Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 4:00 PM
Study NCT ID:
NCT07119658
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Successful linkage into outpatient clinic follow-up', 'timeFrame': 'From enrollment to 3 month follow-up', 'description': "Investigators will determine whether intervention patients were able to successfully follow up in the health system's outpatient clinic with the referral provided. This will be determined through review of the electronic medical record."}, {'measure': 'Number of days wearing the Fitbit accelerometer during study period', 'timeFrame': 'From enrollment to 3 month follow-up', 'description': 'Investigators will describe the number of totals days participants actually wore the Fitbit accelerometer device over the study period, allowing for activity data collection.'}, {'measure': 'Demographic data', 'timeFrame': 'This will be collected on Day 1 (i.e. day of screening and approaching for enrollment)', 'description': 'As an additional exploration, we will collect pertinent data on the screening and enrollment process, including demographic data on which patients are screened, approached, and ultimately enrolled. We will ask those who decline enrollment to briefly provide us information (i.e. short-form, open-ended response) on why they are declining to participate, to gain further knowledge on the targeted ED population for this intervention.'}, {'measure': 'Semi-structured interview data', 'timeFrame': 'At 3-month follow-up (for those in intervention group)', 'description': "To better understand reasons for failure and success of adherence to the composite intervention, we will also conduct semi-structured interviews at three-month follow-up of patients in the intervention group. Thematic analysis will be performed to identify theoretical constructs, processes, and themes surrounding the patients' experience with the composite intervention."}], 'primaryOutcomes': [{'measure': 'Mean daily steps', 'timeFrame': 'From enrollment to the end of the 3 month study period', 'description': 'Investigators will collect activity data utilizing a Fitbit accelerometer device. The primary outcome will be the mean number of daily steps averaged from 3 months of monitoring, compared between groups.'}], 'secondaryOutcomes': [{'measure': 'Minutes of moderate to vigorous physical activity', 'timeFrame': 'From enrollment to the end of the 3 month study period', 'description': 'Investigators will collect activity data utilizing a Fitbit accelerometer device. As a secondary outcome, investigators will measure and compare minutes of moderate to vigorous physical activity (MVPA), as this metric will incorporate intensity of activity.'}, {'measure': 'Psychometric survey: the Dietary Screener Questionnaire', 'timeFrame': 'At enrollment and 3 month follow-up', 'description': 'Participants will complete the Dietary Screener Questionnaire survey at baseline and 3-months.'}, {'measure': 'Psychometric surveys: International Physical Activity Questionnaire', 'timeFrame': 'At enrollment and 3 month follow-up', 'description': 'Participants will complete the International Physical Activity Questionnaire survey at baseline and 3-months. This is reported on a continuous scale as physical activity metabolic equivalent of task (MET)-min per day or week.'}, {'measure': 'Psychometric surveys: PROMIS General Life Satisfaction -- Short Form 5a', 'timeFrame': 'At enrollment and 3 month follow-up', 'description': 'Participants will complete the NIH PROMIS General Life Satisfaction -- Short Form 5a survey at baseline and 3-months. (min value: 5, max value: 35, higher score = higher life satisfaction)'}, {'measure': 'Psychometric surveys: PROMIS Physical Function -- Short Form 4a', 'timeFrame': 'At enrollment and 3 month follow-up', 'description': 'Participants will complete the NIH PROMIS Physical Function -- Short Form 4a survey at baseline and 3-months. (min value: 4, max value: 20, higher score = higher physical functioning)'}, {'measure': 'Psychometric surveys: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a', 'timeFrame': 'At enrollment and 3 month follow-up', 'description': 'Participants will complete the NIH PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a survey at baseline and 3-months. (min value: 8, max value: 40, higher score = higher self-efficacy)'}, {'measure': 'Number of participants with a repeat visit to the emergency department', 'timeFrame': 'From enrollment to 3 month follow-up', 'description': 'Investigators will assess ED recidivism over the 3-month follow-up period, which will be defined as any repeat visit to the emergency department over the study period. This will be assessed primarily through review of the electronic medical record for any new ED encounter that occurred after initial enrollment date.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'Emergency Department'], 'conditions': ['Hypertension', 'Hyperglycemia', 'Dyslipidemia', 'Metabolic Syndrome', 'Obesity &Amp; Overweight', 'Diabetes', 'Hyperlipidemia', 'Emergency Medicine']}, 'referencesModule': {'references': [{'pmid': '28641836', 'type': 'BACKGROUND', 'citation': 'Sista AK, Klok FA. Late outcomes of pulmonary embolism: The post-PE syndrome. Thromb Res. 2018 Apr;164:157-162. doi: 10.1016/j.thromres.2017.06.017. Epub 2017 Jun 16.'}, {'pmid': '30418471', 'type': 'BACKGROUND', 'citation': 'Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. 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Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to pilot a multifaceted, optimized intervention for metabolic syndrome (MetS) in emergency department patients to establish feasibility. Participants (n=20) will be randomized to intervention or control (usual care). The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device, resources for healthy eating practices, periodic text message reminders, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit. Investigators hypothesize that this approach will change patient understanding and motivation to increase physical activity and healthy eating habits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory adults (18 years of age) presenting to the emergency department setting\n* BMI 30 kg/m2\n* Prior diagnosis of at least one additional comorbid component of metabolic syndrome: hypertension, hyperglycemia, dyslipidemia\n* Clinical plan for discharge\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Pregnant patients\n* Unable to safely ambulate (including patient or family perception of inability to safely ambulate)\n* Lack of access to smart phone\n* Unable or unwilling to wear Fitbit accelerometer device\n* Unable to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT07119658', 'acronym': 'METS', 'briefTitle': 'Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial', 'orgStudyIdInfo': {'id': '25821'}, 'secondaryIdInfos': [{'id': 'RE2022-0000000327', 'type': 'OTHER_GRANT', 'domain': 'Society for Academic Emergency Medicine Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'The composite intervention will include an educational video outlining the adverse effects of metabolic syndrome and the benefit of walking (which patients will watch at time of enrollment in the emergency department), a written exercise "prescription" with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device to track activity, resources for healthy eating practices, periodic text message reminders over the 3 month study period, and an urgent referral to primary care and our health system\'s Healthy Me clinic for follow-up visit.', 'interventionNames': ['Behavioral: Composite intervention to address MetS']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will receive usual care upon discharge from the emergency department. They will be given a Fitbit accelerometer device to wear for the study period to serve as a comparison but will not receive any specific recommendations for active or any additional component of the composite intervention.'}], 'interventions': [{'name': 'Composite intervention to address MetS', 'type': 'BEHAVIORAL', 'description': 'The composite intervention includes six components: 1. All patients will be provided a Fitbit Charge device at ED discharge with instructions to wear on their wrist for study duration. 2. Participants in the intervention group will first watch a brief (\\~5 minute) educational video outlining the adverse effects of MetS and the benefit of walking, via iPad tablet. 3. Participants in the intervention group will also be given accompanying written "exercise prescription" encouraging them to walk 150 minutes per week. 4. Reminder texts encouraging continued walking behavior (i.e. "Remember to get in your steps!") will be sent to the intervention group, at approximate 2-3x/week intervals for the 3-month follow-up period. 5. The intervention group will also be provided written resources for healthy eating practices upon ED discharge. 6. All intervention group participants will receive referrals into primary care clinic and the Eskenazi Health "Healthy Me" Program for follow-up.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shuhei Misawa, BS', 'role': 'CONTACT', 'email': 'smisawa@iu.edu', 'phone': '3172783919'}, {'name': 'Lauren Stewart, MD', 'role': 'CONTACT', 'phone': '317 880 3900'}, {'name': 'Lauren Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sidney & Lois Eskenazi Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society for Academic Emergency Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Emergency Medicine', 'investigatorFullName': 'Lauren Stewart', 'investigatorAffiliation': 'Indiana University'}}}}