Prevention of Permanent Obesity in Children

This study has been completed.
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: June 2, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Overweight
Obesity
Child
Behavioral: parental counseling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Permanent Obesity in Children

Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Effect of BMI from a specific family oriented program [ Time Frame: 1, 3 and 5 years ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: February 2007
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parental counseling
Life style counseling
Behavioral: parental counseling
Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training
Other Name: Life style counseling

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.

  Eligibility

Ages Eligible for Study:   5 Years to 7 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria:

  • chronic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458224

Locations
Norway
Sykehuset innlandet HF, Department of Pediatrics
Lillehammer, Norway, N-2629
Sponsors and Collaborators
Sykehuset Innlandet HF
The Royal Norwegian Ministry of Health
Investigators
Principal Investigator: Trond Markestad, Md. PhD Sykehuset Innlandet HF
  More Information

Responsible Party: Trond Markestad, Professor, MD, PhD, Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT00458224     History of Changes
Other Study ID Numbers: 150089 
Study First Received: April 7, 2007
Last Updated: June 2, 2015
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Sykehuset Innlandet HF:
overweight
obesity
child

Additional relevant MeSH terms:
Obesity
Overweight
Pediatric Obesity
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 23, 2016