Childhood ObesityNCT03566771
Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment
A study testing CLOSS in people with Childhood Obesity, run by Karolinska Institutet at 10 sites in Sweden.
Trial summary
This study aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. 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
- 82 participants
- Where
- 10 sitesSweden
- Study dates
- 11 Apr 2018to 26 Nov 2019
- 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
- Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25
Who cannot join
- Diagnosed with or undergoing assessment of neuropsychiatric disorder
- Hypothalamic obesity
- Pharmacological treatment that could intervene the obesity treatment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Sweden10 sites
Outpatient pediatric clinic at Hisingen
Gothenburg
Outpatient pediatric clinic in Kungshöjd
Gothenburg
Outpatient pediatric clinic at Hässleholm hospital
Hässleholm
Outpatient pediatric clinic at Helsingborg hospital
Helsingborg
Outpatient pediatric clinic, Hälsan Barnmottagning
Jönköping
Outpatient pediatric clinic at Karlstad hospital
Karlstad
Outpatient pediatric clinic at Nacka hospital
Stockholm
Pediatric clinic, Umeå University Hospital
Umeå
Outpatient pediatric clinic at Västerås central hospital
Västerås
Outpatient pediatric clinic at Ystad hospital
Ystad
About this study
Official title: Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment
This study aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) 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 will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.
- Conditions
- Childhood Obesity
- Being tested
- Usual care, CLOSS
- 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.
Usual careBehavioural
The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment
CLOSSBehavioural
Usual care plus using mobile applications to register weight and physical activity as well as for communication with the clinic. A web-based support system enables health care professionals to follow the patient's daily objectively measured weight and physical activity online.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care according to regular treatment routines at the clinic during 12 months Receives: Behavioral: Usual care |
| CLOSS | Active comparator | Usual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months Receives: Behavioral: CLOSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in degree of obesity
Measured by BMI standard deviation score control vs intervention
Measured: 6 and 12 months after baseline
Secondary outcomes (6)
Number of physical visits
Control vs intervention
Measured: During the intervention 12 months
Cancelation of physical visits
Control vs intervention
Measured: During the intervention 12 months
Time consumption for the health care professionals
Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention
Measured: During the intervention 12 months
Parental experience of treatment
Measured by web-based CLOSS specific questions. Control vs intervention
Measured: During the intervention 3, 6 and 12 months
Health care professional's experiences using the web-based support system
CLOSS specific questions regarding the application
Measured: During the intervention 3, 6 and 12 months
Physical activity level
Measured by time and intensity through the activity measuring wrist-band. Only intervention
Measured: During the intervention 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start11 Apr 2018
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
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 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
- 82 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
- NCT03566771
- Sponsor's protocol ID
- CLOSS200
- Status last verified
- Apr 2020
- First submitted
- 7 Jun 2018
- Last updated
- 8 Apr 2020
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment
- ClinicalTrials.gov ID
- NCT03566771
- Acronym / sponsor ID
- CLOSS200
- Conditions
- Childhood Obesity
- Keywords
- Mobile Health, Self-Monitoring, Behavioural Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 25 Jun 2018 (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 aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) are compared between usual care (control) and usual care with complementary web-based support system (intervention).
Detailed description
In this study children with obesity will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.
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 12 months |
| CLOSS | Active comparator | Behavioral: CLOSSUsual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months |
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
- Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25
Key exclusion criteria (3 listed)
- Diagnosed with or undergoing assessment of neuropsychiatric disorder
- Hypothalamic obesity
- Pharmacological treatment that could intervene the obesity treatment
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 careThe child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment | Behavioural | Usual care |
| CLOSSUsual care plus using mobile applications to register weight and physical activity as well as for communication with the clinic. A web-based support system enables health care professionals to follow the patient's daily objectively measured weight and physical activity online. | Behavioural | CLOSS |
Primary outcome
Changes in degree of obesity
Time frame: 6 and 12 months after baseline
Measured by BMI standard deviation score control vs intervention
6 secondary outcomes
Number of physical visits
Time frame: During the intervention 12 months
Cancelation of physical visits
Time frame: During the intervention 12 months
Time consumption for the health care professionals
Time frame: During the intervention 12 months
Parental experience of treatment
Time frame: During the intervention 3, 6 and 12 months
Health care professional's experiences using the web-based support system
Time frame: During the intervention 3, 6 and 12 months
Physical activity level
Time frame: During the intervention 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 8 Apr 2020.
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, 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.
Pernilla Danielsson, PhD principal investigator
Karolinska Institutet
10 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 10 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 10 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?
Changes in degree of obesity (time frame: 6 and 12 months after baseline). 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 8 Apr 2020.