NCT04013230

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 5, 2019

Last Update Submit

July 10, 2019

Conditions

Childhood Obesity

Keywords

Childhood obesityBMI SDS

Outcome Measures

Primary Outcomes (1)

  • Change in BMI-SDS

    Controll vs intervention

    At baseline, 2, 4 and 6 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care according to regular treatment routines at the clinic.

Behavioral: Usual careBehavioral: Web-COP

Web-COP

ACTIVE COMPARATOR

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

Behavioral: Usual careBehavioral: Web-COP

Interventions

Usual careBEHAVIORAL

Visit doctor and nurse at the clinic.

Usual careWeb-COP
Web-COPBEHAVIORAL

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

Usual careWeb-COP

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Obesity according to International Obesity Task Force (IOTF)
  • Be able to speak and write Swedish
  • Have internet access in parents' home

You may not qualify if:

  • Obesity together with other severe disease including neuropsychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Outpatient peadictric clinic in Sollefteå hospital

Sollefteå, 88100, Sweden

RECRUITING

Outpatient peadiatric clinic in Sundsvalls hospital

Sundsvall, 856 43, Sweden

RECRUITING

Umeå university

Umeå, 901 87, Sweden

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sven-Arne Silfverdal, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelie Thorén, MD

CONTACT

+46 73 678 65 93annelie.thoren@rvn.se

Annika Janson, PhD

CONTACT

annika.janson@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 9, 2019

Study Start

August 21, 2019

Primary Completion

August 30, 2020

Study Completion

December 30, 2020

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

SE(3)