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HRQoL in Overweight and Obese Children/Adolescents

Primary Purpose

Obesity, Childhood, Health Related Quality of Life, Intervention Program

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multi-professional group programme 'kinderleicht'
Sponsored by
Frank Wieber
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring obesity, overweight, health related quality of life

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    'kinderleicht' programme

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    health related quality of life (HRQoL) over 11 months
    measured with the 'KINDL'-questionair; linkert scaled with a maximum value of 100 and a minimum value of 0 (points); the higher the score the better

    Secondary Outcome Measures

    Rate of Body Mass Index (BMI) over 11 months
    weight (kilograms) and height (meters) will be combined to report the BMI rate in kg/m^2; the BMI rate is age-appropriate for children and adolescents; the aim of the intervention programme is to reduce the BMI rate in obese children so a lower BMI rate is better than a higher one
    hip-waist ratio
    hip and waist circumference in centimetres are combined to hip-waist ratio
    motor performance
    motor performance ist measured in seven categories by test DKT-Fitnessolympiade; Results are graded according to the German school grading system; minimum grade 6 and maximum grade 1; the lower the grade the better

    Full Information

    First Posted
    November 25, 2021
    Last Updated
    June 15, 2022
    Sponsor
    Frank Wieber
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05424094
    Brief Title
    HRQoL in Overweight and Obese Children/Adolescents
    Official Title
    Health-related Quality of Life in Overweight and Obese Children/Adolescents - a Pilot Project in the 'Kinderleicht' Group Programme
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    January 31, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Frank Wieber

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood, Health Related Quality of Life, Intervention Program, Obesity, Adolescent, Overweight and Obesity
    Keywords
    obesity, overweight, health related quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    'kinderleicht' programme
    Arm Type
    Experimental
    Arm Description
    Children receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals.
    Intervention Type
    Behavioral
    Intervention Name(s)
    multi-professional group programme 'kinderleicht'
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    health related quality of life (HRQoL) over 11 months
    Description
    measured with the 'KINDL'-questionair; linkert scaled with a maximum value of 100 and a minimum value of 0 (points); the higher the score the better
    Time Frame
    11 months
    Secondary Outcome Measure Information:
    Title
    Rate of Body Mass Index (BMI) over 11 months
    Description
    weight (kilograms) and height (meters) will be combined to report the BMI rate in kg/m^2; the BMI rate is age-appropriate for children and adolescents; the aim of the intervention programme is to reduce the BMI rate in obese children so a lower BMI rate is better than a higher one
    Time Frame
    11 months
    Title
    hip-waist ratio
    Description
    hip and waist circumference in centimetres are combined to hip-waist ratio
    Time Frame
    11 months
    Title
    motor performance
    Description
    motor performance ist measured in seven categories by test DKT-Fitnessolympiade; Results are graded according to the German school grading system; minimum grade 6 and maximum grade 1; the lower the grade the better
    Time Frame
    11 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: girls/boys aged 7-17 years. participation with children 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 medical examination unobjectionable motivation to participate in the programme is given 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: BMI < 90 percentile not part of 'easy for children medical examination questionable no motivation to participate in the programme no verbal and/or written consent of the children and their parents/legal representatives

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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