- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05254938
The Halland Obesity Municipal Effort for Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Särö, Sweden, 42943
- Lovisa Sjögren
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Baseline and month 6.
|
|
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.
|
Baseline and month 12.
|
|
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.
|
Baseline and month 18.
|
|
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.
|
Baseline and month 12.
|
|
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.
|
Baseline and month 12.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Josefine Roswall, MD, PhD, Region Halland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4294300
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
Clinical Trials on The Halland Obesity Municipal Effort for children
-
Spineology, IncCompletedLumbar Degenerative Disc DiseaseUnited States
-
Haukeland University HospitalUnknownCushings SyndromeNorway
-
National Taiwan University HospitalEnrolling by invitationPain | Emotions | FearTaiwan
-
Universiti Putra MalaysiaCompletedChildhood Obesity | Life Style Modification
-
Samsung Medical CenterRecruitingCritical IllnessKorea, Republic of
-
Maimónides Biomedical Research Institute of CórdobaHospital Universitario Reina Sofia de Cordoba; Universidad de CórdobaRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingSensorineural Hearing LossFrance
-
Rutgers, The State University of New JerseyUnited States Department of Agriculture (USDA)CompletedCognitive Change | Parent-Child Relations | Parenting | Parents | Child Behavior | Healthy Lifestyle | Home Environment Related Disease | Child ObesityUnited States
-
University of AarhusRanders Municipality, Denmark; Aarhus KommuneCompleted
-
Adina MaeirMonash UniversityRecruitingAttention Deficit Disorder With Hyperactivity (ADHD)Israel