Eating Behaviour of Discretionary FoodsFOODSNCT04657627
FOODS: Food shOppers' sOcial meDia Study
A study testing PACE plus calorie labelling information and Calorie-only labelling information in people with Eating Behaviour of Discretionary Foods and Cognitive Restraint of Eating, run by Loughborough University at 1 site in United Kingdom.
Trial summary
This study aims to assess the effects of a new approach to food labelling called physical activity calorie equivalent (PACE) labelling. PACE food labelling provides the public with information about how many minutes (or miles/kilometres) of physical activity (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behaviour of Discretionary Foods, Cognitive Restraint of Eating, Physical Activity
- What is being tested?
- PACE plus calorie labelling information and Calorie-only labelling information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2021to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years old.
- BMI of ≥ 18.5 kg/m2.
- ≤ 3kg weight loss in previous 6 months.
- Access and ability to use personal Twitter and/or Instagram account via own smartphone, computer or tablet device.
- Access to the internet.
- Access to a set of weighing scales.
Who cannot join
- Unable to read and understand English.
- Experienced in the last 12 months or currently undergoing any of the following conditions or illnesses: coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease (COPD), painful condition, dementia and cancer.
- Had bariatric surgery.
- Pregnant, lactating or planning to become pregnant in the next 12 months.
- Parallel participation in another weight, dietary or physical activity intervention study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
This study aims to assess the effects of a new approach to food labelling called physical activity calorie equivalent (PACE) labelling. PACE food labelling provides the public with information about how many minutes (or miles/kilometres) of physical activity (e.g. walking or running) are equivalent to the calories contained in foods.
- Conditions
- Eating Behaviour of Discretionary Foods, Cognitive Restraint of Eating, Physical Activity, Body Weight
- Being tested
- PACE plus calorie labelling information, Calorie-only labelling information
- Keywords
- Nutrition labelling, Physical activity, Social media
- Medical subject headings
- Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACE plus calorie labelling informationBehavioural
The intervention group will be exposed to PACE plus calorie labelling information via Instagram and Twitter social media posts every day for 13 weeks.
Calorie-only labelling informationBehavioural
The comparator group will be exposed to calorie-only labelling information via Instagram and Twitter social media posts every day for 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PACE plus calorie information intervention group | Experimental | PACE plus calorie information intervention group will receive PACE plus calorie information of discretionary foods via social media posts. Receives: Behavioral: PACE plus calorie labelling information |
| Calorie-only information comparator group | Active comparator | Calorie-only information comparator group will receive calorie-only information of discretionary foods via social media posts. Receives: Behavioral: Calorie-only labelling information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eating behaviour of discretionary foods at 13 weeks
Eating behaviour of discretionary foods will be assessed by a modified version of Online Food Frequency Questionnaire (eNutri FFQ), designed to measure habitual food intake. Participants will record frequencies of discretionary food and drink items eaten during the last month (e.g. "1/week" or "1/day").
Measured: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
Secondary outcomes (3)
Cognitive restraint of eating
A modified version (R18) of the Three-Factor Eating Questionnaire (TFEQ) will be used to measure cognitive restraint.
Measured: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
Physical activity
Self-reported physical activity behaviour will be assessed using the 7-day International Physical Activity Questionnaire (IPAQ)
Measured: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
Body weight
Weight will be self-reported via participants own weighing scales. Participants will electronically send via email photograph evidence of readings of their fasted morning weight from weighing scales, following standardised instructions.
Measured: Pre-baseline (one time point prior to randomisation), mid-intervention (week 7) and post-intervention (one time point after week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start6 Jan 2021
- Primary completion30 Sep 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Behaviour of Discretionary FoodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised to one of two groups for 13 weeks: (i) PACE plus calorie information intervention group or (ii) calorie-only information comparator group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Oonagh Markey, Alexandra Todd
- Responsible party
- Principal investigator, Amanda Daley, Loughborough University
- Investigators
- Amanda Daley, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657627
- Sponsor's protocol ID
- 1544
- Acronym
- FOODS
- Status last verified
- Oct 2021
- First submitted
- 24 Nov 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOODS: Food shOppers' sOcial meDia Study
- ClinicalTrials.gov ID
- NCT04657627
- Acronym / sponsor ID
- FOODS / 1544
- Conditions
- Eating Behaviour of Discretionary Foods, Cognitive Restraint of Eating, Physical Activity, Body Weight
- Keywords
- Nutrition labelling, Physical activity, Social media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Dr Oonagh Markey, Alexandra Todd
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effects of a new approach to food labelling called physical activity calorie equivalent (PACE) labelling. PACE food labelling provides the public with information about how many minutes (or miles/kilometres) of physical activity (e.g. walking or running) are equivalent to the calories contained in foods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomised to one of two groups for 13 weeks: (i) PACE plus calorie information intervention group or (ii) calorie-only information comparator group.
| Arm | Type | Receives |
|---|---|---|
| PACE plus calorie information intervention group | Experimental | Behavioral: PACE plus calorie labelling informationPACE plus calorie information intervention group will receive PACE plus calorie information of discretionary foods via social media posts. |
| Calorie-only information comparator group | Active comparator | Behavioral: Calorie-only labelling informationCalorie-only information comparator group will receive calorie-only information of discretionary foods via social media posts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years old.
- BMI of ≥ 18.5 kg/m2.
- ≤ 3kg weight loss in previous 6 months.
- Access and ability to use personal Twitter and/or Instagram account via own smartphone, computer or tablet device.
- Access to the internet.
Key exclusion criteria (5 listed)
- Unable to read and understand English.
- Experienced in the last 12 months or currently undergoing any of the following conditions or illnesses: coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease (COPD), painful condition, dementia and cancer.
- Had bariatric surgery.
- Pregnant, lactating or planning to become pregnant in the next 12 months.
- Parallel participation in another weight, dietary or physical activity intervention study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACE plus calorie labelling informationThe intervention group will be exposed to PACE plus calorie labelling information via Instagram and Twitter social media posts every day for 13 weeks. | Behavioural | PACE plus calorie information intervention group |
| Calorie-only labelling informationThe comparator group will be exposed to calorie-only labelling information via Instagram and Twitter social media posts every day for 13 weeks. | Behavioural | Calorie-only information comparator group |
Primary outcome
Change in eating behaviour of discretionary foods at 13 weeks
Time frame: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
Eating behaviour of discretionary foods will be assessed by a modified version of Online Food Frequency Questionnaire (eNutri FFQ), designed to measure habitual food intake. Participants will record frequencies of discretionary food and drink items eaten during the last month (e.g. "1/week" or "1/day").
3 secondary outcomes
Cognitive restraint of eating
Time frame: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
Physical activity
Time frame: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
Body weight
Time frame: Pre-baseline (one time point prior to randomisation), mid-intervention (week 7) and post-intervention (one time point after week 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Daley principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACE plus calorie labelling information and Calorie-only labelling information in people with Eating Behaviour of Discretionary Foods and Cognitive Restraint of Eating, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating behaviour of discretionary foods at 13 weeks (time frame: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.