Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT02201069
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
2014-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
My Health Coach Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '12 weeks', 'description': 'stress, fatigue, self-efficacy, motivation'}], 'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Diet quality', 'timeFrame': '12 weeks', 'description': 'adherence to USDA recommendations'}, {'measure': 'Physical activity', 'timeFrame': '12 weeks', 'description': 'adherence to physical activity recommendations of 30 min/day of at least moderate activity.'}, {'measure': 'Sleep', 'timeFrame': '12 weeks', 'description': 'Better sleep habits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nutrition', 'physical activity', 'sleep', 'weight loss'], 'conditions': ['Health Behavior']}, 'descriptionModule': {'briefSummary': 'The "My Health Coach Study" seeks to determine if health coaching by a medical assistant can help patients have better sleep, a better diet, be more physically active or lose weight, according to the recommendation of their health care provider.', 'detailedDescription': 'The aim of the study is to determine whether medical assistants (MAs) can assist primary care providers to achieve healthier lifestyles via better sleep, food choices, weight loss and/or increased physical activity in their patients. The hypothesis driving this research is that health coaching can be done by existing medical support staff to facilitate healthy lifestyles in a primary care setting. Coaching can maximize the health of the patient population in a cost-effective way if the coaching service is integrated into primary care clinics with minimal capital investment at the outset. A major focus will be on behaviors associated with weight management since this is the most common health issue in the U.S. today. This method, if successful, should be easily adaptable to other health behaviors and in most any medical practice that seeks to improve the health of its patient base in a cost-effective way.\n\nIn order to achieve a change in health behaviors, and especially weight loss, regular follow-up contacts are needed. Previous research has shown health coaching to be effective, but this has utilized programs that "add on" to the existing clinic structure. This type of coaching model is difficult to sustain. Utilizing existing staff for health coaching is a method we propose to more fully integrate this service into primary care clinics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults age 21 and over\n* referred by primary care physician for health coaching\n* have telephone for follow-up\n* English speaking\n\nExclusion Criteria:\n\n* pregnant or trying to become pregnant'}, 'identificationModule': {'nctId': 'NCT02201069', 'briefTitle': 'My Health Coach Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'My Health Coach Study', 'orgStudyIdInfo': {'id': 'HUM00087322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'health coaching', 'description': '12 weeks of health coaching using weekly contact in the first month and biweekly contacts in months 2-3.', 'interventionNames': ['Behavioral: health coaching']}], 'interventions': [{'name': 'health coaching', 'type': 'BEHAVIORAL', 'armGroupLabels': ['health coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Briarwood Family Medicine', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Zora Djuric', 'investigatorAffiliation': 'University of Michigan'}}}}