Childhood ObesityNCT05254938
The Halland Obesity Municipal Effort for Children
An observational study of Childhood Obesity and Physical Inactivity, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Childhood Obesity, Physical Inactivity, Physical Activity
- What is being tested?
- The Halland Obesity Municipal Effort for children
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 141 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Childhood Obesity, Physical Inactivity, Physical Activity, BMI, Neurodevelopmental Disorders, Hypertension
- Being tested
- The Halland Obesity Municipal Effort for children
- Medical subject headings
- Pediatric Obesity, Sedentary Behavior, Motor Activity, Neurodevelopmental Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Halland Obesity Municipal Effort for childrenBehavioural
A comprehensive, intensive lifestyle intervention for the children with the greatest need of intensive treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
12 years completed education
Registry data regarding completion of 12 school years, will be assessed for each patients at the age of 19.
Measured: At the age of 19.
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.
Measured: Baseline and month 6.
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.
Measured: Baseline and month 12.
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.
Measured: Baseline and month 18.
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.
Measured: Baseline and month 12.
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.
Measured: Baseline and month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Jan 2019
- Primary completion10 Mar 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Halland
- Responsible party
- Sponsor
- Investigators
- Josefine Roswall, MD, PhD, Study chair, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254938
- Sponsor's protocol ID
- 4294300
- Status last verified
- Jun 2025
- First submitted
- 22 Oct 2021
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Halland Obesity Municipal Effort for Children
- ClinicalTrials.gov ID
- NCT05254938
- Acronym / sponsor ID
- 4294300
- Conditions
- Childhood Obesity, Physical Inactivity, Physical Activity, BMI, Neurodevelopmental Disorders, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Region Halland
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Halland Obesity Municipal Effort for childrenA comprehensive, intensive lifestyle intervention for the children with the greatest need of intensive treatment. | Behavioural | – |
Primary outcome
12 years completed education
Time frame: At the age of 19.
Registry data regarding completion of 12 school years, will be assessed for each patients at the age of 19.
Change from baseline in BMI after 6 month
Time frame: Baseline and month 6.
BMI (weight/height^2), obtained from health records at interventions start and after 6 months of intervention.
Change from baseline in BMI after 12 month
Time frame: Baseline and month 12.
BMI (weight/height^2), obtained from health records at interventions start and after one year of intervention.
Change from baseline in BMI after 18 months
Time frame: Baseline and month 18.
BMI (weight/height^2), obtained from health records at interventions start and after 18 months of intervention.
Change from baseline in gucose homeostasis
Time frame: Baseline and month 12.
Blood samples concerning blood sugar levels (HbA1c, fasting glucose, insulin). Obtained from health records at interventions start and after one year of intervention.
Change from baseline in blood pressure
Time frame: Baseline and month 12.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josefine Roswall, MD, PhD study chair
Region Halland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Physical Inactivity, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 years completed education (time frame: At the age of 19.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.