search
Back to results

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
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring overweight, obesity, child

Eligibility Criteria

5 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
April 7, 2007
Last Updated
June 2, 2015
Sponsor
Sykehuset Innlandet HF
Collaborators
The Royal Norwegian Ministry of Health
search

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

We'll reach out to this number within 24 hrs