Family Based Intervention in Childhood obesitY

NCT ID: NCT01110096

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2020-03-31

Brief Summary

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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

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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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A - family camp

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

Group Type EXPERIMENTAL

Parent Management Training - Oregon (PMTO)

Intervention Type BEHAVIORAL

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

Motivational interviewing

Intervention Type BEHAVIORAL

Communication method to facilitate behavioral change and empower the parents.

Dynamic group therapy

Intervention Type BEHAVIORAL

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

Group B - family lifestyle school

Families participate in a four day practical course about lifestyle.

Group Type OTHER

Motivational interviewing

Intervention Type BEHAVIORAL

Communication method to facilitate behavioral change and empower the parents.

Interventions

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Parent Management Training - Oregon (PMTO)

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

Intervention Type BEHAVIORAL

Motivational interviewing

Communication method to facilitate behavioral change and empower the parents.

Intervention Type BEHAVIORAL

Dynamic group therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Røros Rehabiliteringssenter

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Evjeklinikken

OTHER

Sponsor Role collaborator

Gjensidigestiftelsen

UNKNOWN

Sponsor Role collaborator

Stiftelsen Helse og Rehabilitering

OTHER

Sponsor Role collaborator

Organisasjonen Voksne for Barn

UNKNOWN

Sponsor Role collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role lead

Responsible Party

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Samira Lekhal

MD, PhD, Head Children department Morbid Obesity Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samira Lekhal, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital of Vestfold

Jøran Hjelmesæth, PhD, MD

Role: STUDY_CHAIR

The Hospital of Vestfold

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority

Tønsberg, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 31206074 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27806969 (View on PubMed)

Other Identifiers

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FamilY

Identifier Type: -

Identifier Source: org_study_id

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