Family Based Intervention in Childhood obesitY

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Olavs Hospital
Røros Rehabiliteringssenter
Oslo University Hospital
Evjeklinikken
Gjensidigestiftelsen
Stiftelsen Helse og Rehabilitering
Organisasjonen Voksne for Barn
Information provided by (Responsible Party):
Samira Lekhal, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT01110096
First received: April 21, 2010
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Parent Management Training - Oregon (PMTO)
Behavioral: Motivational interviewing
Behavioral: Dynamic group therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.

Resource links provided by NLM:


Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:
  • BMI-SDS [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
    Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
    Questionnaire for children and parent

  • Physical fitness [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
    Six minutes walk test for children and parents.

  • Behaviour [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
    Evaluating effect of intervention on risk for psyciatric disorders.

  • Blood samples [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
    Improvement in spesific blood tests with relevance to metabolic syndrome after 2 years intervention? Blood is biobanked at baseline and after 2 years.


Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: May 2016
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110096

Locations
Norway
St Olavs Hospital
Trondheim, Norway, 7006
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Tønsberg, Norway, 3103
Sponsors and Collaborators
Sykehuset i Vestfold HF
St. Olavs Hospital
Røros Rehabiliteringssenter
Oslo University Hospital
Evjeklinikken
Gjensidigestiftelsen
Stiftelsen Helse og Rehabilitering
Organisasjonen Voksne for Barn
Investigators
Principal Investigator: Samira Lekhal, PhD, MD The Hospital of Vestfold
Study Chair: Jøran Hjelmesæth, PhD, MD The Hospital of Vestfold
  More Information

Additional Information:
No publications provided

Responsible Party: Samira Lekhal, MD, PhD, Head Children department Morbid Obesity Center, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01110096     History of Changes
Other Study ID Numbers: FamilY
Study First Received: April 21, 2010
Last Updated: March 23, 2015
Health Authority: Norway: Ministry of Health and Care Services

Keywords provided by Sykehuset i Vestfold HF:
Obesity
Child
Parent
Family

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 27, 2015