Overview

This trial is active, not recruiting.

Condition obesity
Treatments parent management training - oregon (pmto), motivational interviewing, dynamic group therapy
Sponsor Sykehuset i Vestfold HF
Collaborator St. Olavs Hospital
Start date April 2010
End date May 2013
Trial size 100 participants
Trial identifier NCT01110096, FamilY

Summary

The study compares the effect on BMI of two different treatment options for obesity in childhood. Families with at least one obese child and parent are invited to join the project. The hypothesis is that family camp gives an additional reduction in BMI compared to a less intensive family lifestyle school.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Obese families participate in a two week camp with two years follow-up.
parent management training - oregon (pmto)
Method to help parents and caregivers manage the behavior of the children they are responsible for.
motivational interviewing
Communication method to facilitate behavioral change and empower the parents.
dynamic group therapy
Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.
(Experimental)
Families participate in a four day practical course about lifestyle.
motivational interviewing
Communication method to facilitate behavioral change and empower the parents.

Primary Outcomes

Measure
BMI-SDS
time frame: After 2 years

Secondary Outcomes

Measure
Quality of life
time frame: After 2 years
Physical fitness
time frame: After 2 years
Behaviour
time frame: After 2 years
Blood samples
time frame: After 2 years

Eligibility Criteria

Male or female participants from 7 years up to 11 years old.

Inclusion Criteria: - age 7 to 12 years - BMI > iso-BMI 30 (Coles index) Exclusion Criteria: - syndromatic obesity - obesity related to diseases - local community not involved - child has present follow-up because of obesity in secondary health care - parent has present/planned follow-up because of obesity in secondary health care

Additional Information

Official title Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.
Principal investigator Samira Lekhal, PhD, MD
Description Participants are randomised to two intervention groups: A): Two weeks family camp and two years follow-up as a cooperation with primary health care, private rehabilitation center and specialist health care. B): Four days lifestyle school with two years follow-up as a cooperation with primary health care and specialist health care
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Sykehuset i Vestfold HF.