Family Based Intervention in Childhood obesitY
|ClinicalTrials.gov Identifier: NCT01110096|
Recruitment Status : Active, not recruiting
First Posted : April 26, 2010
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment|
|Obesity||Behavioral: Parent Management Training - Oregon (PMTO) Behavioral: Motivational interviewing Behavioral: Dynamic group therapy|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.|
|Study Start Date :||April 2010|
|Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||June 2018|
Experimental: Group A - family camp
Obese families participate in a two week camp with two years follow-up.
Behavioral: Parent Management Training - Oregon (PMTO)
Method to help parents and caregivers manage the behavior of the children they are responsible for.Behavioral: Motivational interviewing
Communication method to facilitate behavioral change and empower the parents.Behavioral: Dynamic group therapy
Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.
Experimental: Group B - family lifestyle school
Families participate in a four day practical course about lifestyle.
Behavioral: Motivational interviewing
Communication method to facilitate behavioral change and empower the parents.
- BMI-SDS [ Time Frame: After 2 years ]Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.
- Quality of life [ Time Frame: After 2 years ]Questionnaire for children and parent
- Physical fitness [ Time Frame: After 2 years ]Six minutes walk test for children and parents.
- Behaviour [ Time Frame: After 2 years ]Evaluating effect of intervention on risk for psyciatric disorders.
- Blood samples [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110096
|St Olavs Hospital|
|Trondheim, Norway, 7006|
|Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority|
|Tønsberg, Norway, 3103|
|Principal Investigator:||Samira Lekhal, PhD, MD||The Hospital of Vestfold|
|Study Chair:||Jøran Hjelmesæth, PhD, MD||The Hospital of Vestfold|