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The "Say No" study - a study to reduce indulgent foods in adults.

The “Say No” trial: a pragmatic intervention to reduce instances of indulgent energy intake behaviours

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001239459
Enrollment
45
Registered
2016-09-06
Start date
2016-09-12
Completion date
2016-10-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 psy

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

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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].

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026