Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001540101
Ethics application status
Approved
Date submitted
10/10/2019
Date registered
7/11/2019
Date last updated
7/11/2019
Date data sharing statement initially provided
7/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
FoodFix: A pilot study for a personality based intervention for the management of addictive eating
Scientific title
FoodFix: A pilot study for a personality based intervention for the management of addictive eating
Secondary ID [1] 299146 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addictive eating behaviours 314298 0
Condition category
Condition code
Diet and Nutrition 312654 312654 0 0
Obesity
Mental Health 312655 312655 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete a series of questionnaires that investigate: symptoms of food addiction, dietary intake and eating behaviours /habits, questions about personality and mental health. Data collection sessions for the project will be conducted online. Participants will be asked to complete screening questionnaires and will then be assigned, at random, to an intervention group or be placed on a wait list. The intervention group will complete questionnaires at baseline, 1 month and 3 months. The wait list will complete an additional 2 sets of questionnaires once they start their intervention 1 month after commencement and then again at 3 months. The intervention group will participate in three, one-on-one telehealth intervention sessions (Vsee secure telehealth platform) of no more than 45 minutes each. Sessions can also be conducted over the phone when a internet connection is unstable. Sessions will be held over a period of two months (sessions scheduled in week 1, week 3 and week 7). The intervention will be administered by Accredited Practising Dietitians who also have experience in counselling. The intervention will assist to improve addictive eating behaviours by addressing current dietary intake and setting nutrition and health goals based on aspects of personality. The intervention incorporates Social Cognitive Theory for behaviour change and participants will be counselled via personalised feedback and Motivational Interviewing. Participants on the waitlist will receive the telehealth intervention after 3 months.
Intervention code [1] 315494 0
Behaviour
Comparator / control treatment
3-month wait list control group - no intervention will be undertaken during this time
Control group
Active

Outcomes
Primary outcome [1] 321332 0
Addictive Eating Behaviours assessed via the Yale Food Addiction Scale 2.0
Timepoint [1] 321332 0
Baseline and 3-months
Primary outcome [2] 321333 0
% Energy Core Foods assessed via the Australian Eating Survey
Timepoint [2] 321333 0
Baseline & 3-months
Primary outcome [3] 321899 0
Non-Core Foods assessed via the Australian Eating Survey
Timepoint [3] 321899 0
Baseline & 3-months
Secondary outcome [1] 374686 0
Quality of Life assessed via the Short Form-36
Timepoint [1] 374686 0
Baseline & 3-months
Secondary outcome [2] 376182 0
Weight assessed via self-report anthropometric data
Timepoint [2] 376182 0
Baseline & 3-months
Secondary outcome [3] 376183 0
Specific discretionary food intake assessed via Timeline Follow-Back tool
Timepoint [3] 376183 0
Baseline & 3-months
Secondary outcome [4] 376184 0
Coping In Stressful Situations (CISS tool)
Timepoint [4] 376184 0
Baseline & 3-months
Secondary outcome [5] 376185 0
Drug & alcohol intake assessed via the ASSIST 2.0 tool - Composite outcome
Timepoint [5] 376185 0
Baseline & 3-months

Eligibility
Key inclusion criteria
Residents of Australia exhibiting symptoms of addictive eating behaviours, are above their healthy weight range, and proficient in English, Must have suitable phone and internet access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or existing health conditions which affect dietary intake or weight status

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation sequences were generated using a computer random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait list control
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The aim is to recruit 50 (total) as to allow for up to 20% attrition. A sample size of 40 will have sufficient power to detect moderate effect sizes (i.e. d 0.4 to 0.6) on the primary outcome variable of symptoms of FA. These numbers align with the fact that this is a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/02/2018
Date of last participant enrolment
Anticipated
Actual
17/07/2018
Date of last data collection
Anticipated
Actual
17/04/2019
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303685 0
University
Name [1] 303685 0
The University of Newcastle
Country [1] 303685 0
Australia
Funding source category [2] 303795 0
Charities/Societies/Foundations
Name [2] 303795 0
Society of Mental Health Research
Country [2] 303795 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 303790 0
None
Name [1] 303790 0
Address [1] 303790 0
Country [1] 303790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304210 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 304210 0
Ethics committee country [1] 304210 0
Australia
Date submitted for ethics approval [1] 304210 0
02/06/2017
Approval date [1] 304210 0
19/10/2017
Ethics approval number [1] 304210 0
H-2017-0167

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

Contacts
Principal investigator
Name 96150 0
A/Prof Tracy Burrows
Address 96150 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 96150 0
Australia
Phone 96150 0
+61 2 49215514
Fax 96150 0
Email 96150 0
[email protected]
Contact person for public queries
Name 96151 0
Tracy Burrows
Address 96151 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 96151 0
Australia
Phone 96151 0
+61 2 49215514
Fax 96151 0
Email 96151 0
[email protected]
Contact person for scientific queries
Name 96152 0
Tracy Burrows
Address 96152 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 96152 0
Australia
Phone 96152 0
+61 2 49215514
Fax 96152 0
Email 96152 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4658Ethical approval    378273-(Uploaded-09-09-2019-12-10-44)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCharacteristics of individuals seeking addictive eating treatment.2021https://dx.doi.org/10.1007/s40519-021-01147-y
EmbaseThe feasibility of a personality targeted intervention for addictive overeating: FoodFix.2021https://dx.doi.org/10.1016/j.appet.2020.104974
N.B. These documents automatically identified may not have been verified by the study sponsor.