The Halland Obesity Municipal Effort for Children

Hypertension Clinical Trial

Official title:

The Halland Obesity Municipal Effort for Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254938
• Other study ID #: 4294300
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Göteborg University
• Contact: Lovisa Sjögren, MD,PhD
• Phone: 0707144749
• Email: lovisa.sjogren[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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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Related Conditions & MeSH terms

• BMI
• Childhood Obesity
• Hypertension
• Neurodevelopmental Disorders
• Obesity
• Pediatric Obesity
• Physical Activity
• Physical Inactivity

Intervention

Behavioral:
• The Halland Obesity Municipal Effort for children
A comprehensive, intensive lifestyle intervention for the children with the greatest need of intensive treatment.

Locations

Country	Name	City	State
Sweden	Lovisa Sjögren	Särö

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Region Halland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 years completed education	Registry data regarding completion of 12 school years, will be assessed for each patients at the age of 19.	At the age of 19.
Primary	Change from baseline in BMI after 6 month	BMI (weight/height^2), obtained from health records at interventions start and after 6 months of intervention.	Baseline and month 6.
Primary	Change from baseline in BMI after 12 month	BMI (weight/height^2), obtained from health records at interventions start and after one year of intervention.	Baseline and month 12.
Primary	Change from baseline in BMI after 18 months	BMI (weight/height^2), obtained from health records at interventions start and after 18 months of intervention.	Baseline and month 18.
Primary	Change from baseline in gucose homeostasis	Blood samples concerning blood sugar levels (HbA1c, fasting glucose, insulin). Obtained from health records at interventions start and after one year of intervention.	Baseline and month 12.
Primary	Change from baseline in blood pressure	Blood pressure (mm/Hg) measured in right arm sitting down after 5 minutes of rest. Obtained from health records at interventions start and after one year of intervention.	Baseline and month 12.