Childhood Obesity, Lifestyle Interventions and Psychosocial Well-being

NCT06555380 | Completed

• 1 other identifier: 3518
• Study Type: observational
• Target: 319
• 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. 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.

Conditions

Pediatric Obesity; Psychosocial Well-being

Keywords

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 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 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.

  Annually from August 1st, 2014, to February 1st, 2023)

Study Arms (3)

The one-year intervention group

Children aged 5-10 with obesity who participated in the one-year multifactorial family-centered lifestyle intervention.

Behavioral: The one-year intervention

The three-year intervention group

Children aged 5-10 with obesity who participated in the three-year multifactorial family-centered lifestyle intervention.

Behavioral: The three-year intervention

The non-intervention group

Children with obesity living in one of the municipalities who were never invited to participate in the interventions.

Interventions

The one-year 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.

The one-year intervention group

The three-year intervention BEHAVIORAL

A multifactorial family-centered lifestyle intervention extending up to three years, with clinical visits at local healthcare centers which included repeatedly visits (up to 8 times / year). The intervention was managed by specialized nurses.

The three-year 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 two municipalities in Denmark between August 1st, 2014, and June 30th, 2020. The children have either received treatment with one of the multifactorial family-centered lifestyle interventions or where never invited into the interventions.

You may qualify if:

• 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.

You may not qualify if:

• Children declining participation in a community-based lifestyle intervention.

Sponsors & Collaborators

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

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

DK (1)