Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000796280
Ethics application status
Approved
Date submitted
8/05/2018
Date registered
10/05/2018
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Date results provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
On-line cooking tips for Sleevers
Scientific title
On-line cooking tips for Sleevers: A feasibility study investigating cooking skills and diet quality for individuals at least 12 months after a Sleeve Gastrectomy
Secondary ID [1] 294819 0
Nil known
Secondary ID [2] 294820 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleeve Gastrectomy 307750 0
Condition category
Condition code
Diet and Nutrition 306806 306806 0 0
Obesity
Public Health 306841 306841 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes:

1) A cross-sectional questionnaire to evaluate the cooking skills and diet quality of individuals who previously had a Sleeve Gastrectomy (at least 12 months ago). This questionnaire will be administered at Baseline and at the end of the intervention (minus demographic questions) to measure change in cooking habits and attitudes.

2) The intervention consists of access to 10-weeks of cooking tips to encourage cooking using fresh and basic ingredients delivered via a Closed Facebook group. The research dietitian will post daily healthy cooking tips and recipes specially developed for individuals 12 months post Sleeve Gastrectomy.

At the end of the intervention participants will complete a Post Project Evaluation and this will measure how often participants read the Facebook page posts, level of relevance, usefulness and enjoyment of the intervention.

The research dietitian has 25 years of clinical experience, including 10 years supporting individuals who have had weight loss surgery.
Intervention code [1] 301132 0
Lifestyle
Intervention code [2] 301160 0
Treatment: Other
Comparator / control treatment
No treatment applied to a control group
Control group
Active

Outcomes
Primary outcome [1] 305796 0
Change in Australian Recommended Food Score (a validated measure of diet quality)
Timepoint [1] 305796 0
Baseline and at end of intervention
Secondary outcome [1] 346581 0
Change in types of ingredients used in meal preparation as measured by a questionnaire designed specially for the study
Timepoint [1] 346581 0
Baseline and at the end of the intervention
Secondary outcome [2] 346582 0
Change in food skills ability as measured by a questionnaire designed by McGowan et al (2016).
Timepoint [2] 346582 0
Baseline and at the end of the intervention
Secondary outcome [3] 346583 0
Change in food-related attitudes as measured by a questionnaire designed specially for the study and this includes questions previously used by McGowan et al (2016) and Roininen et al (1999) .
Timepoint [3] 346583 0
Baseline and at the end of the intervention
Secondary outcome [4] 346584 0
Changes in understanding of diet-disease relationships measured using a validated sub-section of a questionnaire (GNKQ-R)
Timepoint [4] 346584 0
Baseline and at the end of the intervention
Secondary outcome [5] 397183 0
Quality of life measured using the U.K Short Form Health Survey Questionnaire (UK SF-12)
Timepoint [5] 397183 0
At baseline and end of intervention

Eligibility
Key inclusion criteria
• adults (age > 18 years)
• those who have had a Sleeve Gastrectomy at least 12 months prior to recruitment
• those with daily access to the Internet and Facebook,
• those who cook a meal for themselves once a week or more.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• has special dietary requirements (eg Coeliac disease, pregnancy)

Study design
Purpose of the study
Educational / counselling / training
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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Parallel: One group receives the intervention, while the other group receives no intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a previous study we recruited 55 participants with a history of weight loss surgery (19% drop out rate). They reported low diet quality measured using the Australian Recommended Food Score (ARFS): mean 34.9 (SD 9.04). This standard deviation (9) was used to calculate the required sample size for comparing two means. 37 participants per group is required to detect a 6 unit difference in ARFS with 80% power at a significance level of 0.05. A further 7 participants per group allows for drop outs (19%). Based on these calculations a total of 88 participants are required.

Data will be analysed using STATA. Descriptive statistics will be used to describe demographic characteristics of participants (age, sex, BMI category, Socio-economic indexes for areas decile, education). Differences in participant characteristics of participants who completed and who did not will be examined using chi-square tests. Statistical comparisons will be performed on the pre and post-intervention scores for food skills, nutrition knowledge and diet quality using paired t-tests for normally distributed variables and Mann-Whitney U-tests for non-normally distributed variables. Differences between groups will be assessed using independent two-sample t tests and one-way ANOVA to assess between group differences (e.g. BMI category, sex, age group) and association with scores for food skills, nutrition knowledge and diet quality. Descriptive statistics will be undertaken to evaluate participant satisfaction with the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2018
Actual
16/04/2019
Date of last participant enrolment
Anticipated
20/08/2018
Actual
31/05/2019
Date of last data collection
Anticipated
26/11/2018
Actual
6/12/2019
Sample size
Target
88
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22606 0
2290 - Gateshead

Funding & Sponsors
Funding source category [1] 299417 0
Self funded/Unfunded
Name [1] 299417 0
Country [1] 299417 0
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
Newcastle NSW
Country
Australia
Secondary sponsor category [1] 298703 0
Commercial sector/Industry
Name [1] 298703 0
Surgery Central
Address [1] 298703 0
Suite 1, Level 2
6-8 Sydney St
Gateshead
NSW 2290
Country [1] 298703 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300317 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 300317 0
Ethics committee country [1] 300317 0
Australia
Date submitted for ethics approval [1] 300317 0
11/05/2018
Approval date [1] 300317 0
20/09/2018
Ethics approval number [1] 300317 0
Approval number H-2018-0219

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

Contacts
Principal investigator
Name 83274 0
Prof Clare Collins
Address 83274 0
Priority Research Centre in Physical Activity and Nutrition
Faculty of Health and Medicine
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Country 83274 0
Australia
Phone 83274 0
+61 2 4921 5646
Fax 83274 0
+61 2 4921 7053
Email 83274 0
[email protected]
Contact person for public queries
Name 83275 0
Cathy Harbury
Address 83275 0
School of Health Sciences
Faculty of Health and Medicine
University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Country 83275 0
Australia
Phone 83275 0
+ 61 2 4947 8177
Fax 83275 0
+ 61 2 4947 8277
Email 83275 0
[email protected]
Contact person for scientific queries
Name 83276 0
Cathy Harbury
Address 83276 0
School of Health Sciences
Faculty of Health and Medicine
University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Country 83276 0
Australia
Phone 83276 0
+ 61 2 4947 8177
Fax 83276 0
+ 61 2 4947 8277
Email 83276 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
This request was not part of the original Human Ethics approval


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
No additional documents have been identified.