Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 8:37 PM
Study NCT ID:
NCT03131128
Status:
UNKNOWN
Last Update Posted:
2018-03-22
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The researchers will explain the purpose and steps of the study to all the participants and get their informed consent.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The workers with overweight or obesity provided by the company will be randomly assigned to Group A (by MBI) or Group B (by the intervention of health education).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': 'Up to 10 months', 'description': 'Body weight will be recorded during the study carried out.'}], 'secondaryOutcomes': [{'measure': 'Dietary Behavior', 'timeFrame': 'Up to 10 months', 'description': 'Using the Dietary Behavior Questionnaire to measure the intake of types and proportion of food.'}, {'measure': 'Food Cravings', 'timeFrame': 'Up to 10 months', 'description': 'Measuring the level of food cravings, use the Likert six-point scoring method, from 1-6 points, a total of 21 questions. The higher scores indicate higher food cravings levels.'}, {'measure': 'Perceived Stress', 'timeFrame': 'Up to 10 months', 'description': 'Measuring the level of perceived stress, using the Likert five-point scoring method, from 0-4 points, a total of 10 questions .The higher scores indicate higher pressure levels.'}, {'measure': 'The level of Mindfulness', 'timeFrame': 'Up to 10 months', 'description': 'Measuring the level of Mindfulness, using the Likert five-point scoring method, a total of 39 questions, including the five concepts, namely: awareness (8 questions), description (8 questions), non-judging (8 questions), observation (8 questions), and non-reaction (7 questions). The higher scores indicate higher levels of mindfulness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness-based intervention', 'Weight loss', 'Workplace health promotion', 'Obesity'], 'conditions': ['Mindfulness', 'Weight Loss', 'Workplace', 'Health Promotion']}, 'descriptionModule': {'briefSummary': 'The present study will carry out a workplace health promotion via MBI with lessons of dietary behavior to help overweight or obese workers to loss weight.', 'detailedDescription': 'The study will adopt a longitudinal research design with randomized quasi- experimental trial. The workers with overweight or obesity (BMI≧24) provided by the company will be randomly assigned to Group A (four lessons of dietary behavior and six lessons of MBI) or Group B (four lessons of dietary behavior and six lessons of mental health). There will be 100 participants in each group. Data will be collected five times. The research questionnaire includes basic information (including BMI, waist circumference, etc), Perceived Stress Scale, The Five Facet Mindfulness Questionnaire, Food Cravings Questionnaire, the scale of physical activity and information regarding dietary behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adults aged 20 to 65 years old;\n2. full-time workers with BMI ≧ 24;\n3. motivated to participate in the study;\n\nExclusion Criteria:\n\n1. suffering from mental illness or in an acute episode;\n2. suffering from life threatening or other major physical illness;\n3. no motivation to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03131128', 'briefTitle': 'The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'A Pilot Study of the Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss', 'orgStudyIdInfo': {'id': 'ChungShanMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based Intervention', 'description': '2 sessions of diet nutrition education and 6 sessions of Mindfulness-based intervention, 1.5 hours each session.', 'interventionNames': ['Behavioral: Mindfulness-based Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education Intervention', 'description': '2 sessions of diet nutrition education and 6 sessions of Health Education, 1.5 hours each session.', 'interventionNames': ['Behavioral: Health Education Intervention']}], 'interventions': [{'name': 'Mindfulness-based Intervention', 'type': 'BEHAVIORAL', 'description': '1. Keeping mindful when selecting food.\n2. Be aware of hunger and satiety by the body clues.\n3. Understanding how stress affect diet and life, and learn how to cope with stress in life.\n4. Learning to identify overeating caused by mood, social stress and specific food.', 'armGroupLabels': ['Mindfulness-based Intervention']}, {'name': 'Health Education Intervention', 'type': 'BEHAVIORAL', 'description': '1. Identifying improper diet patterns and attitudes\n2. Understanding the impact of irrational cognition and attitudes on dietary behavior\n3. Training coping skills for stresses in real life and preventing the recurrence of bulimia.', 'armGroupLabels': ['Health Education Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shu-Ling Huang, Ph.D', 'role': 'CONTACT', 'email': 'shuling@csmu.edu.tw', 'phone': '+886-2473-0022', 'phoneExt': '12301'}], 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chih-Chun Huang', 'role': 'CONTACT', 'email': 'hilihuang7004@gmail.com', 'phone': '886-930-556128'}, {'name': 'Shu-Ling Huang', 'role': 'CONTACT', 'email': 'shuling@csmu.edu.tw', 'phone': '886-04-24730022', 'phoneExt': '12301'}], 'overallOfficials': [{'name': 'Feng-Cheng Tang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhua Christian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Changhua Christian Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yeh', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}