ObesityNCT00872807
The Activity School in Finnmark for Overweight Children
A study testing Lifestyle counseling in groups and Individual intervention in people with Obesity and Overweight, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Lifestyle counseling in groups and Individual intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Overweight or obese.
- BMI > IOTF (International Obesity TaskForce) cut-points 27,5. kg/ m2.
Who cannot join
- Diseases not compatible with normal physical activity.
- Disorders not compatible with group treatment.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Childrens departement Finnmark Hospital, Norway
Hammerfest, Hammerfest, 9600
About this study
Official title: The Activity School in Finnmark for Overweight and Obese Children and Their Families
The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community. The two interventions are both hospital and community based.
Read the detailed description
Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.
- Conditions
- Obesity, Overweight
- Being tested
- Lifestyle counseling in groups, Individual intervention
- Keywords
- childhood, therapy, life style, motor activity, obesity, overweight, body mass index, treatment
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counseling in groupsBehavioural
The activity school in Finnmark. Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality.
They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.
Individual interventionBehavioural
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
| Study group | Role | What they receive |
|---|---|---|
| Group intervention | Experimental | Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality. They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months. Receives: Behavioral: Lifestyle counseling in groups; Behavioral: Individual intervention |
| Individual intervention | Active comparator | Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model. Receives: Behavioral: Individual intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index compared to baseline
BMI will be measured at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counselling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Secondary outcomes (10)
Change in Systolic Blood Pressure compared to baseline
Measured with an automated blood pressure monitor at baseline, at 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at the end (2 years) of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Change in Body fat compared to baseline
Measured with bioelectrical impedance analysis at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up.Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Change in activity level / Counts per min compared to baseline
Measured with accelerometers at baseline, 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Change in Waist circumference compared to baseline
Measured with measuring tape mid-point between the lowest rib and the top of the iliac crest at baseline, 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment stopped, 3 years from baseline.
Measured: 3 years
Change in Homa Score / HOMA IR compared to baseline
Homa score calculated from the cross product of fasting plasma insulin and plasma glucose divided with a factor of 22.5. Fasting plasma insulin and glucose will be measured at baseline, at 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification.Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Change in triceps skinfold compared to baseline
Measured with Holtain Tanner /Whitehouse Skinfold Caliper at baseline,3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification.Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Change in self-concept compared to baseline
Measured with SPPC, Self Perception Profile for Children at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up. Primary outcome measured at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped.
Measured: 3 years
Change in psychiatric health compared to baseline
Measured with Strengths and difficulties Questionnaire ( SDQ-S)at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up. Primary measurement at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped.
Measured: 3 years
Change in fitness from baseline
Measured with Andersen's test (shuttle test) at baseline, 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Change in quality of life compared to baseline
Measured with KINDL (Kinder Lebensqualitet Fragebogen) at baseline, 6 months-, 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Finnmark Hospital Trust, The Royal Norwegian Ministry of Health, Norwegian Foundation for Health and Rehabilitation, Norwegian Directorate of Health
- Responsible party
- Sponsor
- Investigators
- Trond Flægstad, Professor, Study chair, UNorth Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872807
- Sponsor's protocol ID
- 2007/5.2006.3473 (REK)
- Other IDs
- 15873 (NSD)
- Status last verified
- Dec 2012
- First submitted
- 30 Mar 2009
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kokkvoll A, Grimsgaard S, Odegaard R, Flaegstad T, Njolstad I. Single versus multiple-family intervention in childhood overweight--Finnmark Activity School: a randomised trial. Arch Dis Child. 2014 Mar;99(3):225-31. doi: 10.1136/archdischild-2012-303571. Epub 2013 Dec 11.
PubMed 24336385Kokkvoll A, Grimsgaard S, Steinsbekk S, Flaegstad T, Njolstad I. Health in overweight children: 2-year follow-up of Finnmark Activity School--a randomised trial. Arch Dis Child. 2015 May;100(5):441-8. doi: 10.1136/archdischild-2014-307107. Epub 2014 Nov 20.
PubMed 25414250Kokkvoll AS, Grimsgaard S, Flaegstad T, Andersen LB, Ball GDC, Wilsgaard T, Njolstad I. No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. Acta Paediatr. 2020 Jan;109(1):183-192. doi: 10.1111/apa.14916. Epub 2019 Jul 30.
PubMed 31240752
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Activity School in Finnmark for Overweight and Obese Children and Their Families
- ClinicalTrials.gov ID
- NCT00872807
- Acronym / sponsor ID
- 2007/5.2006.3473 (REK)
- Conditions
- Obesity, Overweight
- Keywords
- childhood, therapy, life style, motor activity, obesity, overweight, body mass index, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Finnmark Hospital Trust, The Royal Norwegian Ministry of Health, Norwegian Foundation for Health and Rehabilitation, Norwegian Directorate of Health
- Study start
- Apr 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community. The two interventions are both hospital and community based.
Detailed description
Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group intervention | Experimental | Behavioral: Lifestyle counseling in groups, Behavioral: Individual interventionLifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality. They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months. |
| Individual intervention | Active comparator | Behavioral: Individual interventionLifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Overweight or obese.
- BMI > IOTF (International Obesity TaskForce) cut-points 27,5. kg/ m2.
Key exclusion criteria (2 listed)
- Diseases not compatible with normal physical activity.
- Disorders not compatible with group treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counseling in groupsThe activity school in Finnmark. Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality. They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months. | Behavioural | Group intervention |
| Individual interventionConventional lifestyle counseling individually by single health professionals, both in hospital and in municipality. | Behavioural | Group intervention, Individual intervention |
Primary outcome
Change in Body Mass Index compared to baseline
Time frame: 3 years
BMI will be measured at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counselling and active treatment has stopped, 3 years from baseline.
10 secondary outcomes
Change in Systolic Blood Pressure compared to baseline
Time frame: 3 years
Change in Body fat compared to baseline
Time frame: 3 years
Change in activity level / Counts per min compared to baseline
Time frame: 3 years
Change in Waist circumference compared to baseline
Time frame: 3 years
Change in Homa Score / HOMA IR compared to baseline
Time frame: 3 years
Change in triceps skinfold compared to baseline
Time frame: 3 years
Change in self-concept compared to baseline
Time frame: 3 years
Change in psychiatric health compared to baseline
Time frame: 3 years
Change in fitness from baseline
Time frame: 3 years
Change in quality of life compared to baseline
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Results publication: PubMed 24336385Kokkvoll A, Grimsgaard S, Odegaard R, Flaegstad T, Njolstad I. Single versus multiple-family intervention in childhood overweight--Finnmark Activity School: a randomised trial. Arch Dis Child. 2014 Mar;99(3):225-31. doi: 10.1136/archdischild-2012-303571. Epub 2013 Dec 11.
- Results publication: PubMed 25414250Kokkvoll A, Grimsgaard S, Steinsbekk S, Flaegstad T, Njolstad I. Health in overweight children: 2-year follow-up of Finnmark Activity School--a randomised trial. Arch Dis Child. 2015 May;100(5):441-8. doi: 10.1136/archdischild-2014-307107. Epub 2014 Nov 20.
- Derived from this study: PubMed 31240752Kokkvoll AS, Grimsgaard S, Flaegstad T, Andersen LB, Ball GDC, Wilsgaard T, Njolstad I. No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. Acta Paediatr. 2020 Jan;109(1):183-192. doi: 10.1111/apa.14916. Epub 2019 Jul 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trond Flægstad, Professor study chair
UNorth Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in groups and Individual intervention in people with Obesity and Overweight, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index compared to baseline (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00872807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.