- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601650
The Effect of Mindful Eating on Calorie Intake and Diet
The Effect of Mindful Eating on Calorie Intake and Diet Over a 3-day Period Among Healthy Weight Women.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, EC1R 0JD
- City, University of London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fluent English speaker
- BMI of 20 to 25 based on reported weight and height
- Access to data or wifi during the evenings
Exclusion Criteria:
- Dieting to lose weight
- Taking medication that may affect appetite
- Current or previous diagnosis of an eating disorder
- Completion of related studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindful eating
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.
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Attending to the sensory properties of food as it is eaten
Other Names:
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Active Comparator: Eating without distractions
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.
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Eating without intentionally attending to something else such as a television, smartphone, computer, book etc
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No Intervention: No strategy control
Participants will simply complete the measures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calorie intake
Time Frame: Three days during intervention delivery
|
Total calorie intake over three days
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Three days during intervention delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intake of non milk extrinsic sugars
Time Frame: Three days during intervention delivery
|
Total intake (in grams) of non milk extrinsic sugars over the three days
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Three days during intervention delivery
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Intake of saturated fat
Time Frame: Three days during intervention delivery
|
Total intake (in grams) of saturated fat over the three days
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Three days during intervention delivery
|
Fruit and vegetable intake
Time Frame: Three days during intervention delivery
|
Total intake (in grams) of fruit and vegetables, excluding juices, smoothies, potatoes and legumes
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Three days during intervention delivery
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Intake of fibre
Time Frame: Three days during intervention delivery
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Total intake (in grams) of fibre (using the Englyst measure)
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Three days during intervention delivery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katy Tapper, PhD, City, University of London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSYETH (R/L) 16/17 92
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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