CClinicalTrials.gg
Status unknownNCT04013230WebcopUpdated Jul 12, 2019

Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families

An interventional study of Usual care and Web-COP in Childhood Obesity, sponsored by Umeå University. Status unknown at 3 sites in Sweden. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by Umeå University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

The aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents.

The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program and will be offered to children aged 5-12 years with obesity (International Obesity Task Force-BMI >30), and their parents.

Read the detailed description

Obesity in children and adolescents worldwide has increased from 1 % in 1975 to about 6 % in 2016. Experts have estimated that the world will have more obese children and adolescents than underweight at the year 2022. Preventing and reversing excess weight gain in children is important since obesity often tracks into adulthood with adverse health consequences.

Web-based interventions have been shown to be effective, to have a beneficial treatment outcome and have been proposed to have great potential to reach many children and improve cost effectiveness.

This is a randomized controlled study with cross-over design. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program. The control group will have standard care treatment consisting of doctor's appointment and, in some cases, contact with dietician.

02

Conditions studied

  • Childhood Obesity

Keywords

  • Childhood obesity
  • BMI SDS
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Obesity according to International Obesity Task Force (IOTF)
  • Be able to speak and write Swedish
  • Have internet access in parents' home

Exclusion criteria

Exclusion Criteria:

  • Obesity together with other severe disease including neuropsychiatric disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Usual care

    Usual care according to regular treatment routines at the clinic.

    Behavioral: Usual care · Behavioral: Web-COP

  • Active comparator
    Web-COP

    Usual care plus group sessions and a web-based treatment program

    Behavioral: Usual care · Behavioral: Web-COP

Interventions

  • BehavioralUsual care

    Visit doctor and nurse at the clinic.

  • BehavioralWeb-COP

    Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.

06

What researchers measure

Primary outcomes

  1. Change in BMI-SDS

    Controll vs intervention

    Time frame: At baseline, 2, 4 and 6 months

07

Study locations

3 of 3 sites recruiting
  • Outpatient peadictric clinic in Sollefteå hospital
    Sollefteå, 88100, Sweden
    Recruiting
  • Outpatient peadiatric clinic in Sundsvalls hospital
    Sundsvall, 856 43, Sweden
    • Annelie Thorén, PhD · Contact
    Recruiting
  • Umeå university
    Umeå, 901 87, Sweden
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04013230
Lead sponsor
Umeå University
Collaborators
Västernorrland County Council, Sweden
Responsible party
Sponsor
First posted
Jul 9, 2019
Start date
Aug 21, 2019 (estimated)
Primary completion
Aug 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Jul 12, 2019

Study contacts

Annelie Thorén, MD
Contact
annelie.thoren@rvn.se
+46 73 678 65 93
Annika Janson, PhD
Contact
annika.janson@ki.se
Sven-Arne Silfverdal, PhD
principal investigator · Umeå University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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