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

Not Applicable

• Conditions: Childhood Obesity
• Interventions: Behavioral: Usual care; Behavioral: Web-COP

• Registration Number: NCT04013230
• Lead Sponsor: Umeå University

Brief 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.

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-09
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12
• Study Start: 2019-08-21
• Primary Completion: 2020-08-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Obesity together with other severe disease including neuropsychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Web-COP	Usual care	Usual care plus group sessions and a web-based treatment program
Usual care	Web-COP	Usual care according to regular treatment routines at the clinic.
Usual care	Usual care	Usual care according to regular treatment routines at the clinic.
Web-COP	Web-COP	Usual care plus group sessions and a web-based treatment program

Primary Outcome Measures

Name	Time	Method
Change in BMI-SDS	At baseline, 2, 4 and 6 months	Controll vs intervention

Trial Locations

Locations (3)

Outpatient peadiatric clinic in Sundsvalls hospital; 🇸🇪 Sundsvall, Sweden

Umeå university; 🇸🇪 Umeå, Sweden

Outpatient peadictric clinic in Sollefteå hospital; 🇸🇪 Sollefteå, Sweden