[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466406":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":39,"centralContacts":48,"locations":58,"responsibleParty":80,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":52,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":52,"enrollmentInfo":97,"targetDuration":52,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":61,"whyStopped":52,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Columbia University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Sedentary Break Condition > Control Condition","EXPERIMENTAL","Participants will be assigned to the sedentary break or control condition at each lab visit. If assigned to the sedentary break condition at lab visit 1, participants will be assigned to the control condition at visit 2 (and vice versa). During the lab visit, participants will wear a heart rate monitor and ambulatory blood pressure monitor, and eat a controlled diet. Participants will also eat a controlled diet for two days prior to the lab visit.",[13,14,15],"Behavioral: Sedentary Break (Walking) Condition","Behavioral: Sitting (Control) Condition","Behavioral: Controlled Diet",{"label":17,"type":10,"description":11,"interventionNames":18},"Control Condition > Sedentary Break Condition",[13,14,15],[20,27,33],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Sedentary Break (Walking) Condition","For the sedentary break (walking) condition, participants will be randomized to 1 of 25 combinations of frequency (5 doses: sedentary break every 30, 45, 60, 90, or 120 minutes) and duration (5 doses: sedentary break duration of 1, 3, 5, 7, or 10 minutes). Participants will complete a 9-hour study visit and will remain seated throughout the lab visit and will take regular sedentary breaks by walking on a treadmill at 2.0 mph and 0% incline at specific frequency and duration (as determined by the randomization method) for the entirety of the visit.",[17,9],[26],"Sedentary Break (Walking) Condition - Experimental",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Sitting (Control) Condition","While completing the sitting (control) condition, participants will complete the 9-hour study visit by remaining seated and only standing up\u002Fwalking to use the restroom at specified times.",[17,9],[32],"Sitting (Control) Condition - Shame Comparator",{"type":21,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Controlled Diet","Participants in both the experimental and control groups will eat a controlled diet (breakfast, lunch, dinner, snacks) for two full days before each lab visit. They will also eat a controlled diet (breakfast, lunch) during each of the two lab visits. Participants will choose 1 of 3 dietary menus to eat for the study duration. Each meal will be individualized to meet 33% of daily estimated energy requirements. Target macronutrient profile will be 12-15% energy from protein, 55-58% from carbohydrate and 29-31% from fat; as well as 55 mmol of sodium and 24 mmol of potassium.",[17,9],[38],"Controlled Foods Diet",[40,44],{"name":41,"affiliation":42,"role":43},"Keith Diaz, PhD","Florence Irving Assistant Professor of Behavioral Medicine, CUIMC","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":47},"Ying Kuen (Ken) Cheung, PhD","Professor of Biostatistics, Department of Biostatistics, CUIMC","STUDY_CHAIR",[49,54],{"name":41,"role":50,"phone":51,"phoneExt":52,"email":53},"CONTACT","212-305-1170",null,"kd2442@cumc.columbia.edu",{"name":55,"role":50,"phone":56,"phoneExt":52,"email":57},"Maria Serafini, BS","347-213-0907","cbch_break2study@cumc.columbia.edu",[59],{"facility":60,"status":61,"city":62,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Center for Behavioral Cardiovascular Health","RECRUITING","New York","10032","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-74.00597,40.71427,{"lat":70,"lon":69},[73,74,75,78],{"name":55,"role":50,"phone":56,"phoneExt":52,"email":57},{"name":41,"role":43,"phone":52,"phoneExt":52,"email":52},{"name":76,"role":77,"phone":52,"phoneExt":52,"email":52},"Daichi Shimbo, MD","SUB_INVESTIGATOR",{"name":79,"role":77,"phone":52,"phoneExt":52,"email":52},"Henry Ginsberg, MD",{"type":43,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Keith Diaz","Associate Professor of Behavioral Medicine",[84],{"name":85,"class":86},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100466406","breaking-up-prolonged-sedentary-behavior-to-improve-cardiometabolic-health-100466406",false,"NCT05353322","Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health","Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health: An Adaptive Dose-Finding Study","Inclusion Criteria:\n\n* 18 years of age or older\n* Ability to read, write and speak English or Spanish\n* Limited or no chronic medical conditions \\[examples include but not limited to: CVD, diabetes, chronic obstructive pulmonary disease (COPD), HIV\u002FAIDS; participants with high blood pressure\u002Fhypertension and\u002For high cholesterol\u002Fhyperlipidemia may be included if they are currently prescribed and taking medication for these conditions\\]\n* Do not take medication (over-the-counter or herbal) to control glucose (such as a diabetes control medication)\n* Not currently pregnant\n* Do not currently smoke cigarettes\n* No pre-existing musculoskeletal conditions (including but not limited to osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis) that would prevent participation in intermittent physical activity\n* No allergies to common food allergens including wheat, eggs, milk or other dairy, gluten, fructose, peanuts or other nuts\n* No dietary restrictions such as vegan, gluten free, halal\n\nExclusion Criteria:\n\n• Unable to provide consent",true,"ALL","18 Years",{"count":98,"type":99},324,"ESTIMATED","INTERVENTIONAL",[102],"NA","The purpose of this Phase 1 research study is to answer two questions: (1) How frequent should periods of prolonged sedentary time be interrupted? and (2) What is the appropriate duration or length of time of these breaks in sedentary time? To address these questions, this project will conduct a state-of-the-art adaptive dose finding study under controlled laboratory conditions to determine the minimally effective dose (the smallest dose) that yields cardiometabolic benefit for two separate sedentary break elements (frequency and duration). Study findings will ultimately determine how often and for how long people should break up periods of prolonged sedentary time to transiently improve established cardiovascular risk factors; key foundational information critical to the success of future long-term trials and ultimately public health guidelines.\n\nPrimary Aim: To determine the minimally effective dose combination(s) of frequency and duration needed to provide cardiometabolic benefit during an 8-hour experimentation period. Specifically, the study will determine:\n\n1a. For each fixed duration, the minimum sedentary break frequency (e.g., every 30 min, 60 min, 120 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control condition.\n\n1b. For each fixed frequency, the minimum sedentary break duration (e.g., activity breaks of 1 min, 5 min, 10 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control.\n\nSecondary Aim: It is also critical to public health strategy to assess the acceptability\u002Ffeasibility of various sedentary break doses as too high a dose will yield poor uptake. To address this need, the maximally tolerated dose (the highest dose that does not cause undue physical\u002Fpsychological distress) for frequency and duration of sedentary breaks will also be determined via assessment of 4 constructs: physical exhaustion\u002Ffatigue, affect (e.g., mood, emotion), tolerability (e.g., completion of dose protocol), and safety (e.g., hypoglycemia). Maximally tolerated dose will be defined as the highest dose where \\\u003C20% of participants exhibit an adverse outcome.",[105,106,107,108],"Sedentary Behavior","Cardiometabolic Risk Factors","Blood Pressure","Glucose",[105,110,107,108,111,112],"Physical Activity","Insulin","Dose-finding","2026-04-06",{"date":115,"type":116},"2026-04-09","ACTUAL",{"date":118,"type":116},"2022-06-30",{"date":120,"type":99},"2028-03-31",{"name":5,"class":6},1]