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NCT05533749: GILL
Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness
NA trial testing GILL eHealth in Severe Mental Disorder in 258 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Amsterdam UMC, location VUmc |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 258 |
| Start date | 30 May 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- GILL eHealth
Conditions studied
- Severe Mental Disorder — all drugs for Severe Mental Disorder →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
- Lifestyle — all drugs for Lifestyle →
- Somatic Screening — all drugs for Somatic Screening →
Sponsor
Amsterdam UMC, location VUmc — full company profile →
Who can join
Adults 18 to 65, any sex, with Severe Mental Disorder or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to evaluate the effectiveness of the nurse-led GILL (Gezondheid in Lichaam en Leefstijl) eHealth intervention in patients with serious mental illness (SMI), compared to usual care. Expected is that the GILL eHealth intervention will be more effective than usual care in improving physical health and lifestyle behaviors. To evaluate this, we will perform a cluster randomized controlled trial with an embedded process evaluation of the implementation of the GILL intervention. 258 adult patients with serious mental illness and a body mass index of 27 or higher (overweight/obesity) will be included. The GILL eHealth intervention consists of two complementary modules for (a) somatic screening and (b) lifestyle promotion, resulting in a personalized somatic treatment and lifestyle plan. Trained mental health nurses and clinical nurse specialists will implement the intervention within the multidisciplinary treatment context, and will guide and support the patients in the promotion of their somatic health, including cardiometabolic risk management. The intervention will be compared to usual care, which includes treatment according to national guidelines. The outcome measures will be metabolic syndrome severity (primary), fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, health related self-efficacy and health care utilization after 1 year. The process evaluation focuses on the feasibility of the eHealth intervention, its acceptability for patients and health care providers (mainly mental health nurses and clinical nurse specialists), and barriers/facilitators to implementation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The nurse-led GILL eHealth intervention for improving physical health and lifestyle behaviours in clients with severe mental illness: design of a cluster-randomised controlled trial.
Hoogervorst MM, van Meijel B, Bruin EK, Beekman A, et al · · 2023 · cited 2× · PMID 37715156 · DOI 10.1186/s12888-023-05024-z
Verify or expand the search:
- PubMed search for NCT05533749
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05533749 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amsterdam UMC, location VUmc
- Last refreshed: 14 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05533749.
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