Pediatric ObesityOBDIPHYNCT05247918
OBDIPHY (OBesity DIgital-PHYsical Care Study)
A study testing Digital-physical care and Treatment as usual in people with Pediatric Obesity and Obesity, run by Göteborg University at 5 sites in Sweden.
Trial summary
This is a prospective randomized controlled multicentre non-inferiority trial. The aim of this study to evaluate digi-physical care compared to regular physical/in person care and investigate if digi-physical care can be an equal or even better treatment alternative among families with children or adolescents living… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Pediatric Obesity, Obesity, Adolescent Obesity
- What is being tested?
- Digital-physical care and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 5 sitesSweden
- Study dates
- 9 Mar 2022to 30 May 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ISO-BMI 30 or above.
Who cannot join
- Lack of Swedish skills
- Patients potential for obesity surgery
- Patient with obesity syndrome
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Regionalt obesitascentrum
Gothenburg
Barnkliniken Halland
Halmstad
Barnkliniken Halland
Kungsbacka
Överviktenheten Barn
Malmö
Barnkliniken Halland
Varberg
About this study
Official title: OBDIPHY (OBesity DIgital-PHYsical Care Study) - Effects of Digi-physical Care for Families
This is a prospective randomized controlled multicentre non-inferiority trial. The aim of this study to evaluate digi-physical care compared to regular physical/in person care and investigate if digi-physical care can be an equal or even better treatment alternative among families with children or adolescents living with obesity in Sweden. The study participants will either get treatment as usual or treatment as usual combined with digi-physical solution. The digi-physical solution includes thar half of the session is digital and they get an app where they can self-monitoring health data, have an overview over they treatment plan and easy communicate with theirs caregivers.
Read the detailed description
This study is multi centre in three different county council in southwest of Sweden which include children and adolescents in the age of 10-16 year. The study participants will either get treatment as usual, which includes four in person session with healthcare professionals as doctor, nurse or dietitian (the control group) or treatment as usual combined with digi-physical solution (intervention group). The intervention group will beyond treatment as usual get a digital communication platform (including an app) where the patient has a good overview of their treatment plan, can report self-monitored health data as daily steps and weight once a week and monitor the daily work with their selected health goal. Everything in the app is individually tailored together with the patient. The patient with digi-physical care will also have assess to a chat for communication with their caregivers. The app has a high degree of authentication and classified as a journal system. Half of yearly treatment as usual sessions will be digital for the intervention group.
The digi-physical method of treatment is developed and based on the desire from the patient association HOBS (hälsa oberoende av storlek). In parts of Sweden people have long distance to the clinic which makes it difficult to be present at the treatment in-clinic sessions and the families loses many hours away from school and work. The null hypothesis is that digi-physical care will have a positive effect on BMI SDS, however inferior to treatment as usual.
In addition to evaluate that this new treatment alternative is safe will also ISO-BMI, weight development and metabolic risk factors be evaluated. The study does not include any extra blood samples or visits to the clinic thus everything is collected according to regular care programs. To evaluate the food intake and possible changes there will be three 24-h recalls, combined with riksmaten flex, performed. There will also be questions about their physical activity and a survey (PEDS-QL) for mental health. For a few volunteered patient families, approximate 15-20, will participate in semi-structured deep interviews.
- Conditions
- Pediatric Obesity, Obesity, Adolescent Obesity, Lifestyle Risk Reduction, Metabolic Syndrome, Weight Loss
- Being tested
- Digital-physical care, Treatment as usual
- Medical subject headings
- Pediatric Obesity, Obesity, Risk Reduction Behavior, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital-physical careBehavioural
Patients will get access to a digital communication platform. Two in person session and two digital contacts per year with possibility to chat with caregivers in between.
Treatment as usualBehavioural
Four in person session at the center in a year.
| Study group | Role | What they receive |
|---|---|---|
| Digital-physical care group | Experimental | Combination of digital and physical care. Receives: Behavioral: Digital-physical care |
| Treatment as usual. | Active comparator | Treatment as usual in accordance with national guidelines. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BMI standard deviation score at month 12.
The BMI standard-deviation score is a measure of the number of standard deviations from the population mean BMI (weight divided by height squared), matched for age and sex.
Measured: Baseline and month 12.
Secondary outcomes (28)
Change from baseline in BMI standard deviation score at month 6.
The BMI standard-deviation score is a measure of the number of standard deviations from the population mean BMI (weight divided by height squared), matched for age and sex.
Measured: Baseline and month 6.
Change from baseline in BMI standard deviation score at month 18.
The BMI standard-deviation score is a measure of the number of standard deviations from the population mean BMI (weight divided by height squared), matched for age and sex.
Measured: Baseline and month 18
Change from baseline in weight at month 3.
Weight in kilogram measure in clinic at the hospital scales from TANITA or self monitored at home on a Beurer BF 850 scale.
Measured: Baseline and month 3.
Change from baseline in weight at month 6.
Weight in kilogram measure in clinic at the hospital scales from TANITA or self monitored at home on a Beurer BF 850 scale.
Measured: Baseline and month 6.
Change from baseline in weight at month 9.
Weight in kilogram measure in clinic at the hospital scales from TANITA or self monitored at home on a Beurer BF 850 scale.
Measured: Baseline and month 9..
Change from baseline in weight at month 12.
Weight in kilogram measure in clinic at the hospital scales from TANITA or self monitored at home on a Beurer BF 850 scale.
Measured: Baseline and month 12.
Change from baseline in weight at month 18.
Weight in kilogram measure in clinic at the hospital scales from TANITA or self monitored at home on a Beurer BF 850 scale.
Measured: Baseline and month 18.
Change from baseline in waist circumference at 6 and 12 month.
Waist circumference measure in cm with measuring tape.
Measured: Baseline and month 6 and 12.
Change from baseline in waist circumference at 6 month.
Waist circumference measure in cm with measuring tape.
Measured: Baseline and month 6.
Change from baseline in blood pressure at12 month.
Bloodpressure in mm Hg, measured in right arm while sitting down after 5 minits of rest. It will be measured three times and then the mean of the two last measure will be calculated and reported.
Measured: Baseline and month 12.
Change from baseline in fasting insulin at 12 month.
Fasting insulin from blood sample measured in mU/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in fasting glucose at 12 month.
Fasting glucose from blood sample measured in mmol/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in HbA1c at 12 month.
HbA1c from blood sample measured in mmol/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in lever enzymes, ASAT, at 12 month.
ASAT from blood sample measured in µkat/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in lever enzymes, ALAT, at 12 month.
ALAT from blood sample measured in µkat/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in triglyceride at 12 month.
Triglyceride from blood sample measured in mmol/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in cholesterol at 12 month.
Cholesterol from blood sample measured in mmol/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in blood lipid, LDL, at 12 month.
LDL from blood sample measured in mmol/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in blood lipid, HDL, at 12 month.
HDL from blood sample measured in mmol/L. Analyzed according to standard routine.
Measured: Baseline and month 12.
Change from baseline in food intake according to Riksmaten Flex and 24-hour recalls in 12 month.
RiksmatenFlex and 24-hour recalls is a validated survey about food habits combined with three 24-hour interviews, where food intake the last 24 h are reported.
Measured: Baseline and month 12.
Change from baseline in amount of steps per day according to activity watch at week 52.
Amount of daily steps will be self-monitored with a sportsbuddy veryfit activity watch and then selfreported in to the study app. The mean of one weeks step will be colected at week 1, 26 and 52.
Measured: Baseline (week 1) and 52.
Change from baseline in amount of steps per day according to activity watch at week 26.
Amount of daily steps will be self-monitored with a sportsbuddy veryfit activity watch and then selfreported in to the study app. The mean of one weeks step will be collected at week 1, 26 and 52.
Measured: Baseline (week 1) and week 26.
Change from baseline in health-related quality of life according to PEDS-QL at 12 month
PEDS-QL is a valid questionaire for evaluating health-related quality of life used by the Swedish childhood obesity treatment register (BORIS). The child will answer if they never, almost never, sometimes, often or always has experience diffrent issues conserning their health.
Measured: Baseline and month 12.
Change from baseline in daily well-being on a 10 point VAS-scale at week 26.
Daily self reported well-being via a VAS-scale from 1-10 (1=worst feeling, 10=best feeling). The mean of one week reported data will be collected at week 1, 26 and 52.
Measured: Baseline (week 1), and week 26.
Change from baseline in daily well-being on a 10 point VAS-scale at week 52.
Daily self reported well-being via a VAS-scale from 1-10 (1=worst feeling, 10=best feeling). The mean of one week reported data will be collected at week 1, 26 and 52.
Measured: Baseline (week 1) and 52.
Thoughts on implementation from caregivers after a 12-month digital-physical care.
Survey about caregivers experience through implementation of digital care. Few easy questions about positive and negative aspects.
Measured: At month 12
Thoughts on implementation from patients after a 12-month digital-physical care.
Survey about patient experience through implementation of digital care. Few easy questions about positive and negative aspects and how they used the app.
Measured: At month 12
Semi-structured interviews for a deeper insight in the qualitative aspects concerning digital care.
Semi-structured interviews with 15-20 of the patient families inte the intervention group. The interview will proceed from open answer questions with the possibility to expand answers.
Measured: At month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start9 Mar 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- 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
- Model description
- Multicenter prospective randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Vastra Gotaland Region, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Josefin Roswall, Study chair, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247918
- Sponsor's protocol ID
- 276515
- Acronym
- OBDIPHY
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2021
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBDIPHY (OBesity DIgital-PHYsical Care Study) - Effects of Digi-physical Care for Families
- ClinicalTrials.gov ID
- NCT05247918
- Acronym / sponsor ID
- OBDIPHY / 276515
- Conditions
- Pediatric Obesity, Obesity, Adolescent Obesity, Lifestyle Risk Reduction, Metabolic Syndrome, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Region Skane, Vastra Gotaland Region, Karolinska Institutet
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 21 Feb 2022 (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 is a prospective randomized controlled multicentre non-inferiority trial. The aim of this study to evaluate digi-physical care compared to regular physical/in person care and investigate if digi-physical care can be an equal or even better treatment alternative among families with children or adolescents living with obesity in Sweden. The study participants will either get treatment as usual or treatment as usual combined with digi-physical solution. The digi-physical solution includes thar half of the session is digital and they get an app where they can self-monitoring health data, have an overview over they treatment plan and easy communicate with theirs caregivers.
Detailed description
This study is multi centre in three different county council in southwest of Sweden which include children and adolescents in the age of 10-16 year. The study participants will either get treatment as usual, which includes four in person session with healthcare professionals as doctor, nurse or dietitian (the control group) or treatment as usual combined with digi-physical solution (intervention group). The intervention group will beyond treatment as usual get a digital communication platform (including an app) where the patient has a good overview of their treatment plan, can report self-monitored health data as daily steps and weight once a week and monitor the daily work with their selected health goal. Everything in the app is individually tailored together with the patient. The patient with digi-physical care will also have assess to a chat for communication with their caregivers. The app has a high degree of authentication and classified as a journal system. Half of yearly treatment as usual sessions will be digital for the intervention group.
The digi-physical method of treatment is developed and based on the desire from the patient association HOBS (hälsa oberoende av storlek). In parts of Sweden people have long distance to the clinic which makes it difficult to be present at the treatment in-clinic sessions and the families loses many hours away from school and work. The null hypothesis is that digi-physical care will have a positive effect on BMI SDS, however inferior to treatment as usual.
In addition to evaluate that this new treatment alternative is safe will also ISO-BMI, weight development and metabolic risk factors be evaluated. The study does not include any extra blood samples or visits to the clinic thus everything is collected according to regular care programs. To evaluate the food intake and possible changes there will be three 24-h recalls, combined with riksmaten flex, performed. There will also be questions about their physical activity and a survey (PEDS-QL) for mental health. For a few volunteered patient families, approximate 15-20, will participate in semi-structured deep interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter prospective randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Digital-physical care group | Experimental | Behavioral: Digital-physical careCombination of digital and physical care. |
| Treatment as usual. | Active comparator | Behavioral: Treatment as usualTreatment as usual in accordance with national guidelines. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ISO-BMI 30 or above.
Key exclusion criteria (3 listed)
- Lack of Swedish skills
- Patients potential for obesity surgery
- Patient with obesity syndrome
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 |
|---|---|---|
| Digital-physical carePatients will get access to a digital communication platform. Two in person session and two digital contacts per year with possibility to chat with caregivers in between. | Behavioural | Digital-physical care group |
| Treatment as usualFour in person session at the center in a year. | Behavioural | Treatment as usual. |
Primary outcome
Change from baseline in BMI standard deviation score at month 12.
Time frame: Baseline and month 12.
The BMI standard-deviation score is a measure of the number of standard deviations from the population mean BMI (weight divided by height squared), matched for age and sex.
28 secondary outcomes
Change from baseline in BMI standard deviation score at month 6.
Time frame: Baseline and month 6.
Change from baseline in BMI standard deviation score at month 18.
Time frame: Baseline and month 18
Change from baseline in weight at month 3.
Time frame: Baseline and month 3.
Change from baseline in weight at month 6.
Time frame: Baseline and month 6.
Change from baseline in weight at month 9.
Time frame: Baseline and month 9..
Change from baseline in weight at month 12.
Time frame: Baseline and month 12.
Change from baseline in weight at month 18.
Time frame: Baseline and month 18.
Change from baseline in waist circumference at 6 and 12 month.
Time frame: Baseline and month 6 and 12.
Change from baseline in waist circumference at 6 month.
Time frame: Baseline and month 6.
Change from baseline in blood pressure at12 month.
Time frame: Baseline and month 12.
Change from baseline in fasting insulin at 12 month.
Time frame: Baseline and month 12.
Change from baseline in fasting glucose at 12 month.
Time frame: Baseline and month 12.
Change from baseline in HbA1c at 12 month.
Time frame: Baseline and month 12.
Change from baseline in lever enzymes, ASAT, at 12 month.
Time frame: Baseline and month 12.
Change from baseline in lever enzymes, ALAT, at 12 month.
Time frame: Baseline and month 12.
Change from baseline in triglyceride at 12 month.
Time frame: Baseline and month 12.
Change from baseline in cholesterol at 12 month.
Time frame: Baseline and month 12.
Change from baseline in blood lipid, LDL, at 12 month.
Time frame: Baseline and month 12.
Change from baseline in blood lipid, HDL, at 12 month.
Time frame: Baseline and month 12.
Change from baseline in food intake according to Riksmaten Flex and 24-hour recalls in 12 month.
Time frame: Baseline and month 12.
Change from baseline in amount of steps per day according to activity watch at week 52.
Time frame: Baseline (week 1) and 52.
Change from baseline in amount of steps per day according to activity watch at week 26.
Time frame: Baseline (week 1) and week 26.
Change from baseline in health-related quality of life according to PEDS-QL at 12 month
Time frame: Baseline and month 12.
Change from baseline in daily well-being on a 10 point VAS-scale at week 26.
Time frame: Baseline (week 1), and week 26.
Change from baseline in daily well-being on a 10 point VAS-scale at week 52.
Time frame: Baseline (week 1) and 52.
Thoughts on implementation from caregivers after a 12-month digital-physical care.
Time frame: At month 12
Thoughts on implementation from patients after a 12-month digital-physical care.
Time frame: At month 12
Semi-structured interviews for a deeper insight in the qualitative aspects concerning digital care.
Time frame: At month 12.
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 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Josefin Roswall study chair
Region Halland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital-physical care and Treatment as usual in people with Pediatric Obesity and Obesity, run by Göteborg University at 5 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 1 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Change from baseline in BMI standard deviation score at month 12. (time frame: Baseline and month 12.). 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 17 Mar 2026.