Improving physical health and lifestyle in patients with severe mental illness using an eHealth intervention
Improving Physical Health and Lifestyle Behaviors in Patients With Serious Mental Illness: a Cluster Randomized Controlled Trial on the Effectiveness of the Nurse-led GILL eHealth Intervention
This study is testing whether a nurse-led eHealth program can help adults with severe mental illness improve their physical health and lifestyle compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (The Hague, South Holland) |
| Trial ID | NCT05533749 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the GILL eHealth intervention, which is nurse-led, in enhancing physical health and lifestyle behaviors among patients with severe mental illness. It involves a cluster randomized controlled trial comparing the GILL intervention to usual care. The intervention includes somatic screening and lifestyle promotion, resulting in personalized treatment and lifestyle plans for participants. A total of 258 adult patients with a body mass index of 27 or higher will be included, and trained mental health nurses will guide the patients throughout the process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with severe mental illness and a body mass index of 27 or higher who can access and use the internet.
Not a fit: Patients experiencing acute psychiatric crises, severe somatic diseases, or cognitive impairments that hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical health and lifestyle behaviors of patients with severe mental illness.
How similar studies have performed: Other studies have shown promise in using eHealth interventions for improving health outcomes in similar populations, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the criteria of severe mental illness * Aged from 18 to 65 years * Body mass index (BMI) ≥ 27 * Access and ability to use internet * Able and willing to sign informed consent Exclusion Criteria: * Contra-indications (to be assessed by the treating physician/psychiatrist) for participation due to acute psychiatric crisis or severe somatic diseases * Subjects with a cognitive impairment sufficient to interfere with their ability to provide informed consent, complete study questionnaires, or participate in the intervention * Pregnant or breastfeeding women at the time of inclusion * Subject not able to communicate in the Dutch language
Where this trial is running
The Hague, South Holland
- Parnassia Groep — The Hague, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Meike M Hoogervorst
- Email: m.m.hoogervorst@amsterdamumc.nl
- Phone: +31629680823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.