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Trial registered on ANZCTR


Trial ID
ACTRN12613000572763
Ethics application status
Approved
Date submitted
16/05/2013
Date registered
21/05/2013
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Mediterranean-style diet and fish oil supplementation on mental and cardiometabolic health of Community Rehabilitation Centre residents: a pilot feasibility study
Scientific title
Effects of a Mediterranean-style diet and fish oil supplementation on mental and cardiometabolic health of Community Rehabilitation Centre residents with mental illness: a pilot feasibility study
Secondary ID [1] 282517 0
None
Universal Trial Number (UTN)
Trial acronym
HELFIMED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 289179 0
Cardiometabolic health 289180 0
Condition category
Condition code
Diet and Nutrition 289500 289500 0 0
Other diet and nutrition disorders
Mental Health 289524 289524 0 0
Schizophrenia
Metabolic and Endocrine 289525 289525 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given free fish oil capsules (providing 750mg EPA + DHA/day) for 6 months and weekly free food hampers (containing a weekly supply of extra virgin olive oil, seasonal fruit and vegetables, legumes and nuts) for 3 months. They will take part in 1-hour long weekly cooking workshops over 6 months (currently held twice a week) in basic cooking skills and Mediterranean-style diet and will be encouraged to set goals for healthy eating and cooking each week. Workers will assist them to incorporate recipes provided into their weekly shopping list and cooking as part of their existing rehabilitation program. Adherence will be monitored by staff recording of fish oil capsules, food diaries where possible, and blood samples that will indicate whether levels of omega-3 fatty acids and carotenoids have increased and homocysteine and sodium:potassium ratio have decreased. Fish oil capsules and hampers will all commence at baseline; fish oil will be provided for 6 months and free hampers for 3 months, after which participants will be assisted to purchase required food items as part of their weekly shopping.
Intervention code [1] 287174 0
Lifestyle
Comparator / control treatment
N/a (open label)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289603 0
Kessler Psychological Distress Scale – K10
Timepoint [1] 289603 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Primary outcome [2] 289604 0
LPHoN - Lifeskills Profile and Health of Nations Outcomes Scale
Timepoint [2] 289604 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Primary outcome [3] 289605 0
AQoL-8D - Assessment of Quality of Life
Timepoint [3] 289605 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [1] 302827 0
Self-efficacy questionnaire (regarding cooking and healthy dietary behaviours)
Timepoint [1] 302827 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [2] 302828 0
Body Mass Index (BMI)
Timepoint [2] 302828 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [3] 302829 0
Blood glucose
Timepoint [3] 302829 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [4] 302830 0
Homocysteine (plasma)
Timepoint [4] 302830 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [5] 302831 0
K:Na (Potassium:Sodium) ratio (in urine)
Timepoint [5] 302831 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [6] 302832 0
Carotenoids (blood plasma)
Timepoint [6] 302832 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [7] 302833 0
BDNF (brain-derived neurotrophic factor) in plasma
Timepoint [7] 302833 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)
Secondary outcome [8] 302835 0
Fatty acid profile (in red blood cells) - particularly omega-3 fatty acids
Timepoint [8] 302835 0
Baseline, 3 and 6 months (+ 12 month follow up if possible)
Secondary outcome [9] 302884 0
14-item Mediterranean diet questionnaire
Timepoint [9] 302884 0
Baseline, 3 and 6 months (+ follow up at 12 months if possible)

Eligibility
Key inclusion criteria
Residents of the Community Rehabilitation Care centre (part of a stepped-care system for people with mental illness)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via information sessions at the centre and will provide signed consent to take part.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The project will form part of residents' existing rehabilitation plan. It is a pilot feasibility study - if successful we will apply for funding to do it in multiple centres with staggered starting points.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Within-group t-tests to test differences between baseline and post-intervention. Correlations and multiple regressions to test associations between changes in biomarkers (fatty acids, homocysteine, carotenoids, BDNF, K:Na ratio) and any improved mental/cardiometabolic health outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 6893 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 287299 0
University
Name [1] 287299 0
University of South Australia
Address [1] 287299 0
GPO Box 2471
Adelaide SA 5001
Country [1] 287299 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 286051 0
Other
Name [1] 286051 0
Mental Health Directorate, Southern Adelaide Local Health Network
Address [1] 286051 0
Trevor Parry Centre
9 Grey Box Avenue
Noarlunga Centre SA 5168
Country [1] 286051 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289274 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 289274 0
The Flats G5 – Rooms 3 and 4
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 289274 0
Australia
Date submitted for ethics approval [1] 289274 0
Approval date [1] 289274 0
23/01/2013
Ethics approval number [1] 289274 0
416.12
Ethics committee name [2] 289275 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 289275 0
GPO Box 2471
Adelaide SA 5001
Ethics committee country [2] 289275 0
Australia
Date submitted for ethics approval [2] 289275 0
Approval date [2] 289275 0
25/01/2013
Ethics approval number [2] 289275 0
0000031125

Summary
Brief summary
This project aims to encourage healthy eating behaviours in people with mental illness who are residing in a Community Rehabilition Care centre. We will investigate the impact of healthy eating and daily fish oil supplementation on participants' mental and cardiometabolic health over 6 months.
Trial website
www.helfimed.org
Trial related presentations / publications
Bogomolova S, Zarnowiecki DM, Wilson A, Fielder A, Procter N, Itsiopoulos C, O’Dea K, Strachan J, Ballestrin M, Champion A, Parletta N* (under revision). Dietary intervention for people with mental illness in South Australia. Health Promotion International.

Zarnowiecki D, Wilson A, Bogomolova S, Fielder A, Procter N, O’Dea K, Itsiopoulos C, Strachan J, Ballestrin M, Parletta N (2014). Effectiveness of a Mediterranean diet intervention for improving food intake in people with serious mental illness. Oral presentation, Nutrition Society of Australia (NSA) conference, 26-28 November, Hobart. Published in the Journal of Nutrition & Intermediary Metabolism, 1:27 (http://www.jnimonline.com/article/S2352-3859(14)00093-0/fulltext)

Parletta N, Zarnowiecki D, Bogomolova S, Fielder A, Wilson A, Meyer B, O’Dea K, Itsiopoulos C, Segal L, Ballestrin M, Strachan J, Champion A, Procter N (2014). People with serious mental illness have low omega-3 index – preliminary data from a pilot feasibility study (HELFIMED). Poster presentation, International Society for the Study of Fatty Acids and Lipids (ISSFAL), Stockholm, Sweden, 28 June-2 July
Public notes

Contacts
Principal investigator
Name 40122 0
Dr Natalie (Sinn) Parletta
Address 40122 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 40122 0
Australia
Phone 40122 0
+61 8 8302 1757
Fax 40122 0
Email 40122 0
natalie.parletta@unisa.edu.au
Contact person for public queries
Name 40123 0
Dr Natalie (Sinn) Parletta
Address 40123 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 40123 0
Australia
Phone 40123 0
+61 8 8302 1757
Fax 40123 0
Email 40123 0
natalie.parletta@unisa.edu.au
Contact person for scientific queries
Name 40124 0
Dr Natalie (Sinn) Parletta
Address 40124 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 40124 0
Australia
Phone 40124 0
+61 8 8302 1757
Fax 40124 0
Email 40124 0
natalie.parletta@unisa.edu.au