MindfulnessNCT03573440
The Effects of Mindful Eating Education on Increasing Satiety Signals
A study testing mindful education on eating in people with Mindfulness, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this graduate student research study is to is to examine the effects of mindful eating education on increasing satiety signals. Reasons for conducting the study: Add to the body of knowledge on the science of mindful eating. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- mindful education on eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 31 May 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- currently enrolled at Loma Linda University
- pack or purchase their own lunch on a regular basis (willingness bring/buy the same lunch the following week)
- have a 1 hour or less lunch period.
Who cannot join
- skip breakfast
- have exercised within 2 hours of their lunch time
- smoke nicotine or marijuana
- have the condition of Type 1 or Type 2 diabetes
- have newly prescribed medications 2 weeks prior to testing.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this graduate student research study is to is to examine the effects of mindful eating education on increasing satiety signals.
Reasons for conducting the study: Add to the body of knowledge on the science of mindful eating.
Read the detailed description
The procedures include:
Visit 1:
- The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion, sign an informed consent form, sign in, and provide an email address and phone number.
- After the initial briefing, the subject will be asked to eat their meal with an investigator present.
- The subject will inform the investigator verbally when they are feeling full.
- After the subject decides to end their meal, the subject will be asked to fill out a questionnaire and be reminded to bring the same meal the following week.
Visit 2:
- The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion with the same meal as the previous week.
- After receiving a brief education session, the subject will be asked to eat their meal with an investigator present.
- The subject must inform the investigator verbally when they are feeling full.
- After the subject has decided to end their meal, they will be asked to fill out a questionnaire and be reminded to meet the investigator at the same time the following week.
Visit 3:
- The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion.
- The subject will be asked to complete a follow-up survey on the study.
- Conditions
- Mindfulness
- Being tested
- mindful education on eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindful education on eatingOther
Mindful eating education material: mindful eating handout by move.va.gov. It includes topics such as: observe your body, do not judge yourself, notice your reaction to food and savor your food.
| Study group | Role | What they receive |
|---|---|---|
| no mindful eating education | No intervention | * Subject will be asked to eat their meal with an investigator present. * They will inform the investigator verbally when they are feeling full. * After they have decided to end their meal, they will be asked to fill out a questionnaire |
| mindful eating education | Experimental | * After receiving a brief education session on mindful eating, subject will be asked to eat their meal with an investigator present.
* They will inform the investigator verbally when they are feeling full.
* After they have decided to end their meal, they will be asked to fill out a questionnaire Receives: Other: mindful education on eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in satiety
The subject will be asked to verbally inform the investigator when they feel full. The investigator will be using a stopwatch to record when the subject has reached satiety.
Measured: change from baseline to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Jul 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Hodgkin, EdD, Loma Linda University
- Investigators
- Georgia Hodgkin, EdD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573440
- Sponsor's protocol ID
- 5180174
- Status last verified
- Sep 2019
- First submitted
- 7 Jun 2018
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindful Eating Education on Increasing Satiety Signals
- ClinicalTrials.gov ID
- NCT03573440
- Acronym / sponsor ID
- 5180174
- Conditions
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 29 Jun 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 purpose of this graduate student research study is to is to examine the effects of mindful eating education on increasing satiety signals.
Reasons for conducting the study: Add to the body of knowledge on the science of mindful eating.
Detailed description
The procedures include:
Visit 1:
- The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion, sign an informed consent form, sign in, and provide an email address and phone number.
- After the initial briefing, the subject will be asked to eat their meal with an investigator present.
- The subject will inform the investigator verbally when they are feeling full.
- After the subject decides to end their meal, the subject will be asked to fill out a questionnaire and be reminded to bring the same meal the following week.
Visit 2:
- The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion with the same meal as the previous week.
- After receiving a brief education session, the subject will be asked to eat their meal with an investigator present.
- The subject must inform the investigator verbally when they are feeling full.
- After the subject has decided to end their meal, they will be asked to fill out a questionnaire and be reminded to meet the investigator at the same time the following week.
Visit 3:
- The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion.
- The subject will be asked to complete a follow-up survey on the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no mindful eating education | No intervention | –* Subject will be asked to eat their meal with an investigator present. * They will inform the investigator verbally when they are feeling full. * After they have decided to end their meal, they will be asked to fill out a questionnaire |
| mindful eating education | Experimental | Other: mindful education on eating* After receiving a brief education session on mindful eating, subject will be asked to eat their meal with an investigator present. * They will inform the investigator verbally when they are feeling full. * After they have decided to end their meal, they will be asked to fill out a questionnaire |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- currently enrolled at Loma Linda University
- pack or purchase their own lunch on a regular basis (willingness bring/buy the same lunch the following week)
- have a 1 hour or less lunch period.
Key exclusion criteria (5 listed)
- skip breakfast
- have exercised within 2 hours of their lunch time
- smoke nicotine or marijuana
- have the condition of Type 1 or Type 2 diabetes
- have newly prescribed medications 2 weeks prior to testing.
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 education on eatingMindful eating education material: mindful eating handout by move.va.gov. It includes topics such as: observe your body, do not judge yourself, notice your reaction to food and savor your food. | Other | mindful eating education |
Primary outcome
Change in satiety
Time frame: change from baseline to one week
The subject will be asked to verbally inform the investigator when they feel full. The investigator will be using a stopwatch to record when the subject has reached satiety.
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 9 Sep 2019.
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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.
Georgia Hodgkin, EdD principal investigator
Loma Linda 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 mindful education on eating in people with Mindfulness, run by Loma Linda University at 1 site in United States.
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 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 9 Sep 2019. 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 States. 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 satiety (time frame: change from baseline to one week). 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 9 Sep 2019.