ObesityNCT01110096
Family Based Intervention in Childhood obesitY
A study testing Parent Management Training - Oregon (PMTO), Motivational interviewing and Dynamic group therapy in people with Obesity, run by Sykehuset i Vestfold HF at 2 sites in Norway.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Parent Management Training - Oregon (PMTO), Motivational interviewing and Dynamic group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2010to Mar 2020
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 7 to 12 years
- BMI > iso-BMI 30 (Coles index)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Tønsberg, 3103
St Olavs Hospital
Trondheim, 7006
About this study
Official title: Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.
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
- Conditions
- Obesity
- Being tested
- Parent Management Training - Oregon (PMTO), Motivational interviewing, Dynamic group therapy
- Keywords
- Obesity, Child, Parent, Family
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Management Training - Oregon (PMTO)Behavioural
Method to help parents and caregivers manage the behavior of the children they are responsible for.
Motivational interviewingBehavioural
Communication method to facilitate behavioral change and empower the parents.
Dynamic group therapyBehavioural
Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.
| Study group | Role | What they receive |
|---|---|---|
| Group A - family camp | Experimental | Obese families participate in a two week camp with two years follow-up. Receives: Behavioral: Parent Management Training - Oregon (PMTO); Behavioral: Motivational interviewing; Behavioral: Dynamic group therapy |
| Group B - family lifestyle school | Other | Families participate in a four day practical course about lifestyle. Receives: Behavioral: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI-SDS
Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.
Measured: After 2 years
Secondary outcomes (4)
Quality of life
Questionnaire for children and parent
Measured: After 2 years
Physical fitness
Six minutes walk test for children and parents.
Measured: After 2 years
Behaviour
Evaluating effect of intervention on risk for psyciatric disorders.
Measured: After 2 years
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.
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2013
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Røros Rehabiliteringssenter, Oslo University Hospital, Evjeklinikken, Gjensidigestiftelsen, Stiftelsen Helse og Rehabilitering, Organisasjonen Voksne for Barn
- Responsible party
- Principal investigator, Samira Lekhal, Sykehuset i Vestfold HF
- Investigators
- Samira Lekhal, PhD, MD, Principal investigator, The Hospital of VestfoldJøran Hjelmesæth, PhD, MD, Study chair, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110096
- Sponsor's protocol ID
- FamilY
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2010
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
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 31206074Benestad 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.
- ClinicalTrials.gov ID
- NCT01110096
- Acronym / sponsor ID
- FamilY
- Conditions
- Obesity
- Keywords
- Obesity, Child, Parent, Family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Røros Rehabiliteringssenter, Oslo University Hospital, Evjeklinikken, Gjensidigestiftelsen, Stiftelsen Helse og Rehabilitering, Organisasjonen Voksne for Barn
- Study start
- Apr 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 26 Apr 2010 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - family camp | Experimental | Behavioral: Parent Management Training - Oregon (PMTO), Behavioral: Motivational interviewing, Behavioral: Dynamic group therapyObese families participate in a two week camp with two years follow-up. |
| Group B - family lifestyle school | Other | Behavioral: Motivational interviewingFamilies participate in a four day practical course about lifestyle. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 7 to 12 years
- BMI > iso-BMI 30 (Coles index)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Parent Management Training - Oregon (PMTO)Method to help parents and caregivers manage the behavior of the children they are responsible for. | Behavioural | Group A - family camp |
| Motivational interviewingCommunication method to facilitate behavioral change and empower the parents. | Behavioural | Group A - family camp, Group B - family lifestyle school |
| Dynamic group therapyFocuses on individual experiences within families and/or parents/children, and that the participants are their own experts. | Behavioural | Group A - family camp |
Primary outcome
BMI-SDS
Time frame: After 2 years
Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.
4 secondary outcomes
Quality of life
Time frame: After 2 years
Physical fitness
Time frame: After 2 years
Behaviour
Time frame: After 2 years
Blood samples
Time frame: After 2 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 15 Apr 2020.
- Derived from this study: PubMed 31206074Benestad 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.
- Derived from this study: PubMed 27806969Benestad 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.
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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.
Samira Lekhal, PhD, MD principal investigator
The Hospital of Vestfold
Jøran Hjelmesæth, PhD, MD study chair
The Hospital of Vestfold
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Management Training - Oregon (PMTO), Motivational interviewing and Dynamic group therapy in people with Obesity, run by Sykehuset i Vestfold HF at 2 sites 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 5 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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
BMI-SDS (time frame: After 2 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 NCT01110096, which also lists 2 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 15 Apr 2020.