Evaluation of Multiprofessional Group Programs for Paediatric Obesity Therapy (KIDSSTEP)

July 25, 2017 updated by: Dagmar l'Allemand, Ostschweizer Kinderspital

Evaluation of Therapy for Overweight Children and Adolescents in Switzerland: Therapy in Multiprofessional Group Programs - Part 2, Collection and Analysis of Data

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In Switzerland, the number of overweight children <18 years is estimated to 80'000 and related cardiovascular, osteoarticular and other complications are already present in approximately in 50% of these youth. Controlled studies demonstrated that multiprofessional treatment programs can reduce adiposity and improve health risk factors. To pre-empt the deterioration of obesity and co-morbidities in adult life, the Swiss Department of the Interior (EDI) approved in 2007 the reimbursement of treatment of overweight children by health insurances , if conducted in certified multi-professional family-based group programs. All programs have to participate in a scientific evaluation study supported by the Federal Office of Public Health (FOPH) in order to determine nationwide outcomes in clinical practice. The goal of this study is to evaluate individual changes of physical activity, nutrition, behaviours, quality of life, co-morbidities and adiposity during therapy and to identify predictors of positive or negative changes.

During 5 years, the investigators will recruit about 200 children and adolescents aged 6 to 18 years every year. Patients must have a Body Mass Index (BMI), fat mass or waist circumference above the 97th percentile, or a BMI above the 90th percentile plus a co-morbidity. Together with their parents they will be enrolled in an intensive group therapy program for 6 to 12 months, with 12 months of follow up. To date, in 25 certified centres, physicians, nutrition and physical activity specialists as well as psychologists can provide a multiprofessional standardized care, the costs of participation being reimbursed after regular presence. At start, after 1 year and 2 years, standardized instruments validated in Swiss or European children will be used to document changes during therapy. Questionnaires will assess motivation, weight of parents, personal and family history, quality of life, child and family lifestyle, parenting skills, eating or psychological disorders, and satisfaction. Other investigations will include medical examination, blood tests, and European Fitness (*Eurofit*)-test for physical fitness and capacities. Anonymised data will be recorded centrally in an electronic database, after controlling for completeness and plausibility. Informed consent and positive votes of local ethical committees will be obtained. Reports on cross-sectional and longitudinal descriptive statistics and benchmarking will be provided once yearly. A comprehensive multivariate analysis of complex associations between predictors and health-related outcomes will be completed. Statistical analyses will be performed by specialists in each field and will be supervised by public health scientists. To guarantee meaningful analyses, the last patients will be included in December 2013.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1152

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

  • Switzerland
      • St. Gallen, Switzerland, 9006
        • Ostschweizer Kinderspital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Overweight children < 18 years of age

Description

Inclusion Criteria:

  • 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,

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body mass index - standard deviation score (*SDS*), (*BMI-SDS*)
Time Frame: 2 years
Age- and sex-adjusted BMI according to World Health Organisation (*WHO*) charts used in Switzerland
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life as assessed by Quality of life questionnaires for children and adolescents (*KIDSSCREEN*) with 52 questions
Time Frame: 2 years
Outcome Measure is a Scale
2 years
Eurofit - Test
Time Frame: 2 years
Outcome measure is a score on physical fitness and sport activity of children and adolescents
2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ostschweizer Kinderspital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
Federal Office of Public Health, Switzerland
akj, Fachverband Adipositas im Kindes- und Jugendalter, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dagmar lAllemand, Pr, Ostschweizer Kinderspital, St. Gallen, Switzerland

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EKSG 08/023
  • 09.004211/204.0001/-629 (Other Grant/Funding Number: FOPH, CH (www.aramis.admin.ch))
  • l'Allemand, 20110901 (Other Grant/Funding Number: Wyeth Stiftung, Zug)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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