Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-23 @ 8:21 AM
Study NCT ID:
NCT01796834
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2013-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Diabetes Mindfully Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2013-02-20', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measures of diabetes self-management', 'timeFrame': 'At baseline and 0 - 3 weeks after completion of the intervention', 'description': 'By self report (survey)'}, {'measure': 'Measure of perceived stress', 'timeFrame': 'At baseline and 0 - 3 weeks after completion of the intervention', 'description': 'By self report (survey)'}, {'measure': 'Measure of depression', 'timeFrame': 'At baseline and 0 - 3 weeks after completion of the intervention', 'description': 'By self report (survey)'}, {'measure': 'Measure of self-efficacy', 'timeFrame': 'At baseline and 0 - 3 weeks after completion of the intervention', 'description': 'By self report (survey)'}, {'measure': 'Measure of quality of life', 'timeFrame': 'At baseline and 0 - 3 weeks after completion of the intervention', 'description': 'By self report (survey)'}, {'measure': 'patient evaluation of MBSR intervention', 'timeFrame': 'week 12- 15 post baseline measures', 'description': 'semi-structured telephone interviews with subjects evaluating their perception of the value of the intervention on their overall diabetes management; their satisfaction with the intervention; and their perception of the intervention impact on their quality of life'}], 'primaryOutcomes': [{'measure': 'HbA1C Blood Test', 'timeFrame': 'Baseline and 12-15 weeks from start of intervention period', 'description': 'This HbA1C blood test will be compared to a qualifying HbA1C blood test.'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '8 weeks during intervention', 'description': 'Subjects will self-administer blood pressure testing with a wrist blood pressure cuff and a Daily Log provided to the subject and record results during the intervention period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mindfulness-Based Stress Reduction', 'Diabetes Management', 'Stress Reduction', 'Diabetes Testing'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29064772', 'type': 'DERIVED', 'citation': 'Whitebird RR, Kreitzer MJ, Vazquez-Benitez G, Enstad CJ. Reducing diabetes distress and improving self-management with mindfulness. Soc Work Health Care. 2018 Jan;57(1):48-65. doi: 10.1080/00981389.2017.1388898. Epub 2017 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life; and to estimate the effect of a MBSR program for patients with DM. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.', 'detailedDescription': 'Primary Objective: Evaluate the feasibility of conducting a trial of a MBSR program for patients with diabetes on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life. Feasibility will be assessed via: a) the interest of patients in taking part in an MBSR program; c) the effectiveness of strategies for recruiting patients with diabetes into the study; d) rates of participant compliance with the MBSR; and, e) patient compliance with the program evaluation plan.\n\nEstimate the effect of a MBSR program for patients with diabetes. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.\n\nSecondary Objective: To explore the experience of people with diabetes who participate in an MBSR course through the use of semi-structured interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years of age\n* English speaking\n* have type 2 diabetes, with 2 HbA1C values \\>8 in prior 16 months\n* HbA1C value of \\>8 within 3 months of intervention start\n* able to read course materials\n* mentally intact with no history of mental illness or major depression\n* reachable by phone (for phone support component)\n* able to attend weekly classes\n* willing to provide written informed consent\n\nExclusion Criteria:\n\n* completed formal training in other mind body practices such as meditation, yoga, or tai chi within the prior year or currently have a regular ongoing practice in this area.'}, 'identificationModule': {'nctId': 'NCT01796834', 'acronym': 'MDM', 'briefTitle': 'Managing Diabetes Mindfully Study', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Managing Diabetes Mindfully Study', 'orgStudyIdInfo': {'id': 'K23AT003919-01A2', 'link': 'https://reporter.nih.gov/quickSearch/K23AT003919-01A2', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23AT003919-01A2', 'link': 'https://reporter.nih.gov/quickSearch/K23AT003919-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-Based Stress Reduction', 'description': 'Subjects attend a community based Mindfulness-Based Stress Reduction course.', 'interventionNames': ['Behavioral: Mindfulness-Based Stress Reduction (MBSR)']}], 'interventions': [{'name': 'Mindfulness-Based Stress Reduction (MBSR)', 'type': 'BEHAVIORAL', 'description': 'An 8-9 week MBSR course led by an experienced instructor in a group format. Participants learn mindfulness meditation techniques and simple yoga exercises. Subjects receive four phone support calls.', 'armGroupLabels': ['Mindfulness-Based Stress Reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55425', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Institute for Education and Research', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}], 'overallOfficials': [{'name': 'Robin Whitebird, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}