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

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ClinicalTrials.gov Identifier: NCT04013230
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Västernorrland County Council, Sweden
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Usual care Behavioral: Web-COP Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 21, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 30, 2020

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.




Primary Outcome Measures :
  1. Change in BMI-SDS [ Time Frame: At baseline, 2, 4 and 6 months ]
    Controll vs intervention



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013230


Contacts
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Contact: Annelie Thorén, MD +46 73 678 65 93 annelie.thoren@rvn.se
Contact: Annika Janson, PhD annika.janson@ki.se

Locations
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Sweden
Outpatient peadictric clinic in Sollefteå hospital Recruiting
Sollefteå, Sweden, 88100
Contact: Annelie Thorén, PhD       annelie.thoren@rvn.se   
Outpatient peadiatric clinic in Sundsvalls hospital Recruiting
Sundsvall, Sweden, 856 43
Contact: Annelie Thorén, PhD         
Umeå university Recruiting
Umeå, Sweden, 901 87
Contact: Sven-Arne Silfverdal, MD    +46 70 764 05 87    sven-arne.silfverdal@umu.se   
Sponsors and Collaborators
Umeå University
Västernorrland County Council, Sweden
Investigators
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Principal Investigator: Sven-Arne Silfverdal, PhD Umeå University

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT04013230     History of Changes
Other Study ID Numbers: 2019-02343
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Umeå University:
Childhood obesity
BMI SDS

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms