Clinical trial NCT05247918: OBDIPHY (OBesity DIgital-PHYsical Care Study)
Official title: OBDIPHY (OBesity DIgital-PHYsical Care Study) - Effects of Digi-physical Care for Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Obesity
Adolescent Obesity
Lifestyle Risk Reduction
Metabolic Syndrome
Weight Loss
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Region Skane
name: Vastra Gotaland Region
name: Karolinska Institutet
First posted: 2022-02-21
Enrollment: 102
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter prospective randomized controlled trial.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* ISO-BMI 30 or above.

Exclusion Criteria:

* Lack of Swedish skills
* Patients potential for obesity surgery
* Patient with obesity syndrome

Primary outcomes:
measure: Change from baseline in BMI standard deviation score at month 12.
timeFrame: Baseline and month 12.
Secondary outcomes:
measure: Change from baseline in BMI standard deviation score at month 6.
timeFrame: Baseline and month 6.
measure: Change from baseline in BMI standard deviation score at month 18.
timeFrame: Baseline and month 18
measure: Change from baseline in weight at month 3.
timeFrame: Baseline and month 3.
measure: Change from baseline in weight at month 6.
timeFrame: Baseline and month 6.
measure: Change from baseline in weight at month 9.
timeFrame: Baseline and month 9..
measure: Change from baseline in weight at month 12.
timeFrame: Baseline and month 12.
measure: Change from baseline in weight at month 18.
timeFrame: Baseline and month 18.
measure: Change from baseline in waist circumference at 6 and 12 month.
timeFrame: Baseline and month 6 and 12.
measure: Change from baseline in waist circumference at 6 month.
timeFrame: Baseline and month 6.
measure: Change from baseline in blood pressure at12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in fasting insulin at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in fasting glucose at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in HbA1c at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in lever enzymes, ASAT, at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in lever enzymes, ALAT, at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in triglyceride at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in cholesterol at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in blood lipid, LDL, at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in blood lipid, HDL, at 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in food intake according to Riksmaten Flex and 24-hour recalls in 12 month.
timeFrame: Baseline and month 12.
measure: Change from baseline in amount of steps per day according to activity watch at week 52.
timeFrame: Baseline (week 1) and 52.
measure: Change from baseline in amount of steps per day according to activity watch at week 26.
timeFrame: Baseline (week 1) and week 26.
measure: Change from baseline in health-related quality of life according to PEDS-QL at 12 month
timeFrame: Baseline and month 12.
measure: Change from baseline in daily well-being on a 10 point VAS-scale at week 26.
timeFrame: Baseline (week 1), and week 26.
measure: Change from baseline in daily well-being on a 10 point VAS-scale at week 52.
timeFrame: Baseline (week 1) and 52.
measure: Thoughts on implementation from caregivers after a 12-month digital-physical care.
timeFrame: At month 12
measure: Thoughts on implementation from patients after a 12-month digital-physical care.
timeFrame: At month 12
measure: Semi-structured interviews for a deeper insight in the qualitative aspects concerning digital care.
timeFrame: At month 12.
Other outcomes:
measure: Report digital selfmonitored health data.
timeFrame: At 3 month.
Locations:
city: Göteborg
country: Sweden
facility: Regionalt obesitascentrum
city: Halmstad
country: Sweden
facility: Barnkliniken Halland
city: Kungsbacka
country: Sweden
facility: Barnkliniken Halland
city: Malmö
country: Sweden
facility: Överviktenheten Barn
city: Varberg
country: Sweden
facility: Barnkliniken Halland
Study officials:
affiliation: Region Halland
name: Josefin Roswall
role: STUDY_CHAIR
References: