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

NCT ID: NCT04013230

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-21

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Usual care according to regular treatment routines at the clinic.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Visit doctor and nurse at the clinic.

Web-COP

Intervention Type BEHAVIORAL

Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.

Web-COP

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Visit doctor and nurse at the clinic.

Web-COP

Intervention Type BEHAVIORAL

Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.

Interventions

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Usual care

Visit doctor and nurse at the clinic.

Intervention Type BEHAVIORAL

Web-COP

Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Västernorrland County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sven-Arne Silfverdal, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Outpatient peadictric clinic in Sollefteå hospital

Sollefteå, , Sweden

Site Status RECRUITING

Outpatient peadiatric clinic in Sundsvalls hospital

Sundsvall, , Sweden

Site Status RECRUITING

Umeå university

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Annelie Thorén, MD

Role: CONTACT

+46 73 678 65 93

Annika Janson, PhD

Role: CONTACT

Facility Contacts

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Annelie Thorén, PhD

Role: primary

Annelie Thorén, PhD

Role: primary

Sven-Arne Silfverdal, MD

Role: primary

+46 70 764 05 87

Other Identifiers

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2019-02343

Identifier Type: -

Identifier Source: org_study_id

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