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CompletedNCT01110096Updated Apr 15, 2020

Family Based Intervention in Childhood obesitY

An interventional study of Parent Management Training - Oregon (PMTO) and Motivational interviewing in Obesity, sponsored by Sykehuset i Vestfold HF. Completed at 2 sites in Norway. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-15.

Sponsored by Sykehuset i Vestfold HF · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Child
  • Parent
  • Family
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Sykehuset i Vestfold HF is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age 7 to 12 years
  • BMI > iso-BMI 30 (Coles index)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Group A - family camp

    Obese families participate in a two week camp with two years follow-up.

    Behavioral: Parent Management Training - Oregon (PMTO) · Behavioral: Motivational interviewing · Behavioral: Dynamic group therapy

  • Other
    Group B - family lifestyle school

    Families participate in a four day practical course about lifestyle.

    Behavioral: Motivational interviewing

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.

06

What researchers measure

Primary outcomes

  1. BMI-SDS

    Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.

    Time frame: After 2 years

Secondary outcomes

  1. Quality of life

    Questionnaire for children and parent

    Time frame: After 2 years

  2. Physical fitness

    Six minutes walk test for children and parents.

    Time frame: After 2 years

  3. Behaviour

    Evaluating effect of intervention on risk for psyciatric disorders.

    Time frame: After 2 years

  4. 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.

    Time frame: After 2 years

07

Study locations

2 sites
  • St Olavs Hospital
    Trondheim, 7006, Norway
  • Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
    Tønsberg, 3103, Norway
08

References and documents

Publications

  • Benestad B, Karlsen TI, Smastuen MC, Lekhal S, Hertel JK, Steinsbekk S, Kolotkin RL, Odegard RA, Hjelmesaeth J. Health-related quality of life after camp-based family obesity treatment: an RCT. BMJ Paediatr Open. 2019 Apr 3;3(1):e000413. doi: 10.1136/bmjpo-2018-000413. eCollection 2019. PubMed 31206074 ↗
  • Benestad B, Lekhal S, Smastuen MC, Hertel JK, Halsteinli V, Odegard RA, Hjelmesaeth J. Camp-based family treatment of childhood obesity: randomised controlled trial. Arch Dis Child. 2017 Apr;102(4):303-310. doi: 10.1136/archdischild-2015-309813. Epub 2016 Nov 2. PubMed 27806969 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01110096
Lead sponsor
Sykehuset i Vestfold HF
Collaborators
St. Olavs Hospital, Røros Rehabiliteringssenter, Oslo University Hospital, Evjeklinikken, Gjensidigestiftelsen, Stiftelsen Helse og Rehabilitering, Organisasjonen Voksne for Barn
Responsible party
Samira Lekhal (MD, PhD, Head Children department Morbid Obesity Center, Sykehuset i Vestfold HF) — Principal investigator
First posted
Apr 26, 2010
Start date
Apr 2010
Primary completion
May 2013
Completion
Mar 2020
Last update
Apr 15, 2020

Study contacts

Samira Lekhal, PhD, MD
principal investigator · The Hospital of Vestfold
Jøran Hjelmesæth, PhD, MD
study chair · The Hospital of Vestfold

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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