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Trial registered on ANZCTR


Registration number
ACTRN12616001239459
Ethics application status
Approved
Date submitted
26/08/2016
Date registered
6/09/2016
Date last updated
11/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The "Say No" study - a study to reduce indulgent foods in adults.
Scientific title
The “Say No” trial: a pragmatic intervention to reduce instances of indulgent energy intake behaviours
Secondary ID [1] 290026 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 300052 0
Condition category
Condition code
Public Health 299942 299942 0 0
Health promotion/education
Diet and Nutrition 299943 299943 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group one will make ratings of their hunger motivation, mood, control of eating and food cravings in the exact same way as the comparator group. In addition they will be instructed to self-monitor the number of times they have “said no” to an indulgent food/ beverage and what they have “said no” to (self-defined indulgences) recording it each day in a booklet. Participants will receive a leaflet of how to say no to food pushers developed by the research team (led by a clinical psychologist). This leaflet provides strategies of how to say No and gives specific examples for situations e.g. if there is cake offered at work. This brief intervention will be delivered by a member of the research team who has received training by the PI (PhD in behavioural medicine). The research team consists of a dietician and research assistant although as this is a brief behavioural intervention no specific qualifications are needed. The intervention is a brief intervention and will be explained at the first visit (30 minutes)and participants will be asked to complete this for 8 weeks.

Previous research has shown that people snack on average 14 times per week, and thus we will ask participants to “say no” to indulgent foods and beverages seven times per week (thus forming implementation intentions, and prompting goal setting).

This is an extract of the script we will use to explain the intervention: “As we live in an environment where there are many opportunities to eat and drink sometimes we need to “say no” to indulgent foods and drinks to control our weight. Therefore we are asking you to “say no” seven times across the week. You can decide which indulgences you would like to “say no” to as we don’t want to be prescriptive because everyone’s eating behaviours are different. We also don’t want you to “say no” to everything as that would be very hard to continue with in the longer term. It also means that you can still have indulgences but control how many indulgences you have.

“Saying No” could be to something that is offered to you e.g. a slice of cake at work. It could also be if an opportunity presents its self, e.g. if you are at the café counter ordering a coffee and you consider purchasing a sausage roll or croissant but decide to “say no”. We also know that by writing down when you “say no” helps promote self-control. Therefore we would you like to record it in the booklet provided.”

Intervention group two will have further support in the form of feedback, and will receive the same intervention as group one but will also be asked to send a photograph or detailed description of what they have successfully “said no” to via text message (self-monitoring of behaviour). Participants will then receive feedback about how many kilojoules they have saved by “saying no”. (The number of kilojoules avoided will be calculated using the Foodworks programme). Investigators will have three hours to response to a text message if during work hours and 15 hours to respond outside of work hours and on weekends The text messages will be tailored by name and appropriate calories to the individual as this is associated with greater behaviour change than generic messages

Intervention code [1] 295742 0
Behaviour
Comparator / control treatment
The comparator group will be instructed to make ratings of their hunger motivation, mood, control of eating and food cravings in an electronic record every four days.
Control group
Active

Outcomes
Primary outcome [1] 299433 0
The participants will be asked to record the number of self-defined indulgences for seven days prior to attending the baseline appointment and for seven days starting at week seven (end of intervention). Participants will be asked to record the time of the indulgence and a description of the indulgence. The primary outcome is the change in the number of indulgences between the intervention groups and control group.
Timepoint [1] 299433 0
Change between baseline and 8 weeks
Secondary outcome [1] 327133 0
Change in control of eating questionnaire score
Timepoint [1] 327133 0
Change of these measures between baseline and eight weeks.
Secondary outcome [2] 327134 0
Assessment of feasibility
In this trial the recruitment rate, feasibility of delivering the intervention, the acceptance of the control intervention, intervention adherence and questionnaire completion rates will be measured.
Timepoint [2] 327134 0
eight weeks
Secondary outcome [3] 327233 0
Change in self-regulation as measured by the short self-regulation questionnaire,
Timepoint [3] 327233 0
Change of these measures between baseline and eight weeks.
Secondary outcome [4] 327236 0
The number of individuals assessed for eligibility and the number randomised will be calculated as an estimate of the recruitment rate required for the full trial.
Timepoint [4] 327236 0
baseline
Secondary outcome [5] 327237 0
The number of participants completing the online questionnaires and follow-up rates will be examined descriptively by group allocation.
Timepoint [5] 327237 0
eight weeks
Secondary outcome [6] 327238 0
The acceptability of the psychometric questionnaires will be examined by identifying missing data.
Timepoint [6] 327238 0
eight weeks
Secondary outcome [7] 327239 0
The adherence to the intervention will be measured through the self-monitoring records.
Timepoint [7] 327239 0
eight weeks
Secondary outcome [8] 327240 0
The average numbers of text messages sent by group two, and the number of replies will be reported.
Timepoint [8] 327240 0
eight weeks

Eligibility
Key inclusion criteria
Participants must be aged greater than or equal ro 18 years with a BMI greater than or equal to 25 kg/m2
Participants would like to reduce the number of indulgent foods and drinks they have.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or intending to fall pregnant within the study time period.
Current eating disorder or medical history of eating disorders.
Taking part in a clinical weight loss trial.
Currently attending a weight management programme (including pharmacotherapy or current/previous bariatric surgery).
Use of weight loss medications and other drugs that may affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids.
A history or presence of malignancy [completely resected basal or squamous cell carcinoma of the skin if treatment completed > 6 months prior to enrolment and Participant is in remission for > 5 years prior to Screening remain eligible].

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)
Randomisation will be conducted using opaque sequentially numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
As this is a feasibility trial all outcomes will be reported descriptively by group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14137 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 294393 0
University
Name [1] 294393 0
The University of Sydney
Address [1] 294393 0
Charles Perkins Centre
The University of Sydney
NSW
2006
Country [1] 294393 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 293262 0
None
Name [1] 293262 0
Address [1] 293262 0
Country [1] 293262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295815 0
Royal Prince Alfred Hospital Research Ethics and Governance
Ethics committee address [1] 295815 0
The Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 295815 0
Australia
Date submitted for ethics approval [1] 295815 0
19/04/2016
Approval date [1] 295815 0
14/06/2016
Ethics approval number [1] 295815 0
X16-0163 & HREC/16/RPAH/202

Summary
Brief summary
The aim of this study is to examine the feasibility of two variations of a pragmatic behavioural intervention titled “Say No” to reduce the number of indulgent foods or beverages and improve control of eating. The study design is a three arm feasibility randomised controlled trial with participants allocated to a comparator group, the “say no” intervention group or the “say no” intervention plus feedback group. Participants will have measures taken at baseline and eight weeks later. A total of 45 participants (15 in each group) will be asked to record the number of self defined indulgences for seven days at the beginning of the study and for seven days sat the end of the study. Participants will be asked to record the time of the indulgence and a description of the indulgence. The participant’s weight will be measured at baseline and eight weeks and height will be measured at baseline. Other measures that will take place at baseline and eight weeks include completion of the "Control of eating
questionnaire"; "Self regulation questionnaire" and "factor of eating questionnaire". We will also ask participants to report any medications they are taking and ask if they have been diagnosed with any comorbidities. This is to enable us to describe the
population and to identify whether the inclusion/ exclusion criteria is appropriate.

Interventions
Group one will be instructed to make ratings of their hunger motivation, mood, control of eating and food cravings in an electronic record every four days. A link to the online record will be by sent by email or text message.
Group two will also make ratings of their hunger motivation, mood, control of eating and food cravings in the exact same way as group one. In addition they will be instructed to self-monitor the number of times they have “said no” and what they have “said no” to (self defined indulgences) recording it each day in a booklet. Participants will also be given methods and tips of how to implement the “say no” intervention at baseline. Group 3 will receive the same intervention as group two but will also be asked to send a photograph or detailed description of what they have “said no” to via text message (self-monitoring of behaviour). Participants will then receive feedback about how many kilojoules they have saved by “saying no”. The text messages will be tailored to the individual as this is associated with greater behaviour change than generic messages. As this is a feasibility trial results will be analysed descriptively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68578 0
Dr claire madigan
Address 68578 0
The University of Oxford, Radcliffe Observatory Quarter, Oxford, OX26GG
Country 68578 0
United Kingdom
Phone 68578 0
+441865289340
Fax 68578 0
Email 68578 0
claire.madigan@phc.ox.ac.uk
Contact person for public queries
Name 68579 0
Dr Claire Madigan
Address 68579 0
The University of Oxford, Radcliffe Observatory Quarter, Oxford, OX26GG
Country 68579 0
United Kingdom
Phone 68579 0
+441865289340
Fax 68579 0
Email 68579 0
claire.madigan@sydney.edu.au
Contact person for scientific queries
Name 68580 0
Dr claire madigan
Address 68580 0
THE UNIVERSITY OF SYDNEY
Level 2 Charles Perkins Centre D17
The University of Sydney NSW 2006
Country 68580 0
Australia
Phone 68580 0
+61286271990
Fax 68580 0
Email 68580 0
claire.madigan@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary