- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03573440
The Effects of Mindful Eating Education on Increasing Satiety Signals
September 5, 2019 updated by: Georgia Hodgkin, EdD, Loma Linda University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda Universtiy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: no mindful eating education
|
|
|
Experimental: mindful eating education
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
change from baseline to one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georgia Hodgkin, EdD, Loma Linda University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
June 7, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 29, 2018
Study Record Updates
Last Update Posted (Actual)
September 9, 2019
Last Update Submitted That Met QC Criteria
September 5, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 5180174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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