Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001144101
Ethics application status
Approved
Date submitted
18/07/2019
Date registered
16/08/2019
Date last updated
16/08/2019
Date data sharing statement initially provided
16/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Edith Cowan University (ECU) Lifestyle and Biomarker controlled intervention study of Jamie's Ministry of Food WA participant experience
Scientific title
Does the Jamie's Ministry of Food WA cooking program build self-efficacy? The ECU Lifestyle and Biomarker controlled intervention study of participants and their experience of a seven week cooking program.
Secondary ID [1] 298481 0
Nil
Universal Trial Number (UTN)
Trial acronym
ECULABJMOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet and Nutrition 313255 0
Mental Health 313256 0
Metabolic and endochrine 313257 0
Public Health 313258 0
Cardiovascular 313259 0
Condition category
Condition code
Diet and Nutrition 311696 311696 0 0
Other diet and nutrition disorders
Mental Health 311697 311697 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 311698 311698 0 0
Metabolic disorders
Public Health 311699 311699 0 0
Health promotion/education
Cardiovascular 311700 311700 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation in a cooking program designed by Jamie's Ministry of Food (JMOF) and delivered by The Good Foundation in partnership with Edith Cowan University, from the fully equipped JMOF mobile kitchen at various locations in WA. Participants attended a 1.5 hour hands-on cooking session once a week for seven weeks and were taught basic cooking skills to help people prepare simple, fresh, healthy food quickly and cheaply. Classes were delivered by a trained qualified nutritionist who demonstrated the recipe of the day which participants then cooked for themselves in groups of four to a work station. Each week there was a new Jamie Oliver recipe covering every meal from breakfast and sides to lunch and dinner. Participants were taught knife skills and techniques and how to bring out the best flavours from fresh ingredients. They also learned how to plan and budget to make food go further. The mobile kitchen can accommodate 12 participants, cooking in groups of four with the supervision of one demonstrator and 2 trained interns. Inclusion criteria included all individuals who signed up for the program who were aged 18 years and above and who volunteered for evaluation participation; no other inclusion or exclusion criteria were applied. Subsequent sampling for the intervention group was purposive from the program registration database and was determined by the day of the week the participant had allocated for their class. (i.e. Tuesday, Wednesday, Friday or Saturday)
Intervention code [1] 314733 0
Lifestyle
Intervention code [2] 314734 0
Treatment: Other
Comparator / control treatment
Control group subjects were those who met the inclusion criteria (all individuals who signed up for the program who were aged 18 years and above and who volunteered for evaluation participation; no other inclusion or exclusion criteria were applied) and were registered on the program's waitlist with an allocated class on a control day (i.e. Monday or Thursday). Control participants were studied during the six week period leading up to their their participation in the cooking program thereby representing those who had not undergone the intervention. Control T1 was 6 weeks prior and control T2 was one week before the program began.
Control group
Active

Outcomes
Primary outcome [1] 320396 0
Composite changes in participants' skills, attitudes, knowledge, enjoyment and satisfaction of cooking and cooking confidence (self-efficacy) measured using an online survey developed by Flego et. al. 2013 and ECU.
Timepoint [1] 320396 0
Timepoint: IT1 Baseline, before the start of the cooking program,IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program.
Secondary outcome [1] 371468 0
Composite changes in dietary and beverage intake, measured using a hard copy version of the Dietary Questionnaire for Epidemiological Studies Version 2 (DQES v2) developed by Cancer Council Victoria (Ireland 1994).
Timepoint [1] 371468 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program.
Secondary outcome [2] 371470 0
Composite changes in mental health and wellbeing, measured using the 12-Item Short Form Survey (SF-12: Ware 1992), The Subjective Vitality Scale (SVS: Ryan & Frederick, 1997) and The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS: Stewart-Brown 2011)
Timepoint [2] 371470 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program.
Secondary outcome [3] 371474 0
Ccomposite changes in body composition such as body fat/fat-free mass percentages using the BOD POD air displacement plethysmography, Dual Energy X-ray Absorptiometry (DXA) and Impedimed Imp DF50 tetrapolar bioelectrical impedence analyser (BIA) depending on location.
Timepoint [3] 371474 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program.
Secondary outcome [4] 371483 0
Composite anthropometric measurements including weight (kg), BMI (kg/m2) and waist circumference (cm). Standing height and body mass measured to the nearest 0.1cm and 0.1kg respectively with a SECA 763 digital column scale (SECA Ltd, USA), waist circumference measured at the narrowest part of the waist by a Lufkin steel tape measure to the nearest 0.1cm. All measurements conducted according to standardised ISAK techniques
Timepoint [4] 371483 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program.
Secondary outcome [5] 371486 0
Changes in blood pressure using an Omron IA1B Automated Blood Pressure Device (Omron Healthcare Ltd, Japan)
Timepoint [5] 371486 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program.
Secondary outcome [6] 371487 0
Composite changes in blood biomarkers of inflammation and metabolism associated with physical and mental health, such as fasting blood lipids, glucose and high sensitivity C-reactive protein, advanced glycation end products (IgG N-glycans), measured by routine laboratory methods.
Timepoint [6] 371487 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program
Secondary outcome [7] 371488 0
Changes to hand grip strength (kg), measured using a Jamar Analogue Hand Dynamometer on the dominant hand (Massy-Westropp 2011)..
Timepoint [7] 371488 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program
Secondary outcome [8] 373577 0
Changes in microbial composition measured by analysis of DNA extracted using the QIAamp PowerFecal DNA kit (Qiagen) using Qiacube extraction platform.
Timepoint [8] 373577 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program
Secondary outcome [9] 373578 0
Changes in faecal bile acids as a measure of bile acid and cholesterol metabolism, using high performance liquid chromatography.
Timepoint [9] 373578 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program
Secondary outcome [10] 373579 0
Composite changes in short chain fatty acids (SCFA) and other metabolites in stool samples as measures of fibre and protein fermentation using gas chromatography mass spectrometry.
Timepoint [10] 373579 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program
Secondary outcome [11] 373580 0
Composite changes in blood biomarkers of bacterial associated gut health, such as serotonin, lipopolysaccharide (LPS) and zonulin measured by routine laboratory methods.
Timepoint [11] 373580 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program
Secondary outcome [12] 373581 0
Composite physical activity and mobility levels, measured using the International Physical Activity Questionnaire (IPAQ) self-administered short-form (Craig 2003), the Godin Leisure-Time Exercise Questionnaire (Godin & Shephard 1997) and the timed "Up & Go" test (Podsiadlo & Richardson 1991).
Timepoint [12] 373581 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program
Secondary outcome [13] 373582 0
Composite changes in blood biomarkers of fruit and vegetable intakes, such as carotenoid concentration (a-carotene, ß-carotene) measured by routine laboratory methods.
Timepoint [13] 373582 0
Timepoint: IT1 Baseline, before the start of the cooking program, IT2 at the end of the cooking program at 7 weeks (primary timepoint) and IT3 at 6 months after the cooking program

Eligibility
Key inclusion criteria
Inclusion criteria included anyone who enrolled in the cooking program aged 18 years and above, who volunteered for evaluation participation; no other inclusion or exclusion criteria were applied.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There were no exclusion criteria beyond those who signed up for the cooking program who were under 18 years of age.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sampling for the control and intervention groups was purposive from the cooking program registration database. Control group subjects were those who met the inclusion criteria and were waiting to participate in the program and who had selected a class on a control day (i.e. Monday or Thursday). Intervention group subjects were those who met the inclusion criteria and had a place allocation on any other day of the week (Tuesday, Wednesday, Friday or Saturday). Four tiers of participation were offered to participants with increasing levels of involvement from the basic level ; completion of the on-line questionnaire, primary outcome 1: level 2; primary outcome 1, plus secondary outcomes 1 to 6: level 3; primary outcome 1, plus secondary outcomes 1 to 7: and level 4; primary outcome 1 plus secondary outcomes 1 to 8.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using G*Power and based on previous JMOF evaluation studies, the required sample for a mixed-model analysis of variance (ANOVA) design (2 groups, each with 2 time points) to detect a small to medium within-between interaction effect (Cohen’s F = 0.15) at the 5% level of significance and 80% power was 90, or 45 per group. For the analysis of the intervention group across three time points using a repeated-measures ANOVA, the required sample to detect a small to medium within-group effect (Cohen’s F = 0.15) at the same level of significance and power was 73.
The computer software package IBM SPSS Statistics 25 will be used to access the data set and perform the statistical analyses. For the basic on-line evaluation questionnaire general descriptive analyses including frequency data with appropriate plots and cross-tabulations will be used to explore and summarise outcome variables. Continuous demographic and baseline characteristics will be summarised using standard statistics (mean and standard deviation) and non-parametric statistics (medians and inter-quartile ranges) where appropriate. Independent t-test for normally distributed data, and Mann-Whitney U test for non-normal data, will be used to assess differences between the groups. Frequencies and percentages will be reported for categorical variables and Chi-square test will be used to test for differences in proportion between the groups. Primary outcomes (continuous) are participants' skills, attitudes, knowledge, enjoyment and satisfaction of cooking and cooking confidence (self-efficacy), measured using the standard online questionnaire. The magnitude of change both within (IT1 and IT2 and CT1 and CT2 time points) and between the intervention and control groups will be assessed using mixed-model ANOVA. Furthermore, changes within the intervention group will be assessed across three time points IT1, IT2 and IT3 using repeated-measures ANOVA. Specific demographic factors of interest (e.g. gender, age, education) will be adjusted in all models. Results will be deemed significant at the P=0.050 level.
To interpret gut microbiota diversity and to analyse the microbial composition of the gut microbiota, multivariate analysis using a combination of R and PRIMER7 and Permanova+ (PRIMER-E, Plymouth) will be conducted. Principal Coordinates Analysis (PCoA) will be deployed to visualise findings. Whereas, distance-based linear models (DISTLM) and distance-based redundancy analysis (dbRDA) will be used to integrate microbiome findings with other relevant data (i.e. dietary intake) that help explain the relationship between the microbiome findings and other outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/05/2016
Date of last participant enrolment
Anticipated
Actual
1/11/2018
Date of last data collection
Anticipated
Actual
25/06/2019
Sample size
Target
74
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303026 0
University
Name [1] 303026 0
Edith Cowan University
Country [1] 303026 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup, Perth, Western Australia, 6027,
Country
Australia
Secondary sponsor category [1] 303004 0
None
Name [1] 303004 0
Address [1] 303004 0
Country [1] 303004 0
Other collaborator category [1] 280736 0
Charities/Societies/Foundations
Name [1] 280736 0
The Good Foundation
Address [1] 280736 0
169 Park Street, Melbourne, Victoria 3205
Country [1] 280736 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303575 0
ECU Human Research Ethics Committee (HREC)
Ethics committee address [1] 303575 0
Ethics committee country [1] 303575 0
Australia
Date submitted for ethics approval [1] 303575 0
01/04/2016
Approval date [1] 303575 0
29/04/2016
Ethics approval number [1] 303575 0
15362:Newton

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94138 0
Prof Amanda Devine
Address 94138 0
Edith Cowan University, School of Medical and Health Sciences,
270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 94138 0
Australia
Phone 94138 0
+61 08 6304 5527
Fax 94138 0
Email 94138 0
[email protected]
Contact person for public queries
Name 94139 0
Joanna Rees
Address 94139 0
Edith Cowan University,School of Medical and Health Sciences,
270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 94139 0
Australia
Phone 94139 0
+61 08 6304 2939
Fax 94139 0
Email 94139 0
[email protected]
Contact person for scientific queries
Name 94140 0
Amanda Devine
Address 94140 0
Edith Cowan University,School of Medical and Health Sciences,
270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 94140 0
Australia
Phone 94140 0
+61 08 6304 2939
Fax 94140 0
Email 94140 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 is a Consulting services deed agreement between ECU and The Good Foundation which prohibits the disclosure of data for this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe study protocol for a pseudo-randomised pre-post designed controlled intervention trial to study the effects of a 7-week cooking program on self-efficacy and biomarkers of health: the ECU lifestyle and biomarkers get connected study (ECULABJMOF) including the Jamie's Ministry of Food WA participant experience.2020https://dx.doi.org/10.1186/s12889-020-09124-3
N.B. These documents automatically identified may not have been verified by the study sponsor.