NCT06705231Completed
Childhood Obesity, Decided Not to Participate, Lifestyle Intervention and Psychosocial Well-being.
Does Deciding Not to Participate in a Lifestyle Intervention Affect the Long-term Change in Psychosocial Well-being for Children With Obesity?
Source: ClinicalTrials.gov · Last updated 26 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 403 (actual)
- First submitted
- 22 Nov 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- University of Aarhus
- Diseases
- Obesity
- NCT number
- NCT06705231
What you commit to
- Study type: Observational
- Participants enrolled: 403
- From 1 Mar 2024 to the primary completion date, 1 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Children first decided not to participate, but subsequently accepting the intervention.
Who the study is looking for
- Inclusion visit between August 1st, 2014, and June 30th, 2020.
- Obesity at time of referral as defined by the IOTF guideline as an iso-BMI \>= 30 kg/m2 adjusted for age and sex.
- Age between 5 and 10 years at inclusion visit.
- A measure of weight and height within 6 months before or after time of inclusion
- A completed DNWQ at inclusion:
- The decided not to participate / non-intervention groups - with a timeframe between 6 months prior to and 6 months after inclusion.
- The intervention group - with a timeframe between 10 months prior to and 2 months after inclusion.
- A completed DNWQ at follow-up (1 to 3 years after inclusion visit).
Age in the registry: 5 years to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Aarhus Coordinator of this site? Confirm its status | Arhus N | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.