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Physical HealthNCT06996899

Physical Health Improvement Intervention for People Admitted to Mental Health Service

A study testing Health Improvement Profile (HIP) and Clinician Health Improvement Profile user training in people with Physical Health and Mental Illnesses, run by Charles Darwin University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Health Improvement Profile (HIP) and Clinician Health Improvement Profile user training
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
Jul 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 14Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Brona Nic Giolla Easpaig contact

61 1800061963

b.nicgiollaeaspaig@cdu.edu.au

About this study

Official title: Establishing Utility of a Physical Health Improvement Intervention in a Regional Mental Health Impatient Service: a Multimethod Study

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.

Read the detailed description

People in regional areas with mental illness suffer high prevalence of preventable chronic health conditions. Multi-morbidity in people with mental illness contributes to a reduced life expectancy of up to 20 years. Many physical diseases are preventable and/or reversable if risk factors are identified early, and the right health promotion tools and interventions are provided. Addressing such a complex issue for people with mental illness requires an approach which is adaptable, has been co-designed with clinicians and consumers and is comprehensive to target individualised health behaviours.

This research uses the Health Improvement Profile (HIP) tool to help clinicians (e.g. nurses, doctors) to assess patients physical health and identify risk factors or early signs of chronic disease. Using the Health Improvement Profile (HIP) tool during admission the clinicians will work with clients to implement the most suitable health promotion tools to help improve physical health.

Using implementation research methodology and following the Consolidated Framework for Implementation Research (CFIR) the study is broken into the following 4 stages:

  • Identify
  • Adapt - codesign/adapt Health Improvement Profile (HIP) intervention and develop user training
  • Implement - into clinical areas to assist developing personalised Health Improvement Profile (HIP)
  • Evaluate - using both qualitative and quantitative data to determine feasibility of the Health Improvement Profile (HIP) and implementation in a regional health service
Being tested
Health Improvement Profile (HIP), Clinician Health Improvement Profile user training
Keywords
Implementation Research, Health Improvement Profile
Medical subject headings
Mental Disorders, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Improvement Profile (HIP)Other

    Also called Screening tool, motivational interviewing, behaviour change tool

    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.

  • Clinician Health Improvement Profile user trainingOther

    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.

Study groups in NCT06996899
Study groupRoleWhat they receive
Clinician/Staff users of the Health Improvement ProfileExperimentalExperimental: 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.
Receives: Other: Clinician Health Improvement Profile user training
Experimental: Client receiving the Health Improvement ProfileExperimentalExperimental: 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.
Receives: Other: Health Improvement Profile (HIP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Feasibility: Time taken to recruit planned sample

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

    Measured: Immediately after the inclusion of the last participant

  3. Feasibility: Retention

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

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

  4. Feasibility: Drop out rate

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

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

  5. Reason for dropping out

    Feedback from participant to identify reason for dropping out

    Measured: immediately on drop out notification or at 3 month follow up

  6. 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.

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

  7. 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.

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

Secondary outcomes (28)
  1. Clinician Confidence

    Participant qualitative feedback using open ended questions on confidence for clinicians undertaking the physical assessments and developing care plans

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

  2. Client wellbeing

    Participant qualitative feedback using open ended questions via interview or focus group, on self general overall self reported wellbeing physically and mentally (no quantitative scale to be used), this is qualitative feedback on client wellbeing participating in the HIP project.

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

  3. Biometric measure: Body Mass Index (BMI)

    BMI (kg/m2) is calculated by dividing a person weight in kilograms by the square of their height in metres Outside of normal parameters (red flagged) Underweight <18.50 Overweight ≥25.00

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

  4. Biometric measure: Waist circumference

    Measured in centimetres (cm) - measured by applying the tap measure midway between the top of the hip bone and bottom of ribs, in line with the belly button, wrap measuring tap around your waist.

    Outside of normal measure (red flagged) Female >80cm Male >94cm

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

  5. Biometric measure: Pulse

    Beats per minute (BPM) Outside of normal parameters (red flagged) <60bpm/>100bpm

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

  6. Biometric measure: Blood pressure

    Outside of normal parameters (red flagged) ≥140/90 millimeters of mercury (mm Hg)

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

  7. Biometric measure: Temperature

    Outside of normal parameters (red flagged) <36°Celcius >37.5°Celcius

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

  8. Biometric measure: Liver Function Test

    Outside of normal parameters (red flagged) Liver function test (LFTs) - components.

    • Alanine aminotransferase (ALT) IU/L;

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

  9. Biometric measure: Liver Function Test

    Outside of normal parameters (red flagged) Liver function test (LFTs) - components.

    • Alkaline phosphatase (ALP) IU/L;

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

  10. Biometric measure: Liver Function Test

    Outside of normal parameters (red flagged) Liver function test (LFTs) - components.

    • Gamma- glutamyl transferase (GGT) IU/L;

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

  11. Biometric measure: Liver Function Test

    Outside of normal parameters (red flagged) Liver function test (LFTs) - components.

    • Aspartate aminotransferase (AST) IU/L;

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

  12. Biometric measure: Liver Function Test

    Outside of normal parameters (red flagged) Liver function test (LFTs) - components.

    • Bilirubin mmol/L;

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

  13. Biometric measure: Liver Function Test

    Outside of normal parameters (red flagged) Liver function test (LFTs) - components.

    • Total Protein Prothrombin Time (PT) g/L.

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

  14. Biometric measures: Lipid Levels

    Outside of normal parameters (red flagged) Total Cholesterol ≥6.2mmol/L LDL (bad cholesterol) ≥4.1mmol/L HDL (good cholesterol) <2.1mmol/L Triglycerides ≥2.2mmol/L

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

  15. Biometric measure: Glucose

    Outside of normal parameters (red flagged) <4.0 - >7.0 millimoles of glucose per litre of blood (mmols/L)

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

  16. Biometric measure: Respiratory Rate

    Outside of normal parameters (red flagged) >20 Respiratory rate per minute (rpm)

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

  17. Biometric measure: Sleep

    Outside of normal parameters (red flagged) Self reported: <3hours per night >8hours per night

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

  18. Biometric measure: Smoking

    Outside of normal parameters (red flagged)

    Self reported:

    Smoker - volume per day Passive smoker Non-smoker

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

  19. Biometric measure: Alcohol

    Outside of normal parameters (red flagged) Self reported: >units per day

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

  20. Biometric measure: Fluid intake

    Outside of normal parameters (red flagged) Self reported: <1litre/day >3litres/day

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

  21. Biometric measure: Caffeine intake

    Outside of normal parameters (red flagged) Self reported: ≥600milligrams (mg) /day

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

  22. Biometric Measure: Urine output

    Outside of normal parameters (red flagged) Self reported: <1litre/day >2litres/day

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

  23. Biometric measure: Bowel Function

    Outside of normal parameters (red flagged) Bristol Stool Scale

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

  24. Biometric measure: Reproductive Health

    Outside of normal parameters (red flagged)

    Self reported:

    Sexual Transmitted Infection screening - recent/occasionally/never Female: menstrual cycle Regular 28day ovulation cycle (range:24---35 days) Male: prostate and testicular (self examination) recent/occasionally/never Sexual satisfaction: Satisfied/dissatisfied

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

  25. Biometric measure: Diet

    Outside of normal parameters (red flagged) Intake (serving) per day of protein, fruit, vegetables

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

  26. Biometric measure: Exercise

    Outside of normal parameters (red flagged) Self reported: minutes per day

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

  27. Biometric measure: Eyes

    Outside of normal parameters (red flagged)

    Self reported:

    Concerns/no concerns

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

  28. Biometric measure: Oral Health

    Outside of normal parameters (red flagged)

    Self reported:

    Concerns/no concerns

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06996899
Sponsor's protocol ID
H24039
Status last verified
Mar 2026
First submitted
13 Dec 2024
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Facility request not to share IPD

Publications

  • 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.

    PubMed 32160873
  • 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.

    PubMed 37597457
  • 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.

    PubMed 19538607

Questions about this trial

What is this clinical trial studying?

A study testing Health Improvement Profile (HIP) and Clinician Health Improvement Profile user training in people with Physical Health and Mental Illnesses, run by Charles Darwin University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole Norman (61 1800061963, nicole.norman@cdu.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Health Improvement Profile (time frame: From admission (enrolment) to post discharge period of 3 months (12 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06996899, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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