Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001664437
Ethics application status
Approved
Date submitted
29/11/2016
Date registered
2/12/2016
Date last updated
2/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Create Our Own Kai: An intensive cooking class for healthy adolescents
Scientific title
Cooking with confidence: Providing adolescents with cooking skills for a healthy life. Effects on cooking skills and confidence in the kitchen.
Secondary ID [1] 290646 0
None
Universal Trial Number (UTN)
Trial acronym
COOK
Linked study record
Project pilot study registration: ACTRN12616001605482

Health condition
Health condition(s) or problem(s) studied:
Cooking skills and confidence in the kitchen 301165 0
Wellbeing 301166 0
Diet quality 301167 0
Condition category
Condition code
Diet and Nutrition 300929 300929 0 0
Other diet and nutrition disorders
Public Health 300930 300930 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the first part of the intervention participants will attend informal, interactive cooking classes for five consecutive days. during January 2017. Each of the five days classes will last approximately seven hours and will run from Monday to Friday. Participants will learn how to cook ten meals, in groups of two, and we will provide all the food for them to do this. These classes are especially designed for adolescents and to be fun. They will be led by a trained chef and dietitian who have previously developed this prorgam and ran it successfully in South Australian schools. There will be input from local role models. Participants will also be able to ask any questions they have about food and health. We will also ask them to fill in a questionnaire about food and cooking and things related to this (e.g. physical activity, food choice) and measure their height and weight. On the last day of the classes they will cook a meal for their family, who will be invited to join the class to eat this, and to take part in another cooking and information session. At this last session, which will take part on the Friday aftternoon, the child's parent(s)/guardian(s) will be invited to attend, participants and their parents/guardians will eat together and the food served wil be that cooked by the participants that day.. This will be in an informal setting where the two people leading the cooking class (a chef and a dietitian) will talk briefly about the foods used in the recipes, plus other healthy ingredients that can be used as substitutions. Parents and children will be encouraged to ask any questions that they like about the recipes or food and nutrition in general so this session so this will be led by them, rather than the research team. Classes will take part in the University of Otago College of Education Food Technology suite, or a similar venue. There will be a register of attendance at the classes.

For the second part of the study we will give each participant food to cook at least one family meal per week for the next six weeks. We will post new recipes and competitions on a Facebook page and we will have a weekly prize draw for those who post pictures of the meals that they cook, or who take part in the competitions. At the end of the six weeks we will ask participants to fill in a questionnaire about food and cooking, and measure their height and weight.
For the third part of the study we will gradually decrease researcher participation on the Facebook page over the course of the year. Participation on the Facebook pages will be monitored.

One year follow-up (funding permitting): Participants will complete the questionnaires and be weighed and measured at one year.
Intervention code [1] 296529 0
Lifestyle
Comparator / control treatment
Participants enrolled into the control group will fill in the questionnaires and have their height and weight measured three times over the year at weeks 1, 7, and 52.
Control group
Active

Outcomes
Primary outcome [1] 300351 0
Cooking skills and self-efficacy/confidence in the kitchen assessed using an adapted version of Post-Intervention Questionnaire for Cooking Skills Programmes (Barton et al, 2011).
Timepoint [1] 300351 0
At the end of the weeks 1 and 7.
Funding pending: week 52.
Primary outcome [2] 300352 0
Diet quality: Food choice will be assessed using the NZA-FFQ and diet quality calculated from this according to Wong et al. 2103.

Development and validation of a food-based diet quality index for New Zealand adolescents.
Wong JE, Parnell WR, Howe AS, Black KE, Skidmore PM.
BMC Public Health. 2013 Jun 8;13:562. doi: 10.1186/1471-2458-13-562.
Timepoint [2] 300352 0
Week 7.
Funding pending: week 52.
Secondary outcome [1] 329759 0
Wellbeing will be assessed using the WHO-5 Well-Being Index.
Timepoint [1] 329759 0
Week 7.
Funding pending: week 52.

Eligibility
Key inclusion criteria
Year 9 to 10 students from Dunedin schools.
Minimum age
13 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students not able to provide consent.
Students whose parents have not provided consent.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be used with sealed opaque envelopes. Participants will be randomised, in the order in which they were enrolled into the trial, by the study co-ordinator who will pick one of the sealed envelopes from a bag.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Appropriate summary statistics will be presented for all measures collected. Tests for trends over time will be used for measures repeated on several occasions. Binary variables will be analysed using logistic regression. Linear regression will be used to analyse continuous variables. Standard regression diagnostics (based on residuals, linearity, and leverage points) will be used for all models with Hosmer-Lemeshow tests also used for logistic regression models. Stata 12.1 or a later version will be used for all analyses and all statistical tests will be conducted using a two-sided 0.05 level of significance and with 95% CIs presented alongside all effect sizes. The study will provide useful information for calculating sample sizes for further studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2016
Actual
Date of last participant enrolment
Anticipated
23/01/2017
Actual
Date of last data collection
Anticipated
31/01/2018
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 8424 0
New Zealand
State/province [1] 8424 0
Otago

Funding & Sponsors
Funding source category [1] 295079 0
Charities/Societies/Foundations
Name [1] 295079 0
Lotteries Health
Country [1] 295079 0
New Zealand
Funding source category [2] 295080 0
Charities/Societies/Foundations
Name [2] 295080 0
Foodstuffs South Island Community Trust
Country [2] 295080 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
P.O. Box 56
Dunedin
9054
NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 293896 0
None
Name [1] 293896 0
Address [1] 293896 0
Country [1] 293896 0
Other collaborator category [1] 279331 0
Other Collaborative groups
Name [1] 279331 0
Sprout Cooking School
Address [1] 279331 0
89 Sir Donald Bradman Dr,
Hilton SA
5033
Country [1] 279331 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296432 0
University of Otago Human Ethics Committee
Ethics committee address [1] 296432 0
Ethics committee country [1] 296432 0
New Zealand
Date submitted for ethics approval [1] 296432 0
15/08/2016
Approval date [1] 296432 0
29/08/2016
Ethics approval number [1] 296432 0
16/126

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

Contacts
Principal investigator
Name 70830 0
Dr Paula Skidmore
Address 70830 0
Department of Human Nutrition
University of Otago
P.O. Box 56
Dunedin
NEW ZEALAND
9054
Country 70830 0
New Zealand
Phone 70830 0
+ 64 3 479 8374
Fax 70830 0
+ 64 3 479 7958
Email 70830 0
[email protected]
Contact person for public queries
Name 70831 0
Caleb Robinson
Address 70831 0
Department of Human Nutrition
University of Otago
P.O. Box 56
Dunedin
9054
NEW ZEALAND
Country 70831 0
New Zealand
Phone 70831 0
+ 64 21 0446404
Fax 70831 0
Email 70831 0
[email protected]
Contact person for scientific queries
Name 70832 0
Paula Skidmore
Address 70832 0
Department of Human Nutrition
University of Otago
P.O. Box 56
Dunedin
9054
NEW ZEALAND
Country 70832 0
New Zealand
Phone 70832 0
+ 64 3 479 8374
Fax 70832 0
Email 70832 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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