NCT00458224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2007

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

8.2 years

First QC Date

April 7, 2007

Last Update Submit

June 2, 2015

Conditions

OverweightObesityChild

Keywords

overweightobesitychild

Outcome Measures

Primary Outcomes (1)

  • Effect of BMI from a specific family oriented program

    1, 3 and 5 years

Study Arms (1)

Parental counseling

EXPERIMENTAL

Life style counseling

Behavioral: parental counseling

Interventions

parental counselingBEHAVIORAL

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

Also known as: Life style counseling
Parental counseling

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset innlandet HF, Department of Pediatrics

Lillehammer, N-2629, Norway

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Trond Markestad, Md. PhD

    Sykehuset Innlandet HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

April 7, 2007

First Posted

April 10, 2007

Study Start

February 1, 2007

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

NO(1)