NCT01110096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

3.1 years

First QC Date

April 21, 2010

Last Update Submit

April 14, 2020

Conditions

Obesity

Keywords

ObesityChildParentFamily

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Quality of life

    After 2 years

  • Physical fitness

    After 2 years

  • Behaviour

    After 2 years

  • Blood samples

    After 2 years

Study Arms (2)

Group A - family camp

EXPERIMENTAL

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

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

Group B - family lifestyle school

OTHER

Families participate in a four day practical course about lifestyle.

Behavioral: Motivational interviewing

Interventions

Parent Management Training - Oregon (PMTO)BEHAVIORAL

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

Group A - family camp
Motivational interviewingBEHAVIORAL

Communication method to facilitate behavioral change and empower the parents.

Group A - family campGroup B - family lifestyle school
Dynamic group therapyBEHAVIORAL

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

Group A - family camp

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Olavs Hospital

Trondheim, 7006, Norway

Location

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

Tønsberg, 3103, Norway

Location

Related Publications (2)

  • 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.

    PMID: 31206074DERIVED

  • 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.

    PMID: 27806969DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Samira Lekhal, PhD, MD

    The Hospital of Vestfold

    PRINCIPAL INVESTIGATOR

  • Jøran Hjelmesæth, PhD, MD

    The Hospital of Vestfold

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Head Children department Morbid Obesity Center

Study Record Dates

First Submitted

April 21, 2010

First Posted

April 26, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2013

Study Completion

March 1, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

NO(2)