Childhood ObesityWebcopNCT04013230
Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families
A study testing Web-COP in people with Childhood Obesity, run by Umeå University at 3 sites in Sweden.
Trial summary
The aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Web-COP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSweden
- Study dates
- 21 Aug 2019to 30 Dec 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Obesity according to International Obesity Task Force (IOTF)
- Be able to speak and write Swedish
- Have internet access in parents' home
Who cannot join
- Obesity together with other severe disease including neuropsychiatric disorder
Trial locations and contacts
3 sites in 1 country.
Annika Janson, PhD contact
Sweden3 sites, 3 recruiting
- Recruiting
Outpatient peadictric clinic in Sollefteå hospital
Sollefteå, 88100
Annelie Thorén, PhD, annelie.thoren@rvn.se
- Recruiting
Outpatient peadiatric clinic in Sundsvalls hospital
Sundsvall, 856 43
Annelie Thorén, PhD
- Recruiting
Umeå university
Umeå, 901 87
Sven-Arne Silfverdal, MD, +46 70 764 05 87, sven-arne.silfverdal@umu.se
About this study
Official title: Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families - a Randomized Controlled Trial of Children With Obesity in Northern Sweden
The aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents.
The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program and will be offered to children aged 5-12 years with obesity (International Obesity Task Force-BMI >30), and their parents.
Read the detailed description
Obesity in children and adolescents worldwide has increased from 1 % in 1975 to about 6 % in 2016. Experts have estimated that the world will have more obese children and adolescents than underweight at the year 2022. Preventing and reversing excess weight gain in children is important since obesity often tracks into adulthood with adverse health consequences.
Web-based interventions have been shown to be effective, to have a beneficial treatment outcome and have been proposed to have great potential to reach many children and improve cost effectiveness.
This is a randomized controlled study with cross-over design. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program. The control group will have standard care treatment consisting of doctor's appointment and, in some cases, contact with dietician.
- Conditions
- Childhood Obesity
- Being tested
- Usual care, Web-COP
- Keywords
- Childhood obesity, BMI SDS
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Visit doctor and nurse at the clinic.
Web-COPBehavioural
Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care according to regular treatment routines at the clinic. Receives: Behavioral: Usual care; Behavioral: Web-COP |
| Web-COP | Active comparator | Usual care plus group sessions and a web-based treatment program Receives: Behavioral: Usual care; Behavioral: Web-COP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI-SDS
Controll vs intervention
Measured: At baseline, 2, 4 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start21 Aug 2019 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Västernorrland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Sven-Arne Silfverdal, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013230
- Sponsor's protocol ID
- 2019-02343
- Other IDs
- 2019
- Acronym
- Webcop
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families - a Randomized Controlled Trial of Children With Obesity in Northern Sweden
- ClinicalTrials.gov ID
- NCT04013230
- Acronym / sponsor ID
- Webcop / 2019-02343
- Conditions
- Childhood Obesity
- Keywords
- Childhood obesity, BMI SDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Västernorrland County Council, Sweden
- Study start
- 21 Aug 2019 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 9 Jul 2019 (actual)
- 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 aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents.
The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program and will be offered to children aged 5-12 years with obesity (International Obesity Task Force-BMI >30), and their parents.
Detailed description
Obesity in children and adolescents worldwide has increased from 1 % in 1975 to about 6 % in 2016. Experts have estimated that the world will have more obese children and adolescents than underweight at the year 2022. Preventing and reversing excess weight gain in children is important since obesity often tracks into adulthood with adverse health consequences.
Web-based interventions have been shown to be effective, to have a beneficial treatment outcome and have been proposed to have great potential to reach many children and improve cost effectiveness.
This is a randomized controlled study with cross-over design. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program. The control group will have standard care treatment consisting of doctor's appointment and, in some cases, contact with dietician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual care, Behavioral: Web-COPUsual care according to regular treatment routines at the clinic. |
| Web-COP | Active comparator | Behavioral: Usual care, Behavioral: Web-COPUsual care plus group sessions and a web-based treatment program |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Obesity according to International Obesity Task Force (IOTF)
- Be able to speak and write Swedish
- Have internet access in parents' home
Key exclusion criteria (1 listed)
- Obesity together with other severe disease including neuropsychiatric disorder
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 |
|---|---|---|
| Usual careVisit doctor and nurse at the clinic. | Behavioural | Usual care, Web-COP |
| Web-COPUsual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents. | Behavioural | Usual care, Web-COP |
Primary outcome
Change in BMI-SDS
Time frame: At baseline, 2, 4 and 6 months
Controll vs intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
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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.
Annika Janson, PhD contact
Sven-Arne Silfverdal, PhD principal investigator
Umeå University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-COP in people with Childhood Obesity, run by Umeå University at 3 sites in Sweden.
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: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annelie Thorén, MD (+46 73 678 65 93, annelie.thoren@rvn.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI-SDS (time frame: At baseline, 2, 4 and 6 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 12 Jul 2019.