NCT05254938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

October 22, 2021

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Interventions

A comprehensive, intensive lifestyle intervention for the children with the greatest need of intensive treatment.

Eligibility Criteria

Age5 Years - 21 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWe will follow the gender that the patient aknowledges based on regional ethical considerations.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisa Sjögren

Särö, 42943, Sweden

Location

MeSH Terms

Conditions

Pediatric ObesitySedentary BehaviorMotor ActivityNeurodevelopmental DisordersHypertension

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorMental DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Josefine Roswall, MD, PhD

    Region Halland

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 22, 2021

First Posted

February 24, 2022

Study Start

January 1, 2019

Primary Completion

March 10, 2022

Study Completion

December 31, 2024

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations