OBDIPHY (OBesity DIgital-PHYsical Care Study)

Göteborg University

Status: Completed

Conditions: Weight Loss; Lifestyle Risk Reduction; Obesity; Pediatric Obesity; Adolescent Obesity; Metabolic Syndrome

Treatments: Behavioral: Treatment as usual; Behavioral: Digital-physical care

Study type: Interventional

Funder types: Other

Identifiers

NCT05247918

276515

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ISO-BMI 30 or above.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Digital-physical care group

Experimental group

Description:

Combination of digital and physical care.

Treatment:

Behavioral: Digital-physical care

Treatment as usual.

Active Comparator group

Description:

Treatment as usual in accordance with national guidelines.

Treatment:

Behavioral: Treatment as usual