Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05533749

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

Led by Amsterdam UMC, location VUmc · Updated on 2024-06-14

258

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Amsterdam UMC, location VUmc

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of the nurse-led GILL eHealth intervention for adults with serious mental illness (SMI) who are overweight or obese, with a body mass index of 27 or higher. This study compares the GILL intervention to usual care in a cluster randomized controlled trial. The goal is to see if the GILL eHealth program can better improve physical health and lifestyle behaviors, focusing on managing cardiometabolic risks among this population. The GILL eHealth intervention includes two parts: OurGILL, which provides systematic somatic screening to detect and manage physical health problems, and MyGILL, which helps create a personalized lifestyle plan. This intervention is delivered through an online platform and a mobile app, guided by trained mental health nurses and clinical nurse specialists within a multidisciplinary care setting. Patients in the control group receive usual care as per national guidelines. Participants will be monitored for one year, with assessments including metabolic syndrome severity, fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, self-efficacy, and healthcare use. Researchers will also evaluate how feasible and acceptable the eHealth intervention is for patients and healthcare providers, identifying any challenges or supports during implementation.

CONDITIONS

Brief Title

Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the criteria of severe mental illness
  • Aged from 18 to 65 years
  • Body mass index (BMI) 27 27
  • Access and ability to use internet
  • Able and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Contra-indications due to acute psychiatric crisis or severe somatic diseases as assessed by treating physician/psychiatrist
  • Cognitive impairment interfering with informed consent, completing questionnaires, or participation
  • Pregnant or breastfeeding women at the time of inclusion
  • Unable to communicate in the Dutch language

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 12 months

Participants perform the GILL eHealth intervention which includes systematic somatic screening and lifestyle behavior support through an individual internet environment and app.

Regular use of the eHealth modules throughout the study period

Long-term Monitoring

Duration - 12 months

Participants are monitored for physical health and lifestyle outcomes over the study duration.

Assessments at baseline and after 12 months

Trial Site Locations

Total: 1 location

1

Parnassia Groep

The Hague, South Holland, Netherlands, 2553 RJ

Actively Recruiting

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Research Team

M

Meike M Hoogervorst

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Meike M Hoogervorst, Berno van Meijel, Esther Krijnen-de Bruin...

https://pubmed.ncbi.nlm.nih.gov/37715156