the long term.

        3. To evaluate the role and significance of including parents in an intervention program
           for obesity prevention.

        4. 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:

        1. parent's group- only parents will take part at the intervention program.

        2. Parents and children group- both children and parents will take part at the intervention
           program, in two separate sessions.

      Methods:

        1. 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.

        2. 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.

        3. Physical examination will be performed at 0, 3, 12 and 24 month.

        4. Psychological and nutritional questionnaire (depression, quality of life and self
           estimation) will be filled at 0, 3, 12 and 24 month.

        5. 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.
    

Intervention name(s): Parents and children group; Parent's group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 months workshops of parents and children intervention, guided by dietician and phycologist; 3 months workshop of parents intervention, guided by dietician and phycologist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity,prevention,pediatric