Prevention of Permanent Obesity in Children
Primary Purpose
Overweight, Obesity, Child
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
parental counseling
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring overweight, obesity, child
Eligibility Criteria
Inclusion Criteria:
- BMI > 18.9
- Age 5-7 years
- Residing in Oppland county
Exclusion criteria:
- chronic disease
Sites / Locations
- Sykehuset innlandet HF, Department of Pediatrics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parental counseling
Arm Description
Life style counseling
Outcomes
Primary Outcome Measures
Effect of BMI from a specific family oriented program
Secondary Outcome Measures
Full Information
NCT ID
NCT00458224
First Posted
April 7, 2007
Last Updated
June 2, 2015
Sponsor
Sykehuset Innlandet HF
Collaborators
The Royal Norwegian Ministry of Health
1. Study Identification
Unique Protocol Identification Number
NCT00458224
Brief Title
Prevention of Permanent Obesity in Children
Official Title
Prevention of Permanent Obesity in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
The Royal Norwegian Ministry of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the county of Oppland, Norway, questionnaires addressing physical and mental health and socioeconomic status is issued to all (1960) families who meet for the pre-school assessment at the public health clinics in 2007. Particularly growth, physical activity and diet is addressed.
Families who have children with a BMI >18.9, which corresponds to BMI>30, and living in selected municipalities in the county are invited to participate in a 5 year intervention program in order to avoid future overweight conditions in children. Similarly overweight children from the rest of the county serve as controls.
Detailed Description
Background: Intervention programs to limit or reduce weight in severely obese adults and adolescents are rarely successful. In the present study intervention is aimed at moderately overweight children of 6 years.
Families in 7 municipalities who have children with BMI >18.9 are invited to a group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training. The families are invited to meet in groups times the first year, two times the second and one time the third year. According to personal interest the families are also invited to meet with the nurse between each of the the above gatherings.
The children are examined by a pediatrician before entry and after 1, 2, 3 and 5 years with specific focus on height and weight. No blood studies are routinely done.
BMI development will be related to BMIs in the family, mother's weight increase in pregnancy, socioeconomic background, general health, psychological factors scored through the Strengths And Difficulties Questionnaire, and compliance with the program. Furthermore, the results are compared to similarly overweight children from the counties who are not invited to participate in the intervention program. The results are obtained through the routine health follow-up programs in school.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Child
Keywords
overweight, obesity, child
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parental counseling
Arm Type
Experimental
Arm Description
Life style counseling
Intervention Type
Behavioral
Intervention Name(s)
parental counseling
Other Intervention Name(s)
Life style counseling
Intervention Description
Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training
Primary Outcome Measure Information:
Title
Effect of BMI from a specific family oriented program
Time Frame
1, 3 and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 18.9
Age 5-7 years
Residing in Oppland county
Exclusion criteria:
chronic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trond Markestad, Md. PhD
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset innlandet HF, Department of Pediatrics
City
Lillehammer
ZIP/Postal Code
N-2629
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Prevention of Permanent Obesity in Children
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