Childhood ObesityNCT04323215
Evaluation of a Digital Childhood Obesity Treatment
An observational study of Childhood Obesity and Treatment Adherence, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Childhood Obesity, Treatment Adherence
- What is being tested?
- Support system
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2018to 1 May 2020
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. Approximately 120 children 3-18 years will be included in this first evaluation.
Who may be able to join
- Obesity according to International Obesity Task Force (IOTF)
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment
This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.
Read the detailed description
Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.
In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.
The evaluation will be carried out when approximately 120 children have had the opportunity to be treated with the support system for one year. The results will be compared with a matched control group from the BORIS childhood obesity treatment register.
- Conditions
- Childhood Obesity, Treatment Adherence
- Being tested
- Support system
- Keywords
- Mobile Health, Support System, Behavioral treatment, Self-Monitoring
- Medical subject headings
- Pediatric Obesity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support systemDevice
A support system named Provement will be used to provide behavioral treatment.
| Study group | Role | What they receive |
|---|---|---|
| Support system users | Usual care (behavioral treatment) plus the support system for self-monitoring of weight and communication with the clinic during one year of treatment. Receives: Device: Support system | |
| Control group | Children treated with usual care according to regular treatment routines registred in BORIS the Swedish childhood obesity treatment register |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in degree of obesity
Measured by BMI standard deviation score. Support system users vs control
Measured: From start of treatment to one year follow-up
Secondary outcomes (5)
The use of the support system - weighings
Number of weighings/week
Measured: From start of treatment to one year follow-up
The use of the support system - text messages
Number text messages/week
Measured: From start of treatment to one year follow-up
Number of physical visits
Visits to the clinic. Support system users vs control
Measured: From start of treatment to one year follow-up
Number of cancelation of physical visits
Visits to the clinic. Support system users vs control
Measured: From start of treatment to one year follow-up
Number of patients not showing up to physical visit
Visits to the clinic. Support system users vs control
Measured: From start of treatment to one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Sep 2018
- Primary completion31 Mar 2020
- Study completion1 May 2020
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 156 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, CLINTEC, Division of pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323215
- Sponsor's protocol ID
- Provement100
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.
PubMed 35641569
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment
- ClinicalTrials.gov ID
- NCT04323215
- Acronym / sponsor ID
- Provement100
- Conditions
- Childhood Obesity, Treatment Adherence
- Keywords
- Mobile Health, Support System, Behavioral treatment, Self-Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 26 Mar 2020 (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 digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.
Detailed description
Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.
In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.
The evaluation will be carried out when approximately 120 children have had the opportunity to be treated with the support system for one year. The results will be compared with a matched control group from the BORIS childhood obesity treatment register.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Support system users | – | Device: Support systemUsual care (behavioral treatment) plus the support system for self-monitoring of weight and communication with the clinic during one year of treatment. |
| Control group | – | –Children treated with usual care according to regular treatment routines registred in BORIS the Swedish childhood obesity treatment register |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. Approximately 120 children 3-18 years will be included in this first evaluation.
Key inclusion criteria (1 listed)
- Obesity according to International Obesity Task Force (IOTF)
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Support systemA support system named Provement will be used to provide behavioral treatment. | Device | Support system users |
Primary outcome
Change in degree of obesity
Time frame: From start of treatment to one year follow-up
Measured by BMI standard deviation score. Support system users vs control
5 secondary outcomes
The use of the support system - weighings
Time frame: From start of treatment to one year follow-up
The use of the support system - text messages
Time frame: From start of treatment to one year follow-up
Number of physical visits
Time frame: From start of treatment to one year follow-up
Number of cancelation of physical visits
Time frame: From start of treatment to one year follow-up
Number of patients not showing up to physical visit
Time frame: From start of treatment to one year follow-up
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 23 Nov 2020.
- Derived from this study: PubMed 35641569Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.
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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, CLINTEC, Division of pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Treatment Adherence, run by Karolinska Institutet at 1 site 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 1 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 23 Nov 2020. 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 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?
Change in degree of obesity (time frame: From start of treatment to one year follow-up). 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 NCT04323215, 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 23 Nov 2020.