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POP-Study

Pharmacotherapy in Children and Adolescents with Obesity: Real-World Outcomes - POP-Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58149
Enrollment
220
Registered
2025-08-20
Start date
2025-11-19
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and obesity Overweight and obesity

Interventions

Pharmacotherapy for obesity in standard care.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age =18 years at the start of  pharmacotherapy Documented diagnosis of overweight or obesity in the medical record (BMI-SDS = +1 for age and sex or local definition)One or more anti-obesity medications prescribed and documented in the medical record, including at least one of the following: metformin, liraglutide, semaglutide, or other medication designated as anti-obesity medication by the treating physician. The anti-obesity pharmacotherapy was prescribed during the following period: 1 January 2020 up to and including 1 January 2026. Availability of at least the following data in the medical record: weight and height at baseline and at least one follow-up moment, medication registration, relevant adverse events/incidents. Use of concurrent weight-inducing medication (antidepressants, antiepileptic medication, corticosteroids) is not an issue, however, this subgroup will undergo a separate analysis.  The presence of other diagnoses, such as a syndrome or chronic disease, is not an issue, however, this subgroup will undergo a separate analysis.  

Exclusion criteria

Exclusion criteria: Receive anti-obesity pharmacotherapy (e.g. metformin, liraglutide, semaglutide, tirzepatide, dexamphetamine) for any indication other than obesity (e.g. diabetes mellitus, ADHD). No follow-up data available in the medical record (e.g., referral only without follow-up).Patients whose parents or legal guardians have explicitly objected to participation in scientific research.

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the change in BMI SDS and %BMIp95 over time, as a measure of treatment effectiveness. This will be assessed between the start of pharmacotherapy and follow-up time points (e.g., 4 and 12 months, depending on data availability).

Secondary

MeasureTime frame
Anthropometric changes, like waist circumference and waist-to-height ratio. Safety and tolerability, assessed through the frequency and nature of reported adverse events and treatment discontinuation.Changes in cardiometabolic risk factors (e.g. blood pressure, lipids, liver enzyme, glucose)Changes in quality of life  measured by PedsQL or IWQoL, where available.Changes in eating behavior, measured by Dutch eating behavior questionnaire (DEBQ-C)Predictors of treatment response 

Countries

Netherlands

Contacts

Public ContactE.L.T. Akker

Erasmus MC, Universitair Medisch Centrum Rotterdam

e.l.t.vandenakker@erasmusmc.nl010-704 07 04

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)