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

July 10, 2019 updated by: Umeå University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Sollefteå, Sweden, 88100
        • Recruiting
        • Outpatient peadictric clinic in Sollefteå hospital
        • Contact:
      • Sundsvall, Sweden, 856 43
        • Recruiting
        • Outpatient peadiatric clinic in Sundsvalls hospital
        • Contact:
          • Annelie Thorén, PhD
      • Umeå, Sweden, 901 87

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual care
Usual care according to regular treatment routines at the clinic.
Behavioral: Usual care
Visit doctor and nurse at the clinic.
Behavioral: Web-COP
Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.
ACTIVE_COMPARATOR: Web-COP
Usual care plus group sessions and a web-based treatment program
Behavioral: Usual care
Visit doctor and nurse at the clinic.
Behavioral: Web-COP
Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI-SDS
Time Frame: At baseline, 2, 4 and 6 months
Controll vs intervention
At baseline, 2, 4 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Västernorrland County Council, Sweden

Investigators

  • Principal Investigator: Sven-Arne Silfverdal, PhD, Umea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 21, 2019

Primary Completion (ANTICIPATED)

August 30, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

July 5, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02343

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Obesity

Clinical Trials on Usual care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe