Family Based Intervention in Childhood obesitY

Obesity Clinical Trial

Official title:

Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110096
• Other study ID #: FamilY
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: March 2020

Study information

• Verified date: April 2020
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Norway	Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority	Tønsberg
Norway	St Olavs Hospital	Trondheim

Sponsors (8)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	Evjeklinikken, Gjensidigestiftelsen, Organisasjonen Voksne for Barn, Oslo University Hospital, Røros Rehabiliteringssenter, St. Olavs Hospital, Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI-SDS	Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.	After 2 years
Secondary	Quality of life	Questionnaire for children and parent	After 2 years
Secondary	Physical fitness	Six minutes walk test for children and parents.	After 2 years
Secondary	Behaviour	Evaluating effect of intervention on risk for psyciatric disorders.	After 2 years
Secondary	Blood samples	Improvement in spesific blood tests with relevance to metabolic syndrome after 2 years intervention? Blood is biobanked at baseline and after 2 years.	After 2 years

External Links

•   Information about FamilY