HRQoL in Overweight and Obese Children/Adolescents

NCT ID: NCT05424094

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-09-30

Brief Summary

The primary aim of the present study is to record changes in the health-related quality of life (HRQoL) of children/adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. In addition, these data will be examined for correlation with changes in BMI, waist and hip circumference, and motor performance.

Secondarily, the study addresses the questions of whether the recording of HROoL by means of the KINDL questionnaire is practicable for the programme leaders and what benefit can be gained from the analysed data for future cohorts.

Detailed Description

According to the 2021 publication of the WHO European Childhood Obesity Surveillance Initiative (COSI), overweight and obesity in children and adolescents remains one of the most serious health problems facing the European population in the 21st century. The WHO responded to this problem in 2019 with a review paper on the propagated intervention approaches. With its developed national guidelines, Switzerland relies on multiprofessional group programmes. One of the eleven currently tested and certified programmes is 'kinderleicht' in Chur. The nationwide KIDSSTEP study from 2014 - on which the nationwide guidelines for multiprofessional group programmes are based - shows that it is imperative to record the health-related quality of life (HRQoL) of the children and adolescents as well as their families. In practice, however, this evidence is still too little implemented. Using the example of 'kinderleicht', it is to show that the recording and documentation of HRQoL is practicable and can provide valuable insights for both programme participants and programme managers. The primary goal is to record the health-related quality of life of children and adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. At the same time, these data are to be correlated and interpreted with changes in BMI, waist and hip circumference and motor performance. Secondarily, possible sensitive/difficult phases of a participant during the active phase of the intervention will be identified in order to provide the best possible coaching to the families of future cohorts.

Conditions

Obesity, Childhood; Health Related Quality of Life; Intervention Program; Obesity, Adolescent; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

'kinderleicht' programme

Children receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals.

Group Type: EXPERIMENTAL

multi-professional group programme 'kinderleicht'

Intervention Type: BEHAVIORAL

12-16 children/adolescents who participate in the multi-professional group programme 'kinderleicht' receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals on fridays during 11 months.

Interventions

multi-professional group programme 'kinderleicht'

12-16 children/adolescents who participate in the multi-professional group programme 'kinderleicht' receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals on fridays during 11 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. girls/boys aged 7-17 years.

2. participation with children

3. age-adjusted BMI: P > 97th percentile or 90th-97th percentile + diseases whose prognosis is worsened by the overweight or are the result of the overweight

4. medical examination unobjectionable

5. motivation to participate in the programme is given

6. written informed consent of the participant, 6.1. for children up to 14 years of age, verbal consent of the child is sufficient, plus written consent of the parents or a legal representative 6.2. for adolescents aged 14 and over, written consent from the adolescent is sufficient.

Exclusion Criteria

1. BMI < 90 percentile

2. not part of 'easy for children

3. medical examination questionable

4. no motivation to participate in the programme

5. no verbal and/or written consent of the children and their parents/legal representatives

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frank Wieber

OTHER

Sponsor Role: lead

Responsible Party

Frank Wieber

professor doctor Frank Wieber

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

HRQoL_29.12.21

Identifier Type: -

Identifier Source: org_study_id