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

Childhood Obesity Clinical Trial

— Webcop  

Official title:

Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families - a Randomized Controlled Trial of Children With Obesity in Northern Sweden

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04013230
• Other study ID #: 2019-02343
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2019
• Source: Umeå University
• Contact: Annelie Thorén, MD
• Phone: +46 73 678 65 93
• Email: annelie.thoren[@]rvn.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Usual care
Visit doctor and nurse at the clinic.
• Web-COP
Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.

Locations

Country	Name	City	State
Sweden	Outpatient peadictric clinic in Sollefteå hospital	Sollefteå
Sweden	Outpatient peadiatric clinic in Sundsvalls hospital	Sundsvall
Sweden	Umeå university	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Västernorrland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI-SDS	Controll vs intervention	At baseline, 2, 4 and 6 months