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
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Permanent Obesity in Children

Resource links provided by NLM:


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 ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Life style counseling
Group intervention for parents with advice on diet, exercise and other life style behavior
Behavioral: parental counseling
Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training
No Intervention: No contact
No contact other than recording of weight and BMI development

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
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

No publications provided

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: January 22, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Sykehuset Innlandet HF:
overweight
obesity
child

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

ClinicalTrials.gov processed this record on July 29, 2014