Obesity Clinical Trial
Official title:
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits
The aim is to investigate the development of overweight and obesity from infancy to school
age, and to evaluate an intervention to prevent further development of overweight and
obesity among children.
A follow-up study will be conducted on 267 children and will allow comparison between
children that developed overweight with the ones who did not. Subjects will be requited at
10 years of age from a previous project. These children have been studied when they were
6-18 months old and a follow-up was conducted at 4 years of age. Sixteen percent of the
children were overweight at 4 years of age and retrospective data of e.g. food intake, blood
lipids and anthropometric measurements exists. In the present follow-up data regarding food
and physical activity habits, anthropometric measurements and blood samples of e.g. blood
lipids, IGF1 will be collected.
An intervention study will be conducted on 80-120 overweight children that will be
randomized into one intervention and one control group. An intervention during two years
will encourage long term healthy habits regarding diet and physical activity through group
meetings and supervision. Information about food habits will be collected through
questionnaires, interviews and diaries. Measurement of physical activity and energy
expenditure will be made with Sense Wear and double labeled water, and will be used to
validate reported food intake. Further, anthropometric measurements and blood samples will
be collected.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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