Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000461392p
Ethics application status
Submitted, not yet approved
Date submitted
11/02/2017
Date registered
30/03/2017
Date last updated
30/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutrition Intervention In Metabolic Syndrome In Young People With Mental Illness (NIMSMI)
Scientific title
Prevention and Early Intervention for the Reduction of Risk Factors for Metabolic Syndrome in Young People with Severe Mental Illness: Health & Nutrition Education Approach
Secondary ID [1] 291071 0
None
Universal Trial Number (UTN)
U1111-1192-4827
Trial acronym
NIMSMI
Linked study record
There is no parent study.

Health condition
Health condition(s) or problem(s) studied:
schizophrenia, 301870 0
Bipolar Disorder
 301871 0
Major Depression 302066 0
Obesity 302067 0
Metabolic Syndrome 302068 0
Condition category
Condition code
Mental Health 301550 301550 0 0
Schizophrenia
Metabolic and Endocrine 301552 301552 0 0
Diabetes
Diet and Nutrition 301555 301555 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered by the clinical dietitian who is a higher degree research student with the UNSW. This dietitian provides services to people with mental illness for the past 18 years. Her dietetics experience is of more than 30 years in clinical dietetics in Australia.
a) For all participants, controls and intervention, there will be an initial individual nutritional assessment with 5 monthly follow ups/reviews (individual reviews). This is a face-to-face consultation. Initial individual consultation will last an hour and reviews from 45 minutes to an hour according to individual needs.
b) For the randomly allocated participant to the intervention group (50%), in addition, there will be a weekly nutrition and health education session for 6 months. Each session will last an hour taking into consideration the shortness of concentration of most people with mental illness.
This program will use power point presentations, video forums, cooking demonstrations, eating out and other activities associated with their regular mental health management and activities.
PROGRAM FOR THE INTERVENTION GROUP
Prevention of Metabolic Syndrome in Young People with Severe Mental Illness: A Nutrition Education & Health Promotion Approach - WSLHD-MENTAL HEALTH – PEIRS, BEAT & headspace - THE UNSW - SCHOOL OF PSYCHIATRY - 2017 – 2018
GROUP NUTRITION EDUCATION & HEALTH PROMOTION PROGRAMME INTERVENTION
VENUE: PEIRS & headspace Parramatta [ ] BEAT & headspace Mt Druitt [ ]
MONTH 1
Good Eating For Healthy Young People - to reduce major risks for metabolic syndrome.
Applying the Australian Dietary Guidelines for Healthy Eating
Video
1 Recipe development: snacks
Health Promotion
Art Therapy Evaluation

MONTH 2
Guideline 1 To achieve and maintain a healthy weight
Energy input vs Energy Expenditure
Video
2 Recipe development: meats and fish
Health Promotion
Art Therapy Evaluation

MONTH 3
Guideline 2 Enjoy a wide variety of nutritious foods
Protecting our Heart and Blood Circulation
Video
3 Recipe development: eggs
Health Promotion
Art Therapy Evaluation
MONTH 4
Guideline 3 Limit intake of foods containing saturated fat, added salt, added sugars and alcohol.
Reducing risk of Cancer with good food.
Video
4 Recipe development: fruits and drinks
Health Promotion
Art Therapy Evaluation

MONTH 5
Guideline 4 Encourage, support and promote breastfeeding.
Strong Immune System
Guideline 5 Care for your food; prepare and store it safely
Healthy Bones
Video
5 Recipe development: salads
Health Promotion
Art Therapy Evaluation
MONTH 6
Metabolic Syndrome
Diabetes
Weight – Waist C.
Video

6 Recipe development: desserts
Health Promotion
Art Therapy Evaluation

All the participants, controls and intervention, will have an hour initial full nutritional assessment including and complemented with the following (baseline to be measured against results at 6 and 12 months from intervention):
Clinical Variable & Method of Assessment
Anthropometry : At initial consultation the Dietitian will measure anthropometry: weight, height and waist circumference.
Biochemical markers: Full Blood Count, Lipid Profile, Fasting Glucose, Insulin Level, and HbA1c when diabetes is present.
Clinical database maintained at Blacktown-Mental Health, PEIRS and headspace will be used.
These results will be collected on the Dietitian’s Referral Form.
Physical activity levels Simple Physical Activity Questionnaire (SIMPAQ; (Rosenbaum et al., 2011) and to be applied by the dietitian at first consultation (part of the baseline).
Dietary habits Diet history obtained during first clinical consultation. Food Frequency Questionnaire developed by Gladys Hitchen
The University New Castle Food Frequency Questionnaire
Sleeping patterns-Number of hours of sleep and its pattern, and if food is eaten late at night. Sleep Quality Assessment (PSQI): validated
Nutritional supplementation-If has been prescribed, what was the reason and which supplements are being taken.

Why: to establish a baseline for comparison with results at 6 and 12 months from intervention.
When: to start recruiting in March 2017 (this date needs to be changed as this application is still not approved) as soon as WSLHD-Ethics Committee and the ANZCTR Registry approve my study.
How this will occur: Liaison with the Principal and Associated Investigators have taken place and all are ready to recruit as soon as Ethics and ANZ Registry’s approval is granted. The WSLHD- Referral form for Dietetics in Mental Health will be used for the psychiatrists, nursing and allied health professionals to refer their patients to the study. The computerised randomisation will be the responsibility of the UNSW.
The support of their parents and/or carers have been taken into account, and at the moment of recruitment using a health care professional’s referral, this option will be proposed to the parent or guardian, however is not compulsory as some parents work and would not be able to attend.
The participants are young people with mental illness whose parents and or carers are involved in the clinical care of their children, is part of the patient’s good clinical care practice. It means that the learning during the individual or group education sessions will have a greater chance of being supported at home. What it is important with this option is the possibility of enhancing the health and lifestyle outcomes for the young person when a close relative or guardian is present.

Both groups will receive the individual assessment and follow up, however the intervention group will be allocated to additional learning program as it was explained before.
The monthly reviews or follow up will have a duration of 45 minutes, however, if there is a need for more time, this will be extended to an hour.
Intervention code [1] 297066 0
Prevention
Intervention code [2] 297067 0
Lifestyle
Intervention code [3] 297068 0
Behaviour
Comparator / control treatment
Both, control and intervention participants:
1. At the first session with the clinical dietitian, all referred participants will have a nutritional assessment followed by a dietetic counselling within an hour consultation.
2. All the participants will receive a monthly review session for a period of 5 months. Each review will be for a minimal of 45 minutes and a maximum of 1 hour.
3. All participants will receive an exercise book in which the dietitian will write the main issues addressed at the session. The book will be a tool to facilitate easy reading-reminders of the main messages about the individual session. Also, it will help the participants to write any concerns such as difficulties for making eating habits changes, new food purchasing, cooking barriers and any consultation that the participant and his/her parent or carer will need, when attending the next session.
Control group
Active

Outcomes
Primary outcome [1] 300964 0
1) Anthropometrical data (weight. height, Body Mass Index (BMI) and waist circumference). To be collected by the Dietitian at initial individual consultation (both controls and intervention).
These measurements mean "anthropometrical outcomes", hence includes BMI (height and weight) and waist circumference. Therefore it becomes a "single" outcome as "anthropometry"
Timepoint [1] 300964 0
1) Measurement at baseline. Then at 6 months and finally at 12 months for comparison with baseline.
Primary outcome [2] 300965 0
2) Physical activity using the brief SIMPAQ questionnaire. The dietitian will verbally gather the information from the participants during the first individual session.
It will be assessed by using the same questionnaire SIMPAQ.
Timepoint [2] 300965 0
2) To be measured by the dietitian at baseline, and at 6 months and finally at 12 month. The last 2 measurements will be compared to the baseline.
Primary outcome [3] 301098 0
3) Eating habits. This information will also be gathered during dietitian's first session with all participants. The questionnaire What Did I Eat Yesterday will be used.
The same questionnaire : The questionnaire "What Did I Eat Yesterday" will be used and it will be applied at baseline, at 6 and 12 months.
Timepoint [3] 301098 0
3) Measured at baseline, then at 6 months and finally at 12 months. Last 2 measurements to be compared with baseline data.
Secondary outcome [1] 331282 0
Measurement of sleep pattern. The Pittsburgh Sleep Quality Index (PSQI) will be used.
Timepoint [1] 331282 0
Measured at baseline, then at 6 and 12 months. The last 2 measurement to be compared with baseline as per previous measurements.
Secondary outcome [2] 331725 0
Measurement of smoking will be collected in an Excel spreadsheet (simple page including smoking status) as part of the baseline data collection from all participants:
Do you smoke? Yes [ ]
No [ ]
This is part of a lifestyle measurement.
Timepoint [2] 331725 0
Measured at baseline, then at 6 and 12 months. The last 2 measurement to be compared with baseline as per previous measurements recorded in the excel sheet.
Secondary outcome [3] 332899 0
Measurement of alcohol will be collected in an Excel spreadsheet (simple page including alcohol status) as part of the baseline data collection from all participants.
Do you drink alcohol? Yes [ ]
No [ ]
This is parte of a lifestyle measurement.
Timepoint [3] 332899 0
Measured at baseline, then at 6 and 12 months. The last 2 measurement to be compared with baseline as per previous measurements recorded in the excel sheet.

Eligibility
Key inclusion criteria
Males and females between 12 and 25 years of age diagnosed with schizophrenia, bipolar disorder and/or major depression will be recruited by referral using the Western Sydney Local Health District-Mental Health (WSLHD-MH) dietetics referral form. This will be stated in the Eligibility Form to be used by the medical, nursing and/or allied health professionals working in the WSLHD-Mental Health and/or headspace Parramatta and Mt Druitt.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants diagnosed with mental health conditions other than schizophrenia, bipolar disorder or major depression.
Young people younger than 12 years of age or older than 25 years of age.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed" .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
The dietitian will provide dietetic intervention according to their allocation and will hence be aware of the randomisation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat analyses with linear regression to examine possible trends in BMI over time. Statistical significance of change over time will be evaluated for all variables included in baseline measurements at 12 months.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/04/2017
Actual
Date of last participant enrolment
Anticipated
26/05/2017
Actual
Date of last data collection
Anticipated
25/05/2018
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15269 0
2150 - Parramatta
Recruitment postcode(s) [2] 15271 0
2148 - Blacktown
Recruitment postcode(s) [3] 15272 0
2145 - Westmead
Recruitment postcode(s) [4] 15273 0
2770 - Mount Druitt

Funding & Sponsors
Funding source category [1] 295626 0
Government body
Name [1] 295626 0
Western Sydney Local Health District (WSLHD) Mental Health
Country [1] 295626 0
Australia
Funding source category [2] 295627 0
Other
Name [2] 295627 0
headspace Parramatta
Country [2] 295627 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
BEAT Blacktown
63 Railway Street Mount Druitt NSW 2770
Country
Australia
Secondary sponsor category [1] 294469 0
Other
Name [1] 294469 0
headspace Mt Druitt
Address [1] 294469 0
headspace Mt Druitt
Daniel Thomas Plaza, 12/6-10 Mount St, Mount Druitt NSW 2770
Country [1] 294469 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296838 0
WSLHD Human Research Ethics Committee
Ethics committee address [1] 296838 0
Westmead Hospital, Cnr Hawkesbury & Darcy Rds, Westmead NSW 2145
Ethics committee country [1] 296838 0
Australia
Date submitted for ethics approval [1] 296838 0
15/02/2017
Approval date [1] 296838 0
Ethics approval number [1] 296838 0

Summary
Brief summary
This study aims to contribute to the improvement of the general health of young people affected by schizophrenia, bipolar disease and/or major depression. This model of nutrition and health education is likely to influence the high risk of comorbidities that are known to be related to treatment with the newest psychotropic medications in severe mental illness. Obesity is the key risk factor predisposing to the development of metabolic syndrome, exacerbated by the lack of physical activity seen with these patients. The prevention of the development of obesity among these young people is paramount in order to enhance their physical and mental well being. Educating in isolation is not sufficient to alter outcomes in these patients who require additional support. Family or carers, hence, are key players in the education of their young relatives or clients.

This study aims to establish firm strategies for motivating young people to change their lifestyle by empowering them with knowledge and realistic skills to put into practice for the benefit of their physical and mental health. It is hoped that this can be achieved via the development of health literacy and nutrition education programs which are not only low cost but highly effective.
Trial website
N/A
Trial related presentations / publications
None to date.
Public notes

Contacts
Principal investigator
Name 72186 0
A/Prof Anthony Harris
Address 72186 0
Associate Professor of Psychiatry, Westmead Clinical School
Clinical Director, Brain Dynamics Centre, The Westmead Institute
NSW 2145
Country 72186 0
Australia
Phone 72186 0
+612 9845 6688
Fax 72186 0
+61 2 9635 7734
Email 72186 0
[email protected]
Contact person for public queries
Name 72187 0
A/Prof Philip Ward
Address 72187 0
Philip B. Ward, BMedSc, PhD
Associate Professor and Postgraduate Research Coordinator, School of Psychiatry, UNSW
Director, Schizophrenia Research Unit, South Western Sydney Local Health District
Liverpool Mental Health Centre, Liverpool Hospital.
Locked Bag 7103, Liverpool BC 1871 NSW Australia
Country 72187 0
Australia
Phone 72187 0
+612 9616 4308
Fax 72187 0
+612 9602-5917
Email 72187 0
[email protected]
Contact person for scientific queries
Name 72188 0
A/Prof Philip Ward
Address 72188 0
Philip B. Ward, BMedSc, PhD
Associate Professor and Postgraduate Research Coordinator, School of Psychiatry, UNSW
Director, Schizophrenia Research Unit, South Western Sydney Local Health District
Liverpool Mental Health Centre, Liverpool Hospital.
Locked Bag 7103, Liverpool BC 1871 NSW Australia
Country 72188 0
Australia
Phone 72188 0
+612 9616-4308
Fax 72188 0
+612 9602-5917
Email 72188 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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