- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01012206
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits (SELFH)
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Umeå, Sverige, SE-901 87
- Umea University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria for SELFH intervention study:
- age and gender adjusted body mass index (BMI) > 25
- born in 1995-1998
- living in or nearby the northern city of Umea, Sweden
Exclusion Criteria for SELFH intervention study:
- no chronic disease that could influence metabolic parameters
- no attention deficit disorders
- no access to internet
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Control group
Children in control group obtained no lifestyle counseling (intervention).
|
|
Aktiv komparator: 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.
|
Children in the intervention group participated in an intervention program regarding food habits and physical activity.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Body Mass Index
Tidsram: Two years
|
Two years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Food intake
Tidsram: Two years
|
Two years
|
Physical activity
Tidsram: Two years
|
Two years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christel Larsson, PhD, Department of Food and Nutrition, Umeå university.
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 05-088M
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