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OBDIPHY (OBesity DIgital-PHYsical Care Study)

NCT05247918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Pediatric Obesity
  • Obesity
  • Adolescent Obesity
  • Lifestyle Risk Reduction
  • Metabolic Syndrome
  • Weight Loss

Interventions

BEHAVIORAL

Digital-physical care

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.

BEHAVIORAL

Treatment as usual

Four in person session at the center in a year.

Sponsors & Collaborators

  • Region Skane

    collaborator OTHER

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Karolinska Institutet

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Josefin Roswall · Region Halland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247918 on ClinicalTrials.gov