Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT06668259
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D015430', 'term': 'Weight Gain'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Salivary cortisol'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight (kg)', 'timeFrame': '0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks', 'description': 'Weight will be measured using a digital scale in kg to the nearest 0.1 kg.'}, {'measure': 'Physical Activity', 'timeFrame': '0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks', 'description': 'Physical activity will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive days. Accelerometer will only be removed for water-based activities.'}, {'measure': 'Sleep', 'timeFrame': '0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks', 'description': 'Sleep will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive nights.'}, {'measure': 'Stress-related Concepts (EMA)', 'timeFrame': '0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks', 'description': 'Stress-related concepts are measured by surveys of daily coping ability, stress, and affect assessed by Ecological Momentary Assessments (EMA). For daily coping, participants will be asked about their ability to cope with stress, on a scale from 0-10 with 10 indicating completely able to cope. For stress participants will be asked about their current stress level, on a scale from 0-10 with 10 indicating the highest stress. Affect will be assessed through 5 questions related to their current feeling of happiness, frustration, stress, anger, sadness, and calm/relaxed.'}], 'secondaryOutcomes': [{'measure': 'Cortisol (mg/mL)', 'timeFrame': '0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks', 'description': 'Collected via salivary collection methods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress', 'weight loss', 'EMA', 'weight gain', 'cortisol', 'surveys'], 'conditions': ['Individual Stress and Weight Loss']}, 'descriptionModule': {'briefSummary': 'Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who are enrolled in a community-based weight loss program centered in a metropolitan area of a Midwest state will be eligible to participate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in a community-based weight loss program centered in a metropolitan area of a Midwest state. Based on this criteria, we will anticipate participants are greater than 18 years of age, and have obesity.\n* Must own a smart phone and be willing to download the mobile application to receive text messages\n\nExclusion Criteria:\n\n* Report a current medical condition or treatment for a medical condition that could affect body weight.\n* Current psychological condition (including clinically diagnosed depression) that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.\n* Is not fluent in writing or speaking the English language.\n* Mobility limitations so they are unable to perform physical activity.\n* Family member currently enrolled in the study or has a family member that previously participated in the study.'}, 'identificationModule': {'nctId': 'NCT06668259', 'acronym': 'INSTANT', 'briefTitle': 'Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention: INSTANT Study', 'orgStudyIdInfo': {'id': 'STUDY00160436'}, 'secondaryIdInfos': [{'id': '5P20GM144269-03', 'link': 'https://reporter.nih.gov/quickSearch/5P20GM144269-03', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Fairway North', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '66103', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chelsea Kracht', 'role': 'CONTACT', 'email': 'ckracht@kumc.edu', 'phone': '913-588-1655'}, {'name': 'Taylor Gatson', 'role': 'CONTACT', 'email': 'instant@kumc.edu'}], 'facility': 'Kirmayer Fitness Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Chelsea Kracht', 'role': 'CONTACT', 'email': 'ckracht@kumc.edu', 'phone': '913-588-1655'}, {'name': 'Taylor Gatson', 'role': 'CONTACT', 'email': 'instant@kumc.edu'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Beginning 1 year after publication with no end date.', 'ipdSharing': 'YES', 'description': 'Clinical data will be shared with controlled access in NIDDK Central Repository for general research use', 'accessCriteria': 'Data will be stored in the NIDDK Central Repository data repository. Other requests for data and further information can be made to the PI, who will follow appropriate channels to distribute the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chelsea L. Kracht, PhD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}