HRQoL in Overweight and Obese Children/Adolescents

NCT05424094 | Unknown

• 1 other identifier: HRQoL_29.12.21
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

obesity; overweight; health related quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  11 months

Secondary Outcomes (3)

• Rate of Body Mass Index (BMI) over 11 months

  11 months

• hip-waist ratio

  11 months

• motor performance

  11 months

Study Arms (1)

'kinderleicht' programme

EXPERIMENTAL

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

Behavioral: multi-professional group programme 'kinderleicht'

Interventions

multi-professional group programme 'kinderleicht' 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.

'kinderleicht' programme

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank Wieber: lead

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor doctor Frank Wieber

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: June 21, 2022
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: September 30, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share