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Family Based Intervention in Childhood obesitY

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01110096
Enrollment
100
Registered
2010-04-26
Start date
2010-04-30
Completion date
2020-03-31
Last updated
2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Child, Parent, Family

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

Interventions

BEHAVIORALParent Management Training - Oregon (PMTO)

Method to help parents and caregivers manage the behavior of the children they are responsible for.

BEHAVIORALMotivational interviewing

Communication method to facilitate behavioral change and empower the parents.

BEHAVIORALDynamic group therapy

Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Røros Rehabiliteringssenter
CollaboratorUNKNOWN
Oslo University Hospital
CollaboratorOTHER
Evjeklinikken
CollaboratorOTHER
Gjensidigestiftelsen
CollaboratorUNKNOWN
Stiftelsen Helse og Rehabilitering
CollaboratorOTHER
Organisasjonen Voksne for Barn
CollaboratorUNKNOWN
Sykehuset i Vestfold HF
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
BMI-SDSAfter 2 yearsPrimary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.

Secondary

MeasureTime frameDescription
Quality of lifeAfter 2 yearsQuestionnaire for children and parent
Physical fitnessAfter 2 yearsSix minutes walk test for children and parents.
BehaviourAfter 2 yearsEvaluating effect of intervention on risk for psyciatric disorders.
Blood samplesAfter 2 yearsImprovement in spesific blood tests with relevance to metabolic syndrome after 2 years intervention? Blood is biobanked at baseline and after 2 years.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026