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NCT06555380Completed

Childhood Obesity, Lifestyle Interventions and Psychosocial Well-being

Impact of Multifactorial Lifestyle Interventions on Psychosocial Well-being for Children Living With Obesity

Source: ClinicalTrials.gov · Last updated 15 Aug 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. 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.

Status (registry)
Completed
Study type
Observational
Enrollment
319 (actual)
First submitted
12 Aug 2024
Start date
Jan 2024
Primary completion date
May 2024
Lead sponsor
University of Aarhus
Diseases
Obesity
NCT number
NCT06555380

What you commit to

  • Study type: Observational
  • Participants enrolled: 319
  • From Jan 2024 to the primary completion date, May 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 declining participation in a community-based lifestyle 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 a BMI \>= 30 kg/m2 adjusted for age and sex.
  • Obesity at time of referral as defined by the IOTF guideline as a BMI \>= 30 kg/m2 adjusted for age and sex.
  • Age between 5 and 10 years at inclusion visit.
  • A completed DNWQ within a timeframe of 10 months prior to 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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Steno Diabetes Center Aarhus
Coordinator of this site? Confirm its status
Aarhus NDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.