Childhood ObesityNCT03380598
An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment
A study testing CLOSS in people with Childhood Obesity, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. 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?
- CLOSS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesSweden
- Study dates
- 20 Sep 2017to 24 Sep 2018
- 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)
- Swedish speaking parents
- Parents able to use a smart phone
- No pharmacological treatment that could intervene the obesity treatment
Who cannot join
- Diagnosed with or undergoing assessment of neuropsychiatric disorder
- Structured obesity treatment the past 6 months
- Hypothalamic obesity
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
National Childhood Obesity Center, Karolinska University hospital
Huddinge
Outpatient paediatric clinic at Norrtälje Hospital
Norrtälje
Outpatient paediatric clinic at Södertälje Hospital
Södertälje
About this study
Official title: An Evaluation of a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Trial of Childhood Obesity Treatment
This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. Changes in BMI standard deviation score are compared between usual care (control) and usual care with complementary web-based support system (intervention).
Read the detailed description
In this study children with obesity were randomized to either usual care according to regular routine (control group) or to usual care plus a web-based support system (intervention group). The system is based on a smartphone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smartphone, where data is presented graphically. The data is transferred to the clinic for support. The system is developed for communication between the clinic and family. The randomization was done at the start of individual treatment and lasted for 6 months. Investigators studied the families and health care professional's experience of using the web-based support system as well as changes in BMI standard deviation score in the control and intervention group.
- Conditions
- Childhood Obesity
- Being tested
- CLOSS, Usual care
- Keywords
- Mobile Health, Self-Monitoring, Behavioural Treatment
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLOSSBehavioural
Usual care plus using mobile application's to register weight and physical activity as well as for communication with the clinic. A web-based system enables health care professionals to follow the the patient's daily weight registration online.
Usual careBehavioural
Usual care. The child and parent(s) at regular visits to the nurse at the clinic
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care according to regular treatment routines at the clinic during 6 months. Receives: Behavioral: Usual care |
| CLOSS | Active comparator | Usual care plus using a web based support system for self-monitoring weight at physical activity. Receives: Behavioral: CLOSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Familie's experience and feasibility of the treatment
CLOSS specific questionnaire, control vs intervention
Measured: 6 months after baseline
Secondary outcomes (2)
Health care professional's required working time for control vs intervention
Time report
Measured: During the intervention 6 months
Health care professional's experience using the web based support system
CLOSS specific questions regarding the application
Measured: During the intervention 3 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 posted21 Dec 2017
- Study start20 Sep 2017
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernilla Danielsson, Karolinska Institutet
- Investigators
- Pernilla Danielsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380598
- Sponsor's protocol ID
- CLOSS100
- Status last verified
- Apr 2020
- First submitted
- 8 Nov 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johansson L, Hagman E, Danielsson P. A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. BMC Pediatr. 2020 Sep 23;20(1):447. doi: 10.1186/s12887-020-02338-9.
PubMed 32967638
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Trial of Childhood Obesity Treatment
- ClinicalTrials.gov ID
- NCT03380598
- Acronym / sponsor ID
- CLOSS100
- Conditions
- Childhood Obesity
- Keywords
- Mobile Health, Self-Monitoring, Behavioural Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 21 Dec 2017 (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.
This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. Changes in BMI standard deviation score are compared between usual care (control) and usual care with complementary web-based support system (intervention).
Detailed description
In this study children with obesity were randomized to either usual care according to regular routine (control group) or to usual care plus a web-based support system (intervention group). The system is based on a smartphone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smartphone, where data is presented graphically. The data is transferred to the clinic for support. The system is developed for communication between the clinic and family. The randomization was done at the start of individual treatment and lasted for 6 months. Investigators studied the families and health care professional's experience of using the web-based support system as well as changes in BMI standard deviation score in the control and intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual careUsual care according to regular treatment routines at the clinic during 6 months. |
| CLOSS | Active comparator | Behavioral: CLOSSUsual care plus using a web based support system for self-monitoring weight at physical activity. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Obesity according to International Obesity Task Force (IOTF)
- Swedish speaking parents
- Parents able to use a smart phone
- No pharmacological treatment that could intervene the obesity treatment
Key exclusion criteria (3 listed)
- Diagnosed with or undergoing assessment of neuropsychiatric disorder
- Structured obesity treatment the past 6 months
- Hypothalamic obesity
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 |
|---|---|---|
| CLOSSUsual care plus using mobile application's to register weight and physical activity as well as for communication with the clinic. A web-based system enables health care professionals to follow the the patient's daily weight registration online. | Behavioural | CLOSS |
| Usual careUsual care. The child and parent(s) at regular visits to the nurse at the clinic | Behavioural | Usual care |
Primary outcome
Familie's experience and feasibility of the treatment
Time frame: 6 months after baseline
CLOSS specific questionnaire, control vs intervention
2 secondary outcomes
Health care professional's required working time for control vs intervention
Time frame: During the intervention 6 months
Health care professional's experience using the web based support system
Time frame: During the intervention 3 and 6 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 8 Apr 2020.
- Derived from this study: PubMed 32967638Johansson L, Hagman E, Danielsson P. A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. BMC Pediatr. 2020 Sep 23;20(1):447. doi: 10.1186/s12887-020-02338-9.
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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.
Pernilla Danielsson, PhD principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLOSS in people with Childhood Obesity, run by Karolinska Institutet 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 4 inclusion and 3 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 8 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 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?
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?
Familie's experience and feasibility of the treatment (time frame: 6 months after baseline). 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 NCT03380598, which also lists 1 linked publication.
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 8 Apr 2020.