Family Based Intervention in Childhood obesitY

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Parent Management Training - Oregon (PMTO); Behavioral: Motivational interviewing; Behavioral: Dynamic group therapy

• Registration Number: NCT01110096
• Lead Sponsor: Sykehuset i Vestfold HF

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-26
• Primary Completion: 2013-05
• Study Completion: 2020-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - family camp	Dynamic group therapy	Obese families participate in a two week camp with two years follow-up.
Group A - family camp	Parent Management Training - Oregon (PMTO)	Obese families participate in a two week camp with two years follow-up.
Group A - family camp	Motivational interviewing	Obese families participate in a two week camp with two years follow-up.
Group B - family lifestyle school	Motivational interviewing	Families participate in a four day practical course about lifestyle.

Primary Outcome Measures

Name	Time	Method
BMI-SDS	After 2 years	Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.

Secondary Outcome Measures

Name	Time	Method
Quality of life	After 2 years	Questionnaire for children and parent
Blood samples	After 2 years	Improvement in spesific blood tests with relevance to metabolic syndrome after 2 years intervention? Blood is biobanked at baseline and after 2 years.
Physical fitness	After 2 years	Six minutes walk test for children and parents.
Behaviour	After 2 years	Evaluating effect of intervention on risk for psyciatric disorders.

Trial Locations

Locations (2)

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority; 🇳🇴 Tønsberg, Norway