OverweightPhase 2GRIB-2004NCT00554645
GRIB Forsoeget-2004
A Phase 2 study testing multi-disciplinary group intervention and traditional information in people with Overweight, run by Forskningspuljen at 1 site in Denmark.
Trial summary
The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as implied by the standard treatment but from difficulties in following the advice. The hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be more efficient in obtaining weight reduction. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Overweight
- What is being tested?
- multi-disciplinary group intervention and traditional information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Nov 2007
- Phase
- Phase 2
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight compared to hight over 135% of the Danish norms (www.peadiatri.dk)
Who cannot join
- None of the parents wants to participate
- Diagnosed somatic course of overweight
- Parents or children do not speak danish
- Sever physical handicap
- Psychiatric illness or mental retardation in children or parents
- Severe child abuse
- Siblings participation in the trail.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -
The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as implied by the standard treatment but from difficulties in following the advice. The hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be more efficient in obtaining weight reduction. The effect of psychological group treatment of severely overweight children and their parents is compared with traditional nutritional information. In other words: Which is better: back-up or enlightenment?
Read the detailed description
At on-set the children get a medical examination, blood-tests, measurement of height, weight, skin-fold, waist and hip. Children and parents fill out questionnaires on social and educational background as well as motivation and expectations to the treatment. All Children are thereafter randomised into two groups:multi-disciplinary group intervention versus traditional information. The randomisation is stratified according to gender and degree of overweight (135%-145% and >145%) supposing that the degree of overweight may mirror the difficulties in loosing weight. The experimental intervention consists of one lecture of general nutrition, weekly psychological group sessions for the children followed by physical exercise, and separate bi-monthly group sessions for the parents. After six months children and parents go to separate group sessions once a month for six months. The control group is offered nutritional advice once with a brief follow-up after one month. The height and weight of the children is measured every month, and the fat % is measured with DEXA-scanning at on-set, after six months, and after twelve months
- Conditions
- Overweight
- Being tested
- multi-disciplinary group intervention, traditional information
- Keywords
- obesity, children, psychological intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-disciplinary group interventionBehavioural
children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months
traditional informationOther
1 session of nutritional advise for parents and child and 1 follow-up after one month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Multi-disciplinary group intervention Receives: Behavioral: multi-disciplinary group intervention |
| 2 | Active comparator | traditional information Receives: Other: traditional information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: Baseline, 6 months, 12 months
Secondary outcomes (1)
fat% measured by DEXA scan, Hip/waist ratio, skinfold
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startJan 2004
- Study completionNov 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forskningspuljen
- Sponsor type
- Other government
- Collaborators
- Den Sundhedsvidenskabelige Forskningsfond (Region 3), Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste
- Investigators
- Ole Andersen, dr. med., Study chair, former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554645
- Sponsor's protocol ID
- ø-2003-1-40
- Acronym
- GRIB-2004
- Status last verified
- Nov 2007
- First submitted
- 5 Nov 2007
- Last updated
- 7 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -
- ClinicalTrials.gov ID
- NCT00554645
- Acronym / sponsor ID
- GRIB-2004 / ø-2003-1-40
- Conditions
- Overweight
- Keywords
- obesity, children, psychological intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ForskningspuljenOther government
- Collaborators
- Den Sundhedsvidenskabelige Forskningsfond (Region 3), Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste
- Study start
- Jan 2004
- Study completion
- Nov 2007 (actual)
- First posted
- 7 Nov 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.
The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as implied by the standard treatment but from difficulties in following the advice. The hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be more efficient in obtaining weight reduction. The effect of psychological group treatment of severely overweight children and their parents is compared with traditional nutritional information. In other words: Which is better: back-up or enlightenment?
Detailed description
At on-set the children get a medical examination, blood-tests, measurement of height, weight, skin-fold, waist and hip. Children and parents fill out questionnaires on social and educational background as well as motivation and expectations to the treatment. All Children are thereafter randomised into two groups:multi-disciplinary group intervention versus traditional information. The randomisation is stratified according to gender and degree of overweight (135%-145% and >145%) supposing that the degree of overweight may mirror the difficulties in loosing weight. The experimental intervention consists of one lecture of general nutrition, weekly psychological group sessions for the children followed by physical exercise, and separate bi-monthly group sessions for the parents. After six months children and parents go to separate group sessions once a month for six months. The control group is offered nutritional advice once with a brief follow-up after one month. The height and weight of the children is measured every month, and the fat % is measured with DEXA-scanning at on-set, after six months, and after twelve months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: multi-disciplinary group interventionMulti-disciplinary group intervention |
| 2 | Active comparator | Other: traditional informationtraditional information |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Weight compared to hight over 135% of the Danish norms (www.peadiatri.dk)
Key exclusion criteria (7 listed)
- None of the parents wants to participate
- Diagnosed somatic course of overweight
- Parents or children do not speak danish
- Sever physical handicap
- Psychiatric illness or mental retardation in children or parents
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 |
|---|---|---|
| multi-disciplinary group interventionchildren:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months | Behavioural | 1 |
| traditional information1 session of nutritional advise for parents and child and 1 follow-up after one month | Other | 2 |
Primary outcome
Body Mass Index
Time frame: Baseline, 6 months, 12 months
1 secondary outcome
fat% measured by DEXA scan, Hip/waist ratio, skinfold
Time frame: Baseline, 6 months, 12 months
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 7 Nov 2007.
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ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
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Obesity
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.
Ole Andersen, dr. med. study chair
former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing multi-disciplinary group intervention and traditional information in people with Overweight, run by Forskningspuljen at 1 site in Denmark.
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 1 inclusion and 7 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 7 Nov 2007. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Body Mass Index (time frame: Baseline, 6 months, 12 months). 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 7 Nov 2007.