NCT03233425

Brief Summary

The aim of this pilot project is to disseminate multiprofessional group programs (\*MGP\*) for therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and family behaviours, after the intensive phase (\*T1\*), at 1 and 2 years after start (\*T2\*, \*T3\*). MGP costs are reimbursed in Switzerland: 1) if 116 sessions are provided by experts in physical activity, nutrition and psychology; 2) if parents are included and if their adherence is higher than 85%. In the nationwide "Evaluation of Multiprofessional Group Programs for Paediatric Obesity Therapy" (\*KIDSSTEP\*) study, multiple psychosocial and physical parameters were assessed at T0, T2 and T3 . Out of 33 certified centers, 25 were active and only 19 were re-certified in 2013/2014. Obese children suffer from major co-morbidities and therefore, only one third of referred patients can be treated in MGPs and their beneficial effects on obesity as well as physical and mental health outcomes are sustained over 2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,152

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

4.9 years

First QC Date

March 4, 2015

Last Update Submit

July 25, 2017

Conditions

Overweight

Keywords

Childadolescentco-morbiditypsychologymotivationphysical activityeating disordersquality of lifetherapypredictors

Outcome Measures

Primary Outcomes (1)

  • Body mass index - standard deviation score (*SDS*), (*BMI-SDS*)

    Age- and sex-adjusted BMI according to World Health Organisation (\*WHO\*) charts used in Switzerland

    2 years

Secondary Outcomes (2)

  • Quality of life as assessed by Quality of life questionnaires for children and adolescents (*KIDSSCREEN*) with 52 questions

    2 years

  • Eurofit - Test

    2 years

Interventions

multiprofessional group therapyBEHAVIORAL

Behavioural therapy of lifestyle including activity, family and eating habits

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Overweight children \< 18 years of age

You may qualify if:

  • BMI above the 97th percentile, or in second line waist circumference or fat mass above the nor-mal range, or BMI above the 90th percentile associated with the presence of co-morbidities
  • Medical examination is a pre-requisite
  • Motivation of the patient and support by the family are pre-requisites
  • Psychiatric diseases or severe psychosocial restraints must be adequately tackled.
  • Informed consent of patients and parents to the participation in an anonymous evaluation,

You may not qualify if:

  • healthy child
  • no motivation for therapy, as assessed by interview and questionnaires to Patient and Family
  • psychiatric disease without adequate treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ostschweizer Kinderspital

Sankt Gallen, 9006, Switzerland

Location

MeSH Terms

Conditions

OverweightMotor ActivityFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSigns and Symptoms, DigestiveMental Disorders

Study Officials

  • Dagmar lAllemand, Pr

    Ostschweizer Kinderspital, St. Gallen, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

March 4, 2015

First Posted

July 28, 2017

Study Start

January 1, 2009

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)