Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits (SELFH)
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|ClinicalTrials.gov Identifier: NCT01012206|
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : September 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Intervention regarding food habits and physical activity.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
No Intervention: Control group
Children in control group obtained no lifestyle counseling (intervention).
Active Comparator: Intervention group
Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity.
Behavioral: Intervention regarding food habits and physical activity.
Children in the intervention group participated in an intervention program regarding food habits and physical activity.
- Body Mass Index [ Time Frame: Two years ]
- Food intake [ Time Frame: Two years ]
- Physical activity [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012206
|Umeå, Sweden, SE-901 87|
|Principal Investigator:||Christel Larsson, PhD||Department of Food and Nutrition, Umeå university.|