Childhood Obesity, Lifestyle Interventions and Psychosocial Well-being
NCT Number: NCT06555380
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pediatric Obesity|Psychosocial Well-being
Interventions: BEHAVIORAL: The one-year intervention|BEHAVIORAL: The three-year intervention
Sponsor: University of Aarhus
Collaborators: Aarhus Municipality|Randers Municipality, Denmark
Sex: ALL
Age: CHILD
Enrollment: 319
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-06-01
Locations: Steno Diabetes Center Aarhus, Aarhus N, 8200, Denmark

Summary:
Childhood obesity has been associated with an increased risk of impaired psychosocial well-being and the development of depression and anxiety.

This study includes approximately 200 children with obesity aged 5-10 treated within one of two multifactorial family-centered lifestyle intervention in the time-period 2014-2020. Additionally, this study includes 150 children with obesity in the same age group, who were never invited into the multifactorial family-centered lifestyle interventions. During that period the children annually completed the Danish Nation Well-being Questionnaire (DNWQ) in school. The DNWQ is a national questionnaire used to examine the well-being and learning environment in Danish schoolchildren.

The aim is to investigate the long-term impact on psychosocial well-being in children with obesity following participation in one of two multifactorial family-centered lifestyle interventions: a one-year and three-year intervention. Further, to compare this alteration in psychosocial well-being between the intervention groups and with a reference group of children who were never invited to participate in the interventions.

The study will combine data from mandatory health check-ups at school, the Danish National Registries, and the Danish agency for IT and Learning (STIL), The ministry of Education.

Primary Outcome Measures: Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education., The impact on psychosocial well-being will be assessed with responses to specific questions regarding psychosocial well-being related to school from the DNWQ at time of inclusion and at follow-up.

The DNWQ is a national questionnaire completed annually in primary school and used to examine how primary schoolchildren perceive their well-being and learning environment in school.

The following four questions have been selected as our primary outcomes.

1. Question:

   Are you happy with your school?
2. Questions:

   Do you feel lonely at school? (0-3 grade) Do you feel lonely? (4-9 grade)
3. Question:

   Is anyone teasing you so that you feel sad? (0-3 grade) Have you been bullied this school year? (4-9 grade)
4. Question:

Does your stomach ache when you are at school? (0-3 grade) How often does your stomach ache? (4-9 grade), Annually from August 1st, 2014, to February 1st, 2023)
Secondary Outcome Measures: Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education., Same as primary outcome measure, but with other questions chosen from the DNWQ.

The following three questions has been selected as our secondary outcome.

A. Question:

Are you good at solving your problems? (0-3 grade) How often can you find a solution to problems, just by trying hard enough? (4-9 grade)

B. Question:

Can you concentrate during class?

C. Question:

Are you good at helping each other in class? (0-3 grade) Most students in my class are friendly and helpful. (4-9 grade), Annually from August 1st, 2014, to February 1st, 2023)