Prevention of Permanent Obesity in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Trond Markestad, Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00458224
First received: April 7, 2007
Last updated: January 22, 2013
Last verified: January 2013

April 7, 2007
January 22, 2013
February 2007
December 2014   (final data collection date for primary outcome measure)
Effect of BMI from a specific family oriented program [ Time Frame: 1, 3 and 5 years ] [ Designated as safety issue: No ]
Effect of BMI from a specific family oriented program
Complete list of historical versions of study NCT00458224 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of Permanent Obesity in Children
Prevention of Permanent Obesity in Children

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Overweight
  • Obesity
  • Child
Behavioral: parental counseling
Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training
  • Experimental: Life style counseling
    Group intervention for parents with advice on diet, exercise and other life style behavior
    Intervention: Behavioral: parental counseling
  • No Intervention: No contact
    No contact other than recording of weight and BMI development
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI > 18.9
  • Age 5-7 years
  • Residing in Oppland county

Exclusion criteria:

  • chronic disease
Both
5 Years to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00458224
150089
No
Trond Markestad, Sykehuset Innlandet HF
Sykehuset Innlandet HF
The Royal Norwegian Ministry of Health
Principal Investigator: Trond Markestad, Md. PhD Sykehuset Innlandet HF
Sykehuset Innlandet HF
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP