- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616368
The Effects of Mindfulness Training on Eating Behaviors and Food Intake
November 18, 2014 updated by: David Kearney, Seattle Institute for Biomedical and Clinical Research
The investigators propose to study the effect of mindfulness training on the eating behaviors and dietary intake of overweight or obese persons.
Mindfulness skills training involves bringing non-judgmental attention to thoughts, emotions and bodily sensations - including hunger and satiety cues.
It is hypothesized that as subjects advance through the 8-week class series, developing their capacity for mindfulness and in effect learn to pay attention to the sensations, assumptions, cognitions, and beliefs that underlie their eating behaviors, that their eating behaviors will improve.
Specifically, the investigators hypothesize that 1) there will be significant improvements in the areas of uncontrolled and emotional eating, 2) there will be significant decreases in total caloric intake and significant increases in fruits and vegetables, and 3) there will be a positive significant relationship between the frequency/consistency of mindfulness practice and improvements from baseline to follow-up measures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Early Phase 1
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body Mass Index (BMI) > 26
Exclusion Criteria:
- Psychotic disorders
- Poorly controlled bipolar disorder
- Borderline or antisocial personality disorder
- A diagnosed eating disorder
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MEAL
Participation in an 8-week mindful eating course
|
An eight week course designed to teach mindfulness skills with an emphasis on mindful eating.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Eating behaviors
Time Frame: baseline, 2 months, 5 months
|
The TFEQ will be administered.
Subscales for emotional eating, uncontrolled eating and cognitive restraint will be assessed
|
baseline, 2 months, 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Nutrition intake
Time Frame: baseline, 2 months, 5 months
|
The ASA-24 and the DHQ will be administered to assess nutritional intake
|
baseline, 2 months, 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David Kearney, MD, Seattle Institute for Biomedical and Clinical Research
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
January 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 6, 2012
First Submitted That Met QC Criteria
June 7, 2012
First Posted (Estimate)
June 11, 2012
Study Record Updates
Last Update Posted (Estimate)
November 20, 2014
Last Update Submitted That Met QC Criteria
November 18, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- MIRB 00458
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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