Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits (SELFH)
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Purpose
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 | Intervention |
|---|---|
|
Overweight Obesity |
Behavioral: Intervention regarding food habits and physical activity. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits |
- Body Mass Index [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Food intake [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Physical activity [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Enrollment: | 105 |
| Study Start Date: | August 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
Additional Information:
Publications:
| Responsible Party: | Christel Larsson, Professor, Umeå University |
| ClinicalTrials.gov Identifier: | NCT01012206 History of Changes |
| Other Study ID Numbers: | 05-088M |
| Study First Received: | November 10, 2009 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Sweden: Swedish National Council on Medical Ethics |
Keywords provided by Umeå University:
|
Children Overweight Obesity |
Food habits Dietary assessment Physical activity |
Additional relevant MeSH terms:
|
Food Habits Obesity Overweight Habits |
Overnutrition Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013