OverweightNCT00458224
Prevention of Permanent Obesity in Children
A study testing parental counseling in people with Overweight and Obesity, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
In the county of Oppland, Norway, questionnaires addressing physical and mental health and socioeconomic status is issued to all (1960) families who meet for the pre-school assessment at the public health clinics in 2007. Particularly growth, physical activity and diet is addressed. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Overweight, Obesity, Child
- What is being tested?
- parental counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2007to Apr 2015
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI > 18.9
- Age 5-7 years
- Residing in Oppland county
Who cannot join
- chronic disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
Sykehuset innlandet HF, Department of Pediatrics
Lillehammer, N-2629
About this study
In the county of Oppland, Norway, questionnaires addressing physical and mental health and socioeconomic status is issued to all (1960) families who meet for the pre-school assessment at the public health clinics in 2007. Particularly growth, physical activity and diet is addressed.
Families who have children with a BMI >18.9, which corresponds to BMI>30, and living in selected municipalities in the county are invited to participate in a 5 year intervention program in order to avoid future overweight conditions in children. Similarly overweight children from the rest of the county serve as controls.
Read the detailed description
Background: Intervention programs to limit or reduce weight in severely obese adults and adolescents are rarely successful. In the present study intervention is aimed at moderately overweight children of 6 years.
Families in 7 municipalities who have children with BMI >18.9 are invited to a group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training. The families are invited to meet in groups times the first year, two times the second and one time the third year. According to personal interest the families are also invited to meet with the nurse between each of the the above gatherings.
The children are examined by a pediatrician before entry and after 1, 2, 3 and 5 years with specific focus on height and weight. No blood studies are routinely done.
BMI development will be related to BMIs in the family, mother's weight increase in pregnancy, socioeconomic background, general health, psychological factors scored through the Strengths And Difficulties Questionnaire, and compliance with the program. Furthermore, the results are compared to similarly overweight children from the counties who are not invited to participate in the intervention program. The results are obtained through the routine health follow-up programs in school.
- Conditions
- Overweight, Obesity, Child
- Being tested
- parental counseling
- Keywords
- overweight, obesity, child
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parental counselingBehavioural
Also called Life style counseling
Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training
| Study group | Role | What they receive |
|---|---|---|
| Parental counseling | Experimental | Life style counseling Receives: Behavioral: parental counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of BMI from a specific family oriented program
Measured: 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Principal investigator, Trond Markestad, Sykehuset Innlandet HF
- Investigators
- Trond Markestad, Md. PhD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458224
- Sponsor's protocol ID
- 150089
- Status last verified
- Jun 2015
- First submitted
- 7 Apr 2007
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Permanent Obesity in Children
- ClinicalTrials.gov ID
- NCT00458224
- Acronym / sponsor ID
- 150089
- Conditions
- Overweight, Obesity, Child
- Keywords
- overweight, obesity, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Feb 2007
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Apr 2007 (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.
In the county of Oppland, Norway, questionnaires addressing physical and mental health and socioeconomic status is issued to all (1960) families who meet for the pre-school assessment at the public health clinics in 2007. Particularly growth, physical activity and diet is addressed.
Families who have children with a BMI >18.9, which corresponds to BMI>30, and living in selected municipalities in the county are invited to participate in a 5 year intervention program in order to avoid future overweight conditions in children. Similarly overweight children from the rest of the county serve as controls.
Detailed description
Background: Intervention programs to limit or reduce weight in severely obese adults and adolescents are rarely successful. In the present study intervention is aimed at moderately overweight children of 6 years.
Families in 7 municipalities who have children with BMI >18.9 are invited to a group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training. The families are invited to meet in groups times the first year, two times the second and one time the third year. According to personal interest the families are also invited to meet with the nurse between each of the the above gatherings.
The children are examined by a pediatrician before entry and after 1, 2, 3 and 5 years with specific focus on height and weight. No blood studies are routinely done.
BMI development will be related to BMIs in the family, mother's weight increase in pregnancy, socioeconomic background, general health, psychological factors scored through the Strengths And Difficulties Questionnaire, and compliance with the program. Furthermore, the results are compared to similarly overweight children from the counties who are not invited to participate in the intervention program. The results are obtained through the routine health follow-up programs in school.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parental counseling | Experimental | Behavioral: parental counselingLife style counseling |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI > 18.9
- Age 5-7 years
- Residing in Oppland county
Key exclusion criteria (1 listed)
- chronic disease
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 |
|---|---|---|
| parental counselingAlso: Life style counselingGroup-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training | Behavioural | Parental counseling |
Primary outcome
Effect of BMI from a specific family oriented program
Time frame: 1, 3 and 5 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 3 Jun 2015.
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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 Markestad, Md. PhD principal investigator
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parental counseling in people with Overweight and Obesity, run by Sykehuset Innlandet HF 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 3 inclusion and 1 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 3 Jun 2015. 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?
Effect of BMI from a specific family oriented program (time frame: 1, 3 and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2015.