Prevention of Permanent Obesity in Children

NCT ID: NCT00458224

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2015-04-30

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.

Conditions

Overweight; Obesity; Child

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Parental counseling

Life style counseling

Group Type: EXPERIMENTAL

parental counseling

Intervention Type: BEHAVIORAL

Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training

Interventions

parental counseling

Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training

Intervention Type: BEHAVIORAL

Other Intervention Names

Life style counseling

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• chronic disease

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role: collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role: lead

Responsible Party

Trond Markestad

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trond Markestad, Md. PhD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Innlandet HF

Locations

Sykehuset innlandet HF, Department of Pediatrics

Lillehammer, , Norway

Countries

Norway

Other Identifiers

150089

Identifier Type: -

Identifier Source: org_study_id