Diet ModificationNCT03601650
The Effect of Mindful Eating on Calorie Intake and Diet
A study testing Mindful eating and Eating without distractions in people with Diet Modification, run by City, University of London at 1 site in United Kingdom.
Trial summary
The study will examine the effect of focussing on the sensory properties of food whilst eating. It will look at effects on calorie intake and diet over a 3-day period among women of a healthy weight. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Mindful eating and Eating without distractions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2017to 1 Feb 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent English speaker
- BMI of 20 to 25 based on reported weight and height
- Access to data or wifi during the evenings
Who cannot join
- Dieting to lose weight
- Taking medication that may affect appetite
- Current or previous diagnosis of an eating disorder
- Completion of related studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindful Eating on Calorie Intake and Diet Over a 3-day Period Among Healthy Weight Women.
The study will examine the effect of focussing on the sensory properties of food whilst eating. It will look at effects on calorie intake and diet over a 3-day period among women of a healthy weight. Participants asked to focus on the sensory properties of their food will be compared with a second group of participants who will be asked to eat their food without distractions and a third group who will not be provided with any strategy.
Read the detailed description
The research will be conducted as a between subject design over a period of three days (Tuesday-Thursday). Upon arrival at the laboratory (on a Monday), participants will be provided with more information about the study and will complete a demographics questionnaire. A smartphone app will be downloaded onto the participant's phone and the participant will be provided with login details to access the food diary Intake24. Participants will be asked to complete the food diary every night over a period of three days. The diary will ask participants to record what they consumed for breakfast, lunch, dinner, as well as snack on a daily basis. All participants will receive a reminder notification on their phone each evening during the 3-day period to complete the Intake 24 food diary. They will also be asked to rate how well they think they remembered the food they had eaten that day.
During the 3-day period, some participants will also be asked to open reminders in sealed envelopes at particular times of the day. The app will additionally include a recording that participants will be able to listen to at their own convenience, as many times as they wish.
The content of the reminders and recording will differ between participants depending on the condition they are allocated to. There will be three conditions: intervention, no distraction control, and no strategy control.
In the intervention condition, participants will open reminders related to focusing on the sensory properties of their food while eating their meals. These participants will also have access to a recording that will encourage them to focus on the sensory properties of the food (e.g. its smell, look, texture).
Participants in the no distraction control condition will open reminders related to eating their meals with no distractions. The recording provided to participants in this condition will encourage them to consume their meals with no surrounding distractions (e.g. to avoid watching television or listening to the radio). During the study, the number of times the recording is played as well as the date and time it is played will be recorded.
In the intervention and no distraction control group, at the end of each of the three days participants will also be asked to rate the extent to which they adhered to the strategy they were provided with.
In the no strategy control condition, participants will not receive any reminders to open or have access to a recording.
After the three days (i.e. on a Friday), participants will return to the laboratory. They will be asked to complete a questionnaire regarding the usability of the mobile app and the online food diary. Via this questionnaire, they will also be asked about whether they thought taking part in the study influenced their eating behaviour and the amount of pleasure they got from their food during the three-day period. Additionally they will complete a questionnaire measuring sensitivity to reward. At this session participants will be asked if they are happy to have their weight and height measured. If they are, the researcher will measure their weight and height.
- Conditions
- Diet Modification
- Being tested
- Mindful eating, Eating without distractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful eatingBehavioural
Also called Attentive eating
Attending to the sensory properties of food as it is eaten
Eating without distractionsBehavioural
Eating without intentionally attending to something else such as a television, smartphone, computer, book etc
| Study group | Role | What they receive |
|---|---|---|
| Mindful eating | Experimental | Participants will be encouraged to focus on the sensory properties of their food every time they eat. This will be achieved via an audio recording that they will listen to in the laboratory at their first appointment and that they will have access to over the three-day intervention period. They will also receive a pack of envelopes to open over the intervention period that will also contain reminders to focus on the sensory properties of their food every time they eat. Receives: Behavioral: Mindful eating |
| Eating without distractions | Active comparator | Participants will be encouraged to eat their food without distractions every time they eat. This will be achieved via an audio recording that they will listen to in the laboratory at their first appointment and that they will have access to over the three-day intervention period. They will also receive a pack of envelopes to open over the intervention period that will also contain reminders to eat their food without distractions every time they eat. Receives: Behavioral: Eating without distractions |
| No strategy control | No intervention | Participants will simply complete the measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calorie intake
Total calorie intake over three days
Measured: Three days during intervention delivery
Secondary outcomes (4)
Intake of non milk extrinsic sugars
Total intake (in grams) of non milk extrinsic sugars over the three days
Measured: Three days during intervention delivery
Intake of saturated fat
Total intake (in grams) of saturated fat over the three days
Measured: Three days during intervention delivery
Fruit and vegetable intake
Total intake (in grams) of fruit and vegetables, excluding juices, smoothies, potatoes and legumes
Measured: Three days during intervention delivery
Intake of fibre
Total intake (in grams) of fibre (using the Englyst measure)
Measured: Three days during intervention delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start21 Jan 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katy Tapper, City, University of London
- Investigators
- Katy Tapper, PhD, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601650
- Sponsor's protocol ID
- PSYETH (R/L) 16/17 92
- Status last verified
- Jan 2020
- First submitted
- 17 Jul 2018
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindful Eating on Calorie Intake and Diet Over a 3-day Period Among Healthy Weight Women.
- ClinicalTrials.gov ID
- NCT03601650
- Acronym / sponsor ID
- PSYETH (R/L) 16/17 92
- Conditions
- Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 26 Jul 2018 (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.
The study will examine the effect of focussing on the sensory properties of food whilst eating. It will look at effects on calorie intake and diet over a 3-day period among women of a healthy weight. Participants asked to focus on the sensory properties of their food will be compared with a second group of participants who will be asked to eat their food without distractions and a third group who will not be provided with any strategy.
Detailed description
The research will be conducted as a between subject design over a period of three days (Tuesday-Thursday). Upon arrival at the laboratory (on a Monday), participants will be provided with more information about the study and will complete a demographics questionnaire. A smartphone app will be downloaded onto the participant's phone and the participant will be provided with login details to access the food diary Intake24. Participants will be asked to complete the food diary every night over a period of three days. The diary will ask participants to record what they consumed for breakfast, lunch, dinner, as well as snack on a daily basis. All participants will receive a reminder notification on their phone each evening during the 3-day period to complete the Intake 24 food diary. They will also be asked to rate how well they think they remembered the food they had eaten that day.
During the 3-day period, some participants will also be asked to open reminders in sealed envelopes at particular times of the day. The app will additionally include a recording that participants will be able to listen to at their own convenience, as many times as they wish.
The content of the reminders and recording will differ between participants depending on the condition they are allocated to. There will be three conditions: intervention, no distraction control, and no strategy control.
In the intervention condition, participants will open reminders related to focusing on the sensory properties of their food while eating their meals. These participants will also have access to a recording that will encourage them to focus on the sensory properties of the food (e.g. its smell, look, texture).
Participants in the no distraction control condition will open reminders related to eating their meals with no distractions. The recording provided to participants in this condition will encourage them to consume their meals with no surrounding distractions (e.g. to avoid watching television or listening to the radio). During the study, the number of times the recording is played as well as the date and time it is played will be recorded.
In the intervention and no distraction control group, at the end of each of the three days participants will also be asked to rate the extent to which they adhered to the strategy they were provided with.
In the no strategy control condition, participants will not receive any reminders to open or have access to a recording.
After the three days (i.e. on a Friday), participants will return to the laboratory. They will be asked to complete a questionnaire regarding the usability of the mobile app and the online food diary. Via this questionnaire, they will also be asked about whether they thought taking part in the study influenced their eating behaviour and the amount of pleasure they got from their food during the three-day period. Additionally they will complete a questionnaire measuring sensitivity to reward. At this session participants will be asked if they are happy to have their weight and height measured. If they are, the researcher will measure their weight and height.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindful eating | Experimental | Behavioral: Mindful eatingParticipants will be encouraged to focus on the sensory properties of their food every time they eat. This will be achieved via an audio recording that they will listen to in the laboratory at their first appointment and that they will have access to over the three-day intervention period. They will also receive a pack of envelopes to open over the intervention period that will also contain reminders to focus on the sensory properties of their food every time they eat. |
| Eating without distractions | Active comparator | Behavioral: Eating without distractionsParticipants will be encouraged to eat their food without distractions every time they eat. This will be achieved via an audio recording that they will listen to in the laboratory at their first appointment and that they will have access to over the three-day intervention period. They will also receive a pack of envelopes to open over the intervention period that will also contain reminders to eat their food without distractions every time they eat. |
| No strategy control | No intervention | –Participants will simply complete the measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluent English speaker
- BMI of 20 to 25 based on reported weight and height
- Access to data or wifi during the evenings
Key exclusion criteria (4 listed)
- Dieting to lose weight
- Taking medication that may affect appetite
- Current or previous diagnosis of an eating disorder
- Completion of related studies
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 |
|---|---|---|
| Mindful eatingAlso: Attentive eatingAttending to the sensory properties of food as it is eaten | Behavioural | Mindful eating |
| Eating without distractionsEating without intentionally attending to something else such as a television, smartphone, computer, book etc | Behavioural | Eating without distractions |
Primary outcome
Calorie intake
Time frame: Three days during intervention delivery
Total calorie intake over three days
4 secondary outcomes
Intake of non milk extrinsic sugars
Time frame: Three days during intervention delivery
Intake of saturated fat
Time frame: Three days during intervention delivery
Fruit and vegetable intake
Time frame: Three days during intervention delivery
Intake of fibre
Time frame: Three days during intervention delivery
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 27 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Diet Modification
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Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
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Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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.
Katy Tapper, PhD principal investigator
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful eating and Eating without distractions in people with Diet Modification, run by City, University of London 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 3 inclusion and 4 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 27 Jan 2020. 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?
Calorie intake (time frame: Three days during intervention delivery). 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 27 Jan 2020.