NCT06996899

Brief Summary

This study aims to codesign and implement a physical health improvement behaviour change intervention for people being treated for a mental illness in a mental health inpatient unit of a regional hospital.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
29mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 13, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

December 13, 2024

Last Update Submit

March 17, 2026

Conditions

Keywords

Implementation ResearchHealth Improvement Profile

Outcome Measures

Primary Outcomes (7)

  • Feasibility of Health Improvement Profile

    Each Health Improvement Profile parameter has a column for recording the assessment result, followed by a column indicating the healthy 'green' range or indicating the unhealthy 'red' range (requiring action). The final column indicates the recommended action if the parameter falls into the 'red' range. Baseline assessment, (up to 27 assessment points for males and 26 assessment points for females) using the Health Improvement Profile (HIP) to identify the number of red flags, this is baseline assessment data which falls outside of normal healthy parameters. Baseline assessment will occur at pre intervention (at time of admission to the inpatient unit), during intervention use (at discharge from inpatient facility with a developed Health Improvement Profile) and post intervention (3months post discharge from inpatient facility) to determine physical health improvement against baseline assessment.

    From admission (enrolment) to post discharge period of 3 months (12 weeks)

  • Feasibility: Time taken to recruit planned sample

    The time that was taken to recruit the planned sample size of participants

    Immediately after the inclusion of the last participant

  • Feasibility: Retention

    Proportion of participants who completed the whole study by all participants who enrolled

    at the follow-up assessment 3 months post discharge from inpatient service

  • Feasibility: Drop out rate

    Number of participants who dropped out , did not continue with health improvement profile after discharging from inpatient service

    At the follow-up assessment 3 months post discharge from inpatient service

  • Reason for dropping out

    Feedback from participant to identify reason for dropping out

    immediately on drop out notification or at 3 month follow up

  • Feasibility: Adherence

    Proportion (percentage %) of recommended actions on the Health Improvement Profile (HIP) which the patient self reports as completing up to 3 months post discharge.

    Immediately on completion of the post discharge period at 3 months (12 weeks)

  • Participant feedback

    Participant qualitative feedback using open ended questions on satisfaction with the Health Improvement Profile. Analysed using standardised thematic analysis of the qualitative feedback.

    Immediately after completion of the follow up period of 3 months (12 weeks)

Secondary Outcomes (28)

  • Clinician Confidence

    At completion of training, at the project interim point (3 months) and at end of project.

  • Client wellbeing

    Immediately at completion of the follow up period (3 months)

  • Biometric measure: Body Mass Index (BMI)

    At commencement (admission) to inpatient unit and after completion of follow up period 3 months (12 weeks)

  • Biometric measure: Waist circumference

    At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)

  • Biometric measure: Pulse

    At commencement (admission) to inpatient unit and after completion of follow up period at 3 months (12weeks)

  • +23 more secondary outcomes

Study Arms (2)

Clinician/Staff users of the Health Improvement Profile

EXPERIMENTAL

Experimental: Staff intervention group Participants will receive education and training on how to conduct comprehensive physical assessments for the 27 health parameters on the Health Improvement Profile (HIP) and how to use these assessment finding to determine the recommended actions (behaviours changes) to develop an individualised profile for the admitted patient.

Other: Clinician Health Improvement Profile user training

Experimental: Client receiving the Health Improvement Profile

EXPERIMENTAL

Experimental: Client intervention group Participants will have a comprehensive physical assessment conducted by a trained clinician (health professional in the mental health inpatient service. The assessments consist of 27 health parameters such as weight, Body Mass Index (BMI), blood pressure, blood glucose, cholesterol levels, and waist circumference, alongside questions on lifestyle factors like smoking, diet, and physical activity, as well as medication use and its side effects. Using the assessment data clients will participate in the development of an individualised Health Improvement Plan (HIP) utilising the recommended behaviour change actions.

Other: Health Improvement Profile (HIP)

Interventions

The Health Improvement Profile (HIP) is a comprehensive physical assessment conducted by a trained clinician which aims to link evidence based interventions for flagged abnormal health parameters. There are 27 health parameters assessed such as weight, Body Mass Index (BMI), blood pressure, blood glucose, cholesterol levels, and waist circumference, alongside questions on lifestyle factors like smoking, diet, and physical activity, as well as medication use and its side effects. Client participant will collaborate with their clinician in developing an individualised Health Improvement Profile which identifies suitable health behaviours interventions to improve physical health. Health behaviours may be associated with diet, exercise, sleep, hygiene (including oral care) and mindfulness.

Also known as: Screening tool, motivational interviewing, behaviour change tool
Experimental: Client receiving the Health Improvement Profile

Clinician/staff participants will receive Health Improvement Profile user training on how to conduct the comprehensive physical assessments for 27 health parameters and how to link the evidence based actions to develop an individualised Health Improvement Profile for clients admitted to inpatient service. Training includes online videos simulating assessments and completing the Health Improvement Profile and face to face workshops.

Clinician/Staff users of the Health Improvement Profile

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • This study is being carried out in an inpatient service therefore clinical staff must be registered by their professional governing body with a minimum of 6 months employment at the service or within the region to participate in stages 2 and 3. Graduate clinicians with less than 6 months working experience will be excluded from the study. Clinicians new to the region with less than 6 months working experience in location will be excluded from the study. Clinical roles within the facility include but not limited to:
  • Nurses (enrolled or registered)
  • Psychiatrists
  • Psychologists
  • Social Workers
  • Clients of the inpatient mental health service eligible to be included in the study must be:
  • Over the age of 18 years
  • Able to read, understand and speak English
  • A current or previous user of the hospital's services
  • A current or previous user of the inpatient services
  • A carer of someone who is a current or previous user of the inpatient mental health service
  • Able to provide consent
  • Not an employee
  • Not a health professional

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Werkkala C, Valimaki M, Anttila M, Pekurinen V, Bressington D. Validation of the Finnish Health Improvement Profile (HIP) with patients with severe mental illness. BMC Psychiatry. 2020 Mar 11;20(1):112. doi: 10.1186/s12888-020-02511-5.

    PMID: 32160873BACKGROUND
  • Meepring S, Gray R, Li X, Chien WT, Li Y, Ho GWK, Kritkitrat P, Bressington D. Evaluating the efficacy of the Thai Health Improvement Profile intervention for preventing weight gain in people with early stage psychosis: A randomized controlled trial. Int J Nurs Stud. 2023 Oct;146:104570. doi: 10.1016/j.ijnurstu.2023.104570. Epub 2023 Jul 31.

    PMID: 37597457BACKGROUND
  • White J, Gray R, Jones M. The development of the serious mental illness physical Health Improvement Profile. J Psychiatr Ment Health Nurs. 2009 Jun;16(5):493-8. doi: 10.1111/j.1365-2850.2009.01375.x. Epub 2008 Mar 9.

    PMID: 19538607BACKGROUND

MeSH Terms

Conditions

Mental DisordersChronic Disease

Interventions

Potentially Inappropriate Medication ListMotivational Interviewing

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The one group is all adults admitted to the inpatient mental health service . The parallel group is the clinicians/staff working in the patient mental health service.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator (PhD Candidate), Registered Nurse

Study Record Dates

First Submitted

December 13, 2024

First Posted

May 30, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Facility request not to share IPD