Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-02 @ 12:50 PM
Study NCT ID:
NCT01616368
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Mindfulness Training on Eating Behaviors and Food Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062407', 'term': 'Meals'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Eating behaviors', 'timeFrame': 'baseline, 2 months, 5 months', 'description': 'The TFEQ will be administered. Subscales for emotional eating, uncontrolled eating and cognitive restraint will be assessed'}], 'secondaryOutcomes': [{'measure': 'Change in Nutrition intake', 'timeFrame': 'baseline, 2 months, 5 months', 'description': 'The ASA-24 and the DHQ will be administered to assess nutritional intake'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Feeding Behavior']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) \\> 26\n\nExclusion Criteria:\n\n* Psychotic disorders\n* Poorly controlled bipolar disorder\n* Borderline or antisocial personality disorder\n* A diagnosed eating disorder'}, 'identificationModule': {'nctId': 'NCT01616368', 'briefTitle': 'The Effects of Mindfulness Training on Eating Behaviors and Food Intake', 'organization': {'class': 'OTHER', 'fullName': 'Seattle Institute for Biomedical and Clinical Research'}, 'officialTitle': 'The Effects of Mindfulness Training on Eating Behaviors and Food Intake', 'orgStudyIdInfo': {'id': 'MIRB 00458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEAL', 'description': 'Participation in an 8-week mindful eating course', 'interventionNames': ['Behavioral: Mindful Eating and Living Course']}], 'interventions': [{'name': 'Mindful Eating and Living Course', 'type': 'BEHAVIORAL', 'otherNames': ['MEAL'], 'description': 'An eight week course designed to teach mindfulness skills with an emphasis on mindful eating.', 'armGroupLabels': ['MEAL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Kearney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seattle Institute for Biomedical and Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seattle Institute for Biomedical and Clinical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Gastroenterology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'David Kearney', 'investigatorAffiliation': 'Seattle Institute for Biomedical and Clinical Research'}}}}