NCT05247918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

March 17, 2026

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

December 7, 2021

Last Update Submit

March 13, 2026

Conditions

Pediatric ObesityObesityAdolescent ObesityLifestyle Risk ReductionMetabolic SyndromeWeight Loss

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and month 12.

Secondary Outcomes (28)

  • Change from baseline in BMI standard deviation score at month 6.

    Baseline and month 6.

  • Change from baseline in BMI standard deviation score at month 18.

    Baseline and month 18

  • Change from baseline in weight at month 3.

    Baseline and month 3.

  • Change from baseline in weight at month 6.

    Baseline and month 6.

  • Change from baseline in weight at month 9.

    Baseline and month 9..

  • +23 more secondary outcomes

Other Outcomes (1)

  • Report digital selfmonitored health data.

    At 3 month.

Study Arms (2)

Digital-physical care group

EXPERIMENTAL

Combination of digital and physical care.

Behavioral: Digital-physical care

Treatment as usual.

ACTIVE COMPARATOR

Treatment as usual in accordance with national guidelines.

Behavioral: Treatment as usual

Interventions

Digital-physical careBEHAVIORAL

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.

Digital-physical care group
Treatment as usualBEHAVIORAL

Four in person session at the center in a year.

Treatment as usual.

Eligibility Criteria

Age10 Years - 16 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ISO-BMI 30 or above.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Regionalt obesitascentrum

Gothenburg, Sweden

Location

Barnkliniken Halland

Halmstad, Sweden

Location

Barnkliniken Halland

Kungsbacka, Sweden

Location

Överviktenheten Barn

Malmo, Sweden

Location

Barnkliniken Halland

Varberg, Sweden

Location

MeSH Terms

Conditions

Pediatric ObesityObesityRisk Reduction BehaviorMetabolic SyndromeWeight Loss

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBody Weight Changes

Study Officials

  • Josefin Roswall

    Region Halland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter prospective randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

February 21, 2022

Study Start

March 9, 2022

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

March 17, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(5)