Clinical trial NCT05254938: The Halland Obesity Municipal Effort for Children
Official title: The Halland Obesity Municipal Effort for Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Physical Inactivity
Physical Activity
BMI
Neurodevelopmental Disorders
Hypertension
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Region Halland
First posted: 2022-02-24
Enrollment: 141
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 5-21 that were followed at a pediatric clinic for obesity and with complicating factors such as comorbidity, socioeconomic vulnerability, lonliness and problematic school absenteeism.

Brief summary: A retrospective study to investigate the method called The Halland Obesity Municipal Effort for children. All children participating in the intervention since the start of this specific method will be eligible for inclusion. The aims are to describe participants and the method-specific activities they are participating in, as well as the effect on their health and school grades.

Detailed description: This method involves the entire municipal community in Laholm and Kungsbacka (two cities in Sweden): Pediatric care unit, Child Psychiatry, Social services, School healthcare, private companies, and local sports clubs. The model includes group activities and individual activities and offer 15 different health promoting and free activities per week.

All activities are modified and take place in a safe environment. The activities range from golf, riding, gym training, swimming, fishing, art classes, karate, dance classes, and the possibility for the child to get a grade in Physical Education through a specific collaboration with the local schools in the municipality.

The children are given a fruit at each activity and cooking classes are frequently given. The municipal activity coordinator who is responsible uses different methods such as KASAM, Health Action Model and Empowerment to help each child develop skills in self-monitoring, goal setting, problem solving, contingent reward systems, and stimulus control. Parents are given a specific support program called COPE, Community Parent Education. Some activities include the whole family.

In addition to the weekly activities, the activities are also always given on school holidays and weekends when children are known to be less active.

This study will investigate this method by focusing on BMI, metabolic control, blood pressure, level of physical activity, age, sex, the existence of comorbidities, presence of neurodevelopmental disorders, school related issues, involvement of social services, need of grades in Physical Education and help to learn how to swim, which activities the children were undertaking as well as the frequency of participation. The proportion of children achieving full 12 years of education will also be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients involved in the HOME project since the start. Children that have been offered this intense intervention.

Exclusion Criteria: Those who are not willing to participate.

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Primary outcomes:
measure: 12 years completed education
timeFrame: At the age of 19.
measure: Change from baseline in BMI after 6 month
timeFrame: Baseline and month 6.
measure: Change from baseline in BMI after 12 month
timeFrame: Baseline and month 12.
measure: Change from baseline in BMI after 18 months
timeFrame: Baseline and month 18.
measure: Change from baseline in gucose homeostasis
timeFrame: Baseline and month 12.
measure: Change from baseline in blood pressure
timeFrame: Baseline and month 12.
Secondary outcomes:
Other outcomes:
Locations:
city: Särö
country: Sweden
facility: Lovisa Sjögren
Study officials:
affiliation: Region Halland
name: Josefine Roswall, MD, PhD
role: STUDY_CHAIR
References: