Childhood Obesity, Decided Not to Participate, Lifestyle Intervention and Psychosocial Well-being.

NCT06705231 | Completed

• 1 other identifier: 3662
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood obesity has been associated with an increased risk of impaired psychosocial well-being and the development of depression and anxiety. However, little is known about the long-term psychosocial impact on children with obesity who decided not to participate in lifestyle interventions, representing a critical gap in literature. This study includes approximately 400 children with obesity aged 5-10 years living in Aarhus municipality in the time-period 2014-2020, who either decided not to participate in a lifestyle intervention, were not invited to participate or attended the intervention. During that period the children annually completed the Danish National 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 of this study is to investigate the long-term impact on psychosocial well-being for children with obesity deciding not to participate in a family-centered lifestyle intervention compared to children who attended the intervention, and to children never invited to participate in the intervention. 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.

Conditions

Pediatric Obesity; Psychosocial Well-being

Keywords

Decided not to Participate; Lifestyle Intervention; Pediatric Obesity; Psychosocial Well-being; Long-term impact

Outcome Measures

Primary Outcomes (1)

• 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 items regarding psychosocial well-being related to school from the DNWQ at time of inclusion and at follow-up. At follow-up, we will prioritize completed questionnaires closest to two years from time of inclusion visit. 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 psychosocial well-being items have been selected: 1. Question: Are you happy with your school? 2. Questions: Do you feel lonely at school? 3. Question: Have you been bullied this school year? 4. Question: Does your stomach ache when you are at school? 5. Question: Are you good at solving your problems? 6. Question: Can you concentrate during class? 7. Question: Are you good at helping each other in class?

  Time Frame: Annually from August 1st, 2014, to February 1st, 2023

Study Arms (3)

Decided not participate group

Children aged 5-10 years with obesity from the city of Aarhus, who decided not to participate in the lifestyle intervention in Aarhus municipality.

Behavioral: The Aarhus-intervention

Intervention group

Children aged 5-10 years with obesity who participated in a one-year lifestyle intervention in Aarhus municipality.

Behavioral: The Aarhus-intervention

Non-intervention group

Children aged 5-10 years with obesity from the city of Aarhus, who were never invited to participate in the intervention.

Interventions

The Aarhus-intervention BEHAVIORAL

A multifactorial family-centered lifestyle intervention with a maximum duration of one year, corresponding to three-four visits. Participants were offered complimentary weekly supervised physical activity. The day-to-day intervention was managed by specialized nurses at local healthcare centers, at the participants' homes, or in a local clinic.

Decided not participate group; Intervention group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with obesity, 5-10 years of age living in Aarhus municipality between August 1st, 2014, and June 30th, 2020. The children have either received treatment with a one-year multifactorial family-centered lifestyle intervention, decided not to participate in the intervention or where never invited to participate in the intervention.

You may qualify if:

• Obesity at time of referral as defined by the IOTF guideline as an iso-BMI \>= 30 kg/m2 adjusted for age and sex.

You may not qualify if:

• Children first decided not to participate, but subsequently accepting the intervention.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus Municipality, Denmark: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus

Arhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

DK (1)