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

Primary Purpose

Childhood Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Usual care
Web-COP
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood obesity, BMI SDS

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Outpatient peadictric clinic in Sollefteå hospitalRecruiting
  • Outpatient peadiatric clinic in Sundsvalls hospitalRecruiting
  • Umeå universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual care

Web-COP

Arm Description

Usual care according to regular treatment routines at the clinic.

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

Outcomes

Primary Outcome Measures

Change in BMI-SDS
Controll vs intervention

Secondary Outcome Measures

Full Information

First Posted
July 5, 2019
Last Updated
July 10, 2019
Sponsor
Umeå University
Collaborators
Västernorrland County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04013230
Brief Title
Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2019 (Anticipated)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Västernorrland County Council, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood obesity, BMI SDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care according to regular treatment routines at the clinic.
Arm Title
Web-COP
Arm Type
Active Comparator
Arm Description
Usual care plus group sessions and a web-based treatment program
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Visit doctor and nurse at the clinic.
Intervention Type
Behavioral
Intervention Name(s)
Web-COP
Intervention Description
Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.
Primary Outcome Measure Information:
Title
Change in BMI-SDS
Description
Controll vs intervention
Time Frame
At baseline, 2, 4 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annelie Thorén, MD
Phone
+46 73 678 65 93
Email
annelie.thoren@rvn.se
First Name & Middle Initial & Last Name or Official Title & Degree
Annika Janson, PhD
Email
annika.janson@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven-Arne Silfverdal, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient peadictric clinic in Sollefteå hospital
City
Sollefteå
ZIP/Postal Code
88100
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelie Thorén, PhD
Email
annelie.thoren@rvn.se
Facility Name
Outpatient peadiatric clinic in Sundsvalls hospital
City
Sundsvall
ZIP/Postal Code
856 43
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelie Thorén, PhD
Facility Name
Umeå university
City
Umeå
ZIP/Postal Code
901 87
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven-Arne Silfverdal, MD
Phone
+46 70 764 05 87
Email
sven-arne.silfverdal@umu.se

12. IPD Sharing Statement

Learn more about this trial

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

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