The Effects of Mindfulness Training on Eating Behaviors and Food Intake
| Tracking Information | |||||
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| First Received Date ICMJE | June 6, 2012 | ||||
| Last Updated Date | June 7, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Eating behaviors [ Time Frame: baseline, 2 months, 5 months ] [ Designated as safety issue: No ] The TFEQ will be administered. Subscales for emotional eating, uncontrolled eating and cognitive restraint will be assessed |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01616368 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Change in Nutrition intake [ Time Frame: baseline, 2 months, 5 months ] [ Designated as safety issue: No ] The ASA-24 and the DHQ will be administered to assess nutritional intake |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Mindfulness Training on Eating Behaviors and Food Intake | ||||
| Official Title ICMJE | The Effects of Mindfulness Training on Eating Behaviors and Food Intake | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Mindful Eating and Living Course
An eight week course designed to teach mindfulness skills with an emphasis on mindful eating.
Other Name: MEAL |
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| Study Arm (s) | Experimental: MEAL
Participation in an 8-week mindful eating course
Intervention: Behavioral: Mindful Eating and Living Course |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 19 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01616368 | ||||
| Other Study ID Numbers ICMJE | MIRB 00458 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David Kearney, Seattle Institute for Biomedical and Clinical Research | ||||
| Study Sponsor ICMJE | Seattle Institute for Biomedical and Clinical Research | ||||
| Collaborators ICMJE | American College of Gastroenterology | ||||
| Investigators ICMJE |
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| Information Provided By | Seattle Institute for Biomedical and Clinical Research | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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