[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659252":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":39,"overallOfficials":45,"centralContacts":50,"locations":56,"responsibleParty":73,"collaborators":24,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":58,"whyStopped":24,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Sleep Self-Efficacy From Baseline to 12 Weeks","Sleep self-efficacy will be assessed using the 9-item Sleep Self-Efficacy Scale. Each item is rated on a 5-point scale from 1 (not confident at all) to 5 (very confident) and summed to produce a total score ranging from 9 - 45. Higher scores indicate greater confidence in performing sleep-related behaviors. (Scoring: sum the 9 items: possible total = 9 - 45, higher = greater sleep self-efficacy.) The outcome will be the change in Sleep Self-Efficacy Scale score from baseline to 12 weeks.","From baseline to 12 weeks.",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Change in Sleep Action Planning From Baseline to 12 Weeks","Sleep action planning will be assessed using the 5-item Sleep Action Planning Scale. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The mean of the five items is calculated, producing a score ranging from 1 to 5, with higher scores indicating stronger action planning for healthy sleep behaviors. The outcome will be the change in mean score from baseline to 12 weeks.","From baseline to 12 weeks",{"measure":19,"description":20,"timeFrame":12},"Change in Sleep Coping Planning From Baseline to 12 Weeks","Sleep coping planning will be assessed using the 5-item Sleep Coping Planning Scale. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The mean of the five items is calculated, producing a score ranging from 1 to 5, with higher scores indicating stronger planning for managing barriers to healthy sleep. The outcome will be the change in mean score from baseline to 12 weeks.",{"measure":22,"description":23,"timeFrame":12},"Change in PROMIS Sleep Disturbance Score From Baseline to 12 Weeks","Sleep disturbance will be assessed using the PROMIS Sleep Disturbance Short Form 8a, an 8-item self-report measure assessing sleep quality and sleep-related difficulties during the past 7 days. Item responses are summed and converted to standardized PROMIS T-scores, with higher scores indicating greater sleep disturbance. The outcome will be the change in PROMIS Sleep Disturbance score from baseline to 12 weeks.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","HEALTH_SERVICES_RESEARCH",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","Sleep disruption is a common and modifiable behavioral risk factor associated with hypertension, impaired glucose regulation, systemic inflammation, cognitive dysfunction, and cardiovascular disease. Poor sleep is highly prevalent in the Southeastern United States, where rates of cardiometabolic disease and cognitive decline are disproportionately high. Despite growing recognition of sleep as a core component of cardiovascular and brain health, sleep health is rarely addressed in routine primary care beyond general sleep hygiene recommendations. Adults with elevated cardiometabolic risk often experience competing demands, chronic stress, and multiple comorbidities that make sustained sleep behavior change difficult. Low-cost, scalable behavioral sleep programs that can be integrated into primary care settings are needed. This study will provide preliminary data needed to inform future larger-scale behavioral sleep studies and implementation focused research in high-risk primary care populations.",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"Sleep behavioral program","EXPERIMENTAL","The 12-week sleep behavioral program consists of: Seven structured sleep coaching sessions by telephone; Brief weekly check-in questionnaire received by text message; and Weekly automated one-way text messaging support.",[38],"Behavioral: Sleep Better, Live Better",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":24},"BEHAVIORAL","Sleep Better, Live Better","Sleep program designed to target modifiable behavioral processes underlying sleep health, including action planning, coping planning, and self-efficacy, to support behavioral change. Participants select one or two sleep behavioral targets to improve and then over 12 weeks, complete seven structured sleep coaching sessions by telephone, complete brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.",[34],[46],{"name":47,"affiliation":48,"role":49},"Ronald M Lazar, PhD","University of Alabama at Birmingham (UAB)","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":24,"email":55},"Catherine D Jones, PhD, MSPH","CONTACT","205-975-7307","catherinejones@uabmc.edu",[57],{"facility":48,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-86.80249,33.52066,{"lat":68,"lon":67},[71,72],{"name":52,"role":53,"phone":54,"phoneExt":24,"email":55},{"name":47,"role":49,"phone":24,"phoneExt":24,"email":24},{"type":49,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Ronald M. Lazar, PhD","Evelyn F. McKnight Endowed Chair, Professor of Neurology and Neurobiology, Director - Division of Neuropsychology, Director - Evelyn F. McKnight Brain Institute at UAB","100659252","sleep-better-live-better-study-100659252",false,"NCT07862348","Sleep Better, Live Better Study","A Feasibility Study of the Sleep Better, Live Better Program in a Primary Care-Recruited Population [Sleep Better, Live Better (SBLB) Study]","SBLB","Inclusion Criteria:\n\n1. Adults ages 25-65;\n2. Self-reported sleep duration \\\u003C7 hours per night;\n3. Elevated cardiometabolic risk, i.e., presence of one or more of the following - hypertension, obesity, hyperlipidemia, diabetes;\n4. Sleep is a behavioral target that individual wants to improve;\n5. Complete eligibility screening procedures: Insomnia Severity Index (ISI-7), STOP-BANG, Epworth Sleepiness Scale (ESS);\n6. Access to a smartphone, capable of receiving text messages and text links;\n7. Able to speak and read English;\n8. Willing and able to provide informed consent and participate in all study procedures\n\nExclusion Criteria:\n\n1. Exceeds eligibility screening thresholds: ISI-7 score ≥22, STOP-BANG score ≥5, ESS score ≥11;\n2. Unable to complete study procedures in English;\n3. No access to mobile phone with text messaging features;\n4. Pregnancy","ALL","25 Years","65 Years",{"count":88,"type":89},25,"ESTIMATED","INTERVENTIONAL",[26],"The goal of this clinical trial is to determine the effects of a 12-week sleep behavioral program for adults ages 25-65 with poor sleep and elevated cardiometabolic risk. The main questions it aims to answer are: To evaluate the feasibility of recruitment, enrollment, retention, and data collection; program fidelity; and participant engagement with coaching sessions, text messages, and weekly check-ins; and to assess preliminary pre-post program changes in participant self-reported sleep, sleep self-efficacy, action and coping constructs, and Brain Care Score. Participants will: Complete seven structured sleep coaching sessions by telephone; complete a brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.",[94,95,96,97,98],"Sleep Hygiene","Sleep Duration","Health Behavior","Self Efficacy","Sleep",[100,101,102,94,103,104],"Modifiable behaviors","Brain Health","Sleep Health","Health Action Process Approach","Primary Care","2026-10-01",{"date":107,"type":108},"2026-10-07","ACTUAL",{"date":105,"type":89},{"date":111,"type":89},"2027-07-31",{"name":5,"class":6},1]