Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits (SELFH)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intervention regarding food habits and physical activity.
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Children, Overweight, Obesity, Food habits, Dietary assessment, Physical activity
Eligibility Criteria
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
Sites / Locations
- Umeå university
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control group
Intervention group
Arm Description
Children in control group obtained no lifestyle counseling (intervention).
Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity.
Outcomes
Primary Outcome Measures
Body Mass Index
Secondary Outcome Measures
Food intake
Physical activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01012206
Brief Title
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits
Acronym
SELFH
Official Title
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Children, Overweight, Obesity, Food habits, Dietary assessment, Physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children in control group obtained no lifestyle counseling (intervention).
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Intervention regarding food habits and physical activity.
Intervention Description
Children in the intervention group participated in an intervention program regarding food habits and physical activity.
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Food intake
Time Frame
Two years
Title
Physical activity
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christel Larsson, PhD
Organizational Affiliation
Department of Food and Nutrition, Umeå university.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umeå university
City
Umeå
ZIP/Postal Code
SE-901 87
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
19158227
Citation
Waling MU, Larsson CL. Energy intake of Swedish overweight and obese children is underestimated using a diet history interview. J Nutr. 2009 Mar;139(3):522-7. doi: 10.3945/jn.108.101311. Epub 2009 Jan 21.
Results Reference
result
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Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits
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