Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001024639
Ethics application status
Approved
Date submitted
31/07/2023
Date registered
21/09/2023
Date last updated
21/09/2023
Date data sharing statement initially provided
21/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Schizophrenia, Nutrition and Choices in Kilojoules (Cadence SNaCK)
Scientific title
A mixed-methods randomised, 12-week cross-over randomised controlled trial to establish the feasibility, acceptability, and preliminary effectiveness of two dietary interventions (prepared meals and meal kits) vs a control condition (Coles/Myer vouchers) in community-based people living with schizophrenia who are overweight or obese.
Secondary ID [1] 286134 0
None
Universal Trial Number (UTN)
Trial acronym
SNaCK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia 330726 0
schizoaffective disorder 330727 0
Obesity 330728 0
Condition category
Condition code
Mental Health 327574 327574 0 0
Schizophrenia
Diet and Nutrition 327575 327575 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will include 18 individuals with schizophrenia or schizoaffective disorder who will be randomised to either of the two intervention arms or control arm; prepared meals, meal kits or supermarket vouchers, each running for 4 weeks over a total of 12 weeks. Each participant will receive weekly, one meal per day in both 4-week intervention arms with similar numbers of calories/KJ per week. The intervention arms will not follow a specific dietary plan but will be healthy and nutricious. All participants will receive an educational brochure specifically designed for this study, at baseline including general information on healthy eating.
Pre-prepared meals will take between 6-8 minutes to cook in a microwave and the meal kits will take approximately 20-30 minutes to prepare and cook the meal.
Meal adherence will be measured using a dietitian guided self-reported daily checklist for record of consumption of prepared meals or meal kits as intended (amount, frequency, time of the day).
There is no washout period between each arm.
Intervention code [1] 291144 0
Lifestyle
Comparator / control treatment
This study will use a supermarket voucher as the control arm.
The active control group will receive a supermarket voucher for approximately $80 each week for four weeks. All participants will receive an educational brochure specifically designed for this study at baseline, including general information on healthy eating. It will be up to the individual participant how they use the supermarket vouchure.
Control group
Active

Outcomes
Primary outcome [1] 335418 0
Feasibility will be assessed from an audit of study records for recruitment and retention rates. Number of days participants use the prepared meals or meal kits, adherence to meals provided, and difficulty in meal preparation and meal wastage assessed by study specific daily checklists.
Timepoint [1] 335418 0
Recruitment and retention assessed upon conclusion of the study.
Number of days participants use the prepared meals or meal kits, adherence to meals provided, difficulty in meal preparation and meal wastage assessed by daily checklist total 21 days across each 4 week period.
Primary outcome [2] 335419 0
The primary objective in this study will be acceptability based off meal provision preference ranking and implementation. A member of the research team will use a semi-structured interview to measure acceptability with participants and /care givers. This will take approximately 20 minutes to complete and will be recorded and transcribed by the research staff.
Timepoint [2] 335419 0
week 4, week 8 and week 12 post commencement of first meal intervention
Secondary outcome [1] 424466 0
The secondary outcome for this study is effectiveness of two dietary interventions.
Diet quality will be assessed using a 24-hr dietary recall which is a 5-phase face-to-face interview, whereby the participant will be guided to iteratively provide detail about each food and drink consumed within the previous 24-hour period.
Timepoint [1] 424466 0
Baseline (week 0) and week 4 post-baseline of each intervention and control strategy.
Secondary outcome [2] 426015 0
Change in body weight in kg's will be conducted by research assistants using calibrated digital scales
Timepoint [2] 426015 0
Baseline (week 0), week 4, week 8 and week 12 post-baseline of each intervention and control strategy.
Secondary outcome [3] 426344 0
Five-a-Day Consumption Evaluation Tool (FACET) which assesses fruit and vegetable intake over the past 24 hours
Timepoint [3] 426344 0
Baseline (week 0) and week 4 post-baseline of each intervention and control strategy.
Secondary outcome [4] 426345 0
Attitudes towards food knowledge, acquisition and preparedness will be assessed as a composite outcome using the Household Food Insecurity Access Scale (HFIAS) which focuses on healthy cooking; healthy eating; affordability of a healthy meal; social connectedness around cooking and eating; healthy eating habits; cooking ability, enjoyment and satisfaction; and self-reported nutrition knowledge.
Timepoint [4] 426345 0
Baseline (week 0) and week 4 post-baseline of each intervention and control strategy.
Secondary outcome [5] 426346 0
Self-rated health and well-being (using Short Form [SF-36] Health Survey) which measures overall quality of life and covers general health, activity level and emotional and somatic complaints with associated disability
Timepoint [5] 426346 0
Baseline (week 0) and week 4 post-baseline of each intervention and control strategy.
Secondary outcome [6] 426348 0
Food insecurity measured by Household Food Insecurity Access Scale (HFIAS) which measures feelings or behaviour around food anxiety, food quality and food quantity over the previous 30 days.
Timepoint [6] 426348 0
Baseline (week 0) and week 4 post-baseline of each intervention and control strategy.
Secondary outcome [7] 426349 0
Cost-effectiveness (cost-consequence analysis) will be measured using intervention costs and effectiveness outcomes from this study combined using a cost-consequence analysis (CCA) framework to determine the cost-effectiveness of the interventions.
Timepoint [7] 426349 0
Week 4 post-baseline of each intervention and control strategy.
Secondary outcome [8] 426350 0
Exploratory effectiveness will be conducted by a Research Assistant.
Waist circumference and hip waist ratio determined using a measuring tape.
Timepoint [8] 426350 0
Baseline (week 0), week 4, week 8 and week 12 post-baseline of each intervention and control strategy.
Secondary outcome [9] 426351 0
Blood pressure determined using a digital blood pressure monitor.
Timepoint [9] 426351 0
Baseline (week 0), week 4, week 8 and week 12 post-baseline of each intervention and control strategy.
Secondary outcome [10] 426352 0
Heart rate measured manually using a digital watch.
Timepoint [10] 426352 0
Baseline (week 0), week 4, week 8 and week 12 post-baseline of each intervention and control strategy.

Eligibility
Key inclusion criteria
1. Aged between 18 and 64 years (inclusive)
2. Consumer Integrated Mental Health and Addiction (CIMHA) diagnosis of schizophrenia or schizoaffective disorder
3. BMI greater than or equal to 25kg/m2 at baseline
4. Have had less than 5% body weight increase or loss in the previous 3 months
5. Live in independent accommodation with access to a kitchen with relevant appliances and accessories
6. Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute psychiatric symptoms requiring immediate hospitalisation
2. Obesity induced by other endocrinologic disorder (e.g., Cushing Syndrome, untreated Hypothyroidism);
3. Previous surgical treatment of obesity
4. Current or prior history with risk of relapse, of a severe eating disorder
5. Any dietary allergies which preclude from safe consumption of provided meals or foods
6. Living with someone who prepares meals for them.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent Biostatistician will generate the randomisation list which will be provided to the designated Research Manager.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1:1 ratio using a computer-generated randomization table. Participants will be randomised to prepared meals (Lite n’Easy) or meal kits (Everyplate) or active control (Coles/Myer voucher for an amount similar to the cost of the other two arms i.e., ~$80 weekly).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Total sample size will be 18 people, which follows the recommendations for participatory design and user testing activities. As this is a feasibility study, no power calculations are proposed but findings will inform power calculations for future, larger and sufficiently powered RCTs in this area.
Basic tabular descriptive statistics will include sample size for each group, range of scores, means, standard deviations and coefficient of variations for continuous variables with reasonably symmetrical distributions, or median and interquartile range for highly skewed variables. We will assess any differences in baseline mean symptom severity (measured with PANSS and GAF) across the three groups using unstandardised mean differences. Changes in primary and secondary outcomes will be assessed using t-test for continuous and Mann-Whitney U test for categorical variables by comparing the mean baseline scores of all participants randomised to one arm with mean endpoint scores (at week 4) of all participants for that arm, and in the same way for the other two study arms. This within-intervention analysis will then be extended to compare the same outcomes across the three arms using ANOVA. We will also explore correlations between cognition scores and capacity to prepare meals (measured using the checklist).
Qualitative data on implementation of the two interventions including preference ranking of the three options, will be obtained via a semi-structured interview with participants and their family/carers. This interview will be recorded and transcribed by the research staff. The purpose of audio-recording is to enable a word-by-word analysis of the data which results in the identification of themes that may emerge from the participants' narratives. As such, qualitative research methods can provide an in-depth understanding of participants' perspectives and experiences with the two interventions. This will be fully explained in the Participant Information and Consent From (PICF). Verbatim discussions will be then analysed using established thematic methodology in NVivo software. The research staff have extensive experience collecting and analysing qualitative data.

Cost-effectiveness: Intervention costs and effectiveness outcomes from the pilot will be combined using a cost-consequence analysis (CCA) framework to determine the cost-effectiveness of the interventions (by our health economist, CI Snoswell). A CCA involves presenting costs and outcomes (consequences) in a disaggregated form to allow decision makers to make decisions with more information than standard cost analysis methods. Results will be presented using a partial societal perspective, considering NDIS reimbursements and required patient contributions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25297 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 25298 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 25299 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 40970 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 40971 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 40972 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 314450 0
Hospital
Name [1] 314450 0
Metro South Health Research Support Scheme
Country [1] 314450 0
Australia
Primary sponsor type
Hospital
Name
Metro South Hospital and Health Service
Address
199 Ipswich Road, Woolloongabba, QLD, 4102
Country
Australia
Secondary sponsor category [1] 316396 0
None
Name [1] 316396 0
Address [1] 316396 0
Country [1] 316396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313501 0
Metro South HREC
Ethics committee address [1] 313501 0
Level 7, Translational Research Institute BuildingPrincess Alexandra HospitalIpswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 313501 0
Australia
Date submitted for ethics approval [1] 313501 0
15/06/2023
Approval date [1] 313501 0
27/07/2023
Ethics approval number [1] 313501 0
HREC/2023/QMS/99814

Summary
Brief summary
This study will be a randomised, 12-week cross-over controlled design, the objective is to establish the feasibility, acceptability, and preliminary effectiveness of two dietary interventions (prepared meals and meal kits) vs a control condition (Coles/Myer vouchers) in community-based people living with schizophrenia who are overweight or obese.

We hypothesise that both dietary interventions will be acceptable to participants (i.e., greater than or equal to 75% of participants will use prepared meals and meal kits for greater than or equal to 50% of the trial days), and that both dietary interventions will improve metabolic and other health-related outcomes from baseline to each 4-week follow-up. We also anticipate that prepared meals, given they require the least cognitive effort to use, will be the most acceptable option out of the three study arms, and Coles/Myer vouchers the least feasible and acceptable as participants in this arm receive neither specific foods, recipes nor prepared meals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54770 0
Prof Dan Siskind
Address 54770 0
Metro South Addiction and Mental Health ServiceMobile Intensive Rehabilitation Team (MIRT)228 Logan Road Woolloongabba QLD 4102
Country 54770 0
Australia
Phone 54770 0
+61 07 33171040
Fax 54770 0
Email 54770 0
[email protected]
Contact person for public queries
Name 54771 0
Prof Dan Siskind
Address 54771 0
Metro South Addiction and Mental Health ServiceMobile Intensive Rehabilitation Team (MIRT)228 Logan Road Woolloongabba QLD 4102
Country 54771 0
Australia
Phone 54771 0
+61 07 33171040
Fax 54771 0
Email 54771 0
[email protected]
Contact person for scientific queries
Name 54772 0
Prof Dan Siskind
Address 54772 0
Metro South Addiction and Mental Health ServiceMobile Intensive Rehabilitation Team (MIRT)228 Logan Road Woolloongabba QLD 4102
Country 54772 0
Australia
Phone 54772 0
+61 07 33171040
Fax 54772 0
Email 54772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There will be no IPD sharing for this project. Group data analysis will be conducted and this data will be used for all publications


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19842Study protocol    367928-(Uploaded-31-07-2023-17-36-52)-Study-related document.docx



Results publications and other study-related documents

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