Childhood ObesityNCT06236906
Family Intervention for Treatment of Obesity With Digi-physical Support
A study testing Device supported behavioural treatment in people with Childhood Obesity and mHealth, run by Karolinska Institutet.
Trial summary
Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psycho-social health and early mortality, among many other short- and long-term consequences. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Childhood Obesity, mHealth, Personalized Medicine
- What is being tested?
- Device supported behavioural treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 20 Dec 2024
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- One or more children with obesity. Obesity defined based on the International Task Force criteria iso-BMI 30 and 35.
- At least one parent with obesity, i.e., BMI >30, or overweight with risk factors or comorbidity with a desire and willingness to lose weight.
Who cannot join
- Mental or physical illness in the child or parent that could seriously complicate the study's implementation.
- Serious language barriers preventing written communication in the digital support system.
- Separated parents where collaboration problems may complicate the study's implementation.
- Other reasons assessed to seriously complicate the study's implementation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Digital-Physical Family Intervention in Primary Care for Families With Obesity in Both Children and Adults
Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psycho-social health and early mortality, among many other short- and long-term consequences. In many families where a child has obesity, at least one parent also has obesity or overweight with co-morbidity. In many cases, the care for children is more structured than for adults. Family treatment aimed at making lifestyle changes for the entire family, with those with obesity also restricting their calorie intake to normalize weight, has not been tested in Sweden and on a very limited scale internationally. International studies have shown that the more frequent the contact with healthcare, the better the results, regardless of the treatment method. However, frequent contacts are challenging to implement due to significant demands on both families and healthcare.
To address these challenges, the investigators aim to facilitate, improve, and optimize healthcare using a digital treatment support system involving daily home weighing and electronic communication between the clinic and families via a mobile application. The system is unique as it is based on real measurements, allowing both families and clinical staff to continuously monitor weight changes. This treatment involves fewer physical visits to the clinic but more frequent contact through the digital support system.
The goal is to evaluate whether a digital-physical family treatment conducted in primary care for families with at least one adult and one child with obesity leads to sustained weight loss with fewer visits, fewer missed appointments, resulting in more cost-effective care.
Read the detailed description
The investigators have evaluated a digital support system for childhood obesity. The result shows twice as good results for the children who used the system compared to a control group treated with usual care despite a low frequency of physical clinical visits.
The method involves behavioral change supported by a digital support system, including daily home weighing, a clear weight curve in a mobile app, and communication with the treatment team through the same app. Working with the support system means that, as a caregiver, one follows a clear manual. The core idea is that families, using a partially Motivational Interviewing-based communication approach, find their own ways to reduce excess weight in accordance with what the mobile app indicates. The healthcare provider offers information as needed but refrains from providing specific advice. Instead, the provider supports how to manage the changes. Treatment focuses on the parental role, setting boundaries, collaboration, conflict resolution, and avoiding self-deception.
Over six months, 8-12 families will undergo Family Treatment within primary care. The goal is to evaluate the treatment's effectiveness based on experiences from both families and caregivers, using surveys and semi-structured interviews after three and six months.
- Conditions
- Childhood Obesity, mHealth, Personalized Medicine
- Being tested
- Device supported behavioural treatment
- Keywords
- Obesity treatment, Digital support system
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device supported behavioural treatmentDevice
Also called Evira
The method involves behavioral change supported by a digital support system, including daily home weighings, a clear weight curve in a mobile app, and communication with the treatment team through the same app.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Child and parent in digi-physical family treatment Receives: Device: Device supported behavioural treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Families and practitioners experience of the treatment
Evaluate the experience from both families and practitioners regarding the treatment of the child and parent together with the support of the digital support system. Evira specific questionnaires.
Measured: Baseline, and at three and six months follow-up.
Secondary outcomes (6)
Families adherence to treatment
Number of physical appointments, cancellations, and missed visits.
Measured: Trough study completion, an average of six months.
Families adherence in the use of the digital support system
Frequency of Evira weighings, written and received messages
Measured: Trough study completion, an average of six months.
36-Item Short Form Survey (SF-36) for parents
Questionnaires regarding quality of life. 36-Item Short Form Survey (SF-36) for parents. SF-36 cover eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state.
Measured: Trough study completion, an average of six months.
Pediatric Quality of Life Inventory 4.0 for children (PedsQL)
Pediatric Quality of Life Inventory 4.0 for children (PedsQL). PedsQL is a generic core scales instrument and contain 23-items in four scales, physical functioning, emotional functioning, social functioning, and school functioning. The higher scores indicate better health-related quality of life.
Measured: Trough study completion, an average of six months.
Participants', the children and parents psycho-social health during the family treatment
Questionnaires regarding negative side effects such as the occurrence of eating disorders, anxiety, or depression (Evira specific questionnaires).
Measured: Trough study completion, an average of six months.
Change in BMI
Weight and height will be combined to report BMI in kg/m^2 for analyzing change in BMI Standard Deviation Score for the child and BMI for the parent.
Measured: At three and six months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
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
- NCT06236906
- Sponsor's protocol ID
- FamEv2024
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Using the evaluation from this study, we aim to optimize the family treatment method and finalize the application design based on user experiences for a larger randomized trial. as there are few individuals from a small place in Sweden, it will be difficult to keep the data anonymous.
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 32967638Hagman 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital-Physical Family Intervention in Primary Care for Families With Obesity in Both Children and Adults
- ClinicalTrials.gov ID
- NCT06236906
- Acronym / sponsor ID
- FamEv2024
- Conditions
- Childhood Obesity, mHealth, Personalized Medicine
- Keywords
- Obesity treatment, Digital support system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 1 Feb 2024 (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.
Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psycho-social health and early mortality, among many other short- and long-term consequences. In many families where a child has obesity, at least one parent also has obesity or overweight with co-morbidity. In many cases, the care for children is more structured than for adults. Family treatment aimed at making lifestyle changes for the entire family, with those with obesity also restricting their calorie intake to normalize weight, has not been tested in Sweden and on a very limited scale internationally. International studies have shown that the more frequent the contact with healthcare, the better the results, regardless of the treatment method. However, frequent contacts are challenging to implement due to significant demands on both families and healthcare.
To address these challenges, the investigators aim to facilitate, improve, and optimize healthcare using a digital treatment support system involving daily home weighing and electronic communication between the clinic and families via a mobile application. The system is unique as it is based on real measurements, allowing both families and clinical staff to continuously monitor weight changes. This treatment involves fewer physical visits to the clinic but more frequent contact through the digital support system.
The goal is to evaluate whether a digital-physical family treatment conducted in primary care for families with at least one adult and one child with obesity leads to sustained weight loss with fewer visits, fewer missed appointments, resulting in more cost-effective care.
Detailed description
The investigators have evaluated a digital support system for childhood obesity. The result shows twice as good results for the children who used the system compared to a control group treated with usual care despite a low frequency of physical clinical visits.
The method involves behavioral change supported by a digital support system, including daily home weighing, a clear weight curve in a mobile app, and communication with the treatment team through the same app. Working with the support system means that, as a caregiver, one follows a clear manual. The core idea is that families, using a partially Motivational Interviewing-based communication approach, find their own ways to reduce excess weight in accordance with what the mobile app indicates. The healthcare provider offers information as needed but refrains from providing specific advice. Instead, the provider supports how to manage the changes. Treatment focuses on the parental role, setting boundaries, collaboration, conflict resolution, and avoiding self-deception.
Over six months, 8-12 families will undergo Family Treatment within primary care. The goal is to evaluate the treatment's effectiveness based on experiences from both families and caregivers, using surveys and semi-structured interviews after three and six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Device supported behavioural treatmentChild and parent in digi-physical family treatment |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- One or more children with obesity. Obesity defined based on the International Task Force criteria iso-BMI 30 and 35.
- At least one parent with obesity, i.e., BMI >30, or overweight with risk factors or comorbidity with a desire and willingness to lose weight.
Key exclusion criteria (4 listed)
- Mental or physical illness in the child or parent that could seriously complicate the study's implementation.
- Serious language barriers preventing written communication in the digital support system.
- Separated parents where collaboration problems may complicate the study's implementation.
- Other reasons assessed to seriously complicate the study's implementation.
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 |
|---|---|---|
| Device supported behavioural treatmentAlso: EviraThe method involves behavioral change supported by a digital support system, including daily home weighings, a clear weight curve in a mobile app, and communication with the treatment team through the same app. | Device | Intervention |
Primary outcome
Families and practitioners experience of the treatment
Time frame: Baseline, and at three and six months follow-up.
Evaluate the experience from both families and practitioners regarding the treatment of the child and parent together with the support of the digital support system. Evira specific questionnaires.
6 secondary outcomes
Families adherence to treatment
Time frame: Trough study completion, an average of six months.
Families adherence in the use of the digital support system
Time frame: Trough study completion, an average of six months.
36-Item Short Form Survey (SF-36) for parents
Time frame: Trough study completion, an average of six months.
Pediatric Quality of Life Inventory 4.0 for children (PedsQL)
Time frame: Trough study completion, an average of six months.
Participants', the children and parents psycho-social health during the family treatment
Time frame: Trough study completion, an average of six months.
Change in BMI
Time frame: At three and six months follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: 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.
- Background: 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.
- Evira homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Using the evaluation from this study, we aim to optimize the family treatment method and finalize the application design based on user experiences for a larger randomized trial. as there are few individuals from a small place in Sweden, it will be difficult to keep the data anonymous.
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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
Questions about this trial
What is this clinical trial studying?
A study testing Device supported behavioural treatment in people with Childhood Obesity and mHealth, run by Karolinska Institutet.
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 2 inclusion and 4 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Pernilla Danielsson, PhD (+46 708377734, pernilla.danielsson-liljeqvist@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Families and practitioners experience of the treatment (time frame: Baseline, and at three and six months 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 NCT06236906, which also lists 2 linked publications.
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 1 Feb 2024.