[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"health-coaching\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:health-coaching":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,88,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100622157","effects-of-wearable-device-functions-and-health-coaching-on-device-measured-movement-behaviours-and-cardiometabolic-risk-factors-in-adults-with-central-obesity-100622157",false,"NCT07379970","Effects of Wearable Device Functions and Health Coaching on Device-measured Movement Behaviours and Cardiometabolic Risk Factors in Adults With Central Obesity","Effects of Wearable Device Functions and Health Coaching on Device-measured Movement Behaviours and Cardiometabolic Risk Factors in Adults With Central Obesity: a Randomised Controlled Trial","Inclusion Criteria:\n\n* Age 40 years or older\n* Central obesity, defined as waist circumference: ≥90 cm for men; ≥80 cm for women\n* Insufficient physical activity based on World Health Organization (WHO) guidelines\n* Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) - Short Form\n* Ownership of a smartphone\n* Able to read and understand English or Chinese\n\nExclusion Criteria:\n\n* unable to perform daily-life activities, based on the Physical Activity Readiness-Questionnaire (PAR-Q) (24) and\u002For participation in another lifestyle-change intervention study.","ALL","40 Years",{"count":19,"type":20},133,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a randomized controlled trial. The objective of this study is to investigate:\n\n1. the effects of 1-year evidence-based interventions incorporating wearable device functions alone on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity; and\n2. the effects of 1-year evidence-based interventions incorporating wearable device functions combined with health coaching on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity.\n\nWe hypothesise that the use of wearable device functions in combination with health coaching will lead to significantly greater improvements in device-measured movement behaviours and cardiometabolic risk factors compared with no intervention and wearable device functions alone, both after the 12-month intervention and at the 6-month follow-up.\n\nThis study will implement a parallel-group, open-label, 1-year randomized controlled trial involving 133 adults aged 40 years or older with central obesity. The trial will examine the effects of a cutting-edge intervention using evidence-based wearable device functions alone or in combination with evidence-based health coaching on movement behaviours and cardiometabolic risk factors.\n\nAll participants will provide written informed consent prior to participation and will be informed that they may withdraw from the study at any time during the study period. A staff member without access to participant information will generate a computer-based randomization list using permuted blocks of six, with two participants allocated to each of the three groups (two intervention groups and one control group) per block, in a 2:2:2 allocation ratio.\n\nThe control group will not receive a Fitbit device and will be asked to continue their usual lifestyle. The two intervention groups will use four evidence-based Fitbit functions: step goal setting, sleep goal setting, activity prompts, and community functions. The key difference between the two intervention groups is that one group will additionally receive a structured health coaching program adapted from the U.S. Centers for Disease Control and Prevention (CDC) National Diabetes Prevention Program (NDPP), as used in our prior trial.\n\nThe CDC NDPP recommends that at least 22 health coaching sessions be delivered over a 1-year period, depending on participants' needs, and provides corresponding curricula and handouts outlining session content. Coaching sessions will be delivered by trained research staff who have received appropriate professional training in health coaching delivery.\n\nThe lifestyle change program will include, but not be limited to:\n\n1. education on cardiometabolic disease risk factors (e.g., type 2 diabetes, coronary heart disease, and stroke);\n2. goal planning and goal setting;\n3. strategies for self-monitoring physical activity, sleep, diet, and stress;\n4. strategies for initiating and maintaining favourable levels of physical activity, diet, and sleep;\n5. strategies for obtaining support from family, friends, and co-workers; and\n6. review of achievements and challenges during the intervention period, with goal setting and planning for the subsequent 6-month follow-up period.\n\nParticipants will attend the research laboratory on three occasions: at baseline, immediately after the 12-month intervention, and at the 6-month follow-up. Assessments will include demographic information, standing height, body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio, systolic and diastolic blood pressure, and questionnaires.\n\nAt each laboratory visit, one EDTA blood sample and one clotted blood sample will be collected by a trained phlebotomist and analysed by an accredited medical diagnostic centre to assess cardiometabolic risk markers, including total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.\n\nAn Axivity AX6 device will be used as a research-grade accelerometer to assess movement behaviours, including sleep, sedentary time, light physical activity, moderate-to-vigorous physical activity (MVPA), steps, energy expenditure, and resting heart rate. Participants will also be asked to wear the Axivity device on the dominant wrist for seven consecutive days at baseline and post-intervention.\n\nResearch staff will access participants' Fitbit web accounts to extract Fitbit data, activate Fitbit functions for the intervention groups, and monitor device battery life. Reminders to wear and charge the Fitbit and research-grade accelerometer will be sent every seven days via WhatsApp to promote protocol compliance. To further support adherence, participants who complete all study assessments will receive a HKD 500 supermarket voucher.",[26,27,28,29,30],"Fitness Trackers","Cardio Vascular Disease","Physical Activities","Exercise","Health Coaching",[32,33,34,35],"movement behavior","NDPP Program","randomized controlled trial","wearable technology","RECRUITING","2026-01-23",{"date":39,"type":40},"2026-02-02","ACTUAL",{"date":42,"type":40},"2025-01-01",{"date":44,"type":20},"2027-12-31",{"name":46,"class":47},"The University of Hong Kong","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":75,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":48},"100531998","the-fit-with-us-study-100531998","NCT06207084","The Fit With Us Study","Precision-based Teleexercise Trial to Increase Adherence in People With Disabilities","FITWITHUS","Eligible participants must meet the following criteria to be included: (1) live with a permanent physical disability that limits their mobility; (2) be 18 to 89 years of age; (3) have broadband internet access; (4) be able to speak and read English; and (5) be able to attend coaching and training sessions during the weekdays.\n\nParticipants are excluded from participation if they (1) possess significant visual acuity that prevents seeing a computer screen to follow a home exercise program; (2) have been regularly engaging in exercise for the previous 3 months; (3) are unable to use their arms and their legs at all to exercise; (4) are unsafe to exercise; (5) self-report that they are currently pregnant","18 Years","89 Years",{"count":60,"type":20},257,[23],"The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.",[64,65,66,30,67,68,69,70,71,72,73,74],"Mobility Limitations","Disability Physical","Telehealth","Physical Activity","Behavior, Health","eHealth","Health Literacy","Self Efficacy","Fatigue","Usability","Predictive Model",[76,77,78],"telehealth","health coaching","disability","2026-01-07",{"date":81,"type":40},"2026-01-09",{"date":83,"type":40},"2024-09-01",{"date":85,"type":20},"2029-02-01",{"name":87,"class":47},"University of Alabama at Birmingham",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":48},"100601522","personalized-health-coaching-for-patients-with-hf-100601522","NCT07111585","Personalized Health Coaching for Patients With HF","Effect of Personalized Health Coaching Program in Patients With Frailty and Heart Failure","Coach-FrailHF","Inclusion Criteria:\n\n* Participants aged 40 years or older will be included in the study, as heart failure (HF)-related mortality and the prevalence of HF increase significantly from this age onward. Inclusion criteria requires a diagnosis of acute HF by a cardiologist and hospitalization based on the following criteria: presence of HF symptoms (e.g., breathlessness, fatigue, ankle swelling) and signs (e.g., elevated jugular venous pressure, pulmonary crackles, peripheral edema), evidence of pulmonary congestion or edema on chest X-ray, and elevated levels of BNP (≥100 pg\u002FmL) or NT-proBNP (≥300 pg\u002FmL). After initial screening for frailty using both the Tilburg Frailty Indicator (TFI) and Fried's Phenotype (FP), participants will be enrolled if they are classified as frail, able to cooperate with functional assessments, and willing to provide written informed consent with a clear understanding of the study's purpose and procedures.\n\nExclusion Criteria:\n\n* The exclusion criteria were as follows: current enrollment in other programs or planning to participate in similar programs during the intervention period; residing outside Korea and not understanding Korean; diagnosis of dementia with the Global Deterioration Scale stage of 5 or greater; inability to comprehend the study purpose and content.",{"count":97,"type":20},80,[23],"Frailty in heart failure (HF) patients contributes to poor outcomes, emphasizing the need for effective management. In many previous studies, frailty interventions have mainly targeted physical frailty or focused community-dwelling patients, neglecting the multidimensional needs of hospitalized individuals. As a frailty for HF patients need to include clinical, functional, cognitive, and social domains, nurses must assess it holistically and provide personalized support, especially during care transitions. This study aims to evaluate the effectiveness of a nurse-led, personalized health coaching program for hospitalized HF patients with frailty through a randomized controlled trial. This 12-week intervention program targets hospitalized HF patients with frailty. After screening frailty HF patients using validated tools such as Fried's phenotype (FP), Tilburg Frailty Indicator (TFI), participants will be randomly assigned to either an intervention or control group. The intervention group will receive personalized health services, including pre-discharge education and weekly telephone coaching, addressing clinical, functional, psycho-cognitive, and social frailty domains. Psychiatric support and community integration program will be provided as needed. The control group will receive standard care. Frailty, QoL, and clinical outcomes will be measured at baseline, 12 weeks, and 24 weeks. The primary outcomes will be improvements in frailty and QoL. Frailty will be measured both multidimensional and each of the four domains of frailty for HF patients. This study will clarify the role of multidimensional personalized interventions in addressing adverse outcomes related to frailty in patients with HF, thereby providing evidence of their necessity in its management.",[101,102,30,103,104,105],"Heart Failure","Frailty","Telenursing","Patient Monitoring","Randomized Controlled Trial","2025-08-07",{"date":108,"type":40},"2025-08-08",{"date":110,"type":40},"2025-07-03",{"date":112,"type":20},"2027-06",{"name":114,"class":47},"Gachon University Gil Medical Center",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":137,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":48},"100585834","preventative-screening-and-health-coaching-in-a-food-insecure-population-100585834","NCT06907524","Preventative Screening and Health Coaching in a Food Insecure Population","Community-Based Preventative Cardiometabolic Screening and Health Coaching- A Prospective Study","HEALTHCOACH","Inclusion:\n\nPatient is a participant at a CHI sponsored, community screening event Patient provides informed consent and willingness to participate for the duration of the study English or Spanish speaking Age 40-75 years old At least 1 cardiometabolic risk factor at suboptimal level\n\nDefined as one or more of the following at initial screening:\n\nBlood Pressure (BP):\n\nSystolic BP greater than 130mmHg and\u002For diastolic BP greater than 80mmHg. Obesity: body mass index (BMI) greater than 30 〖kg\u002Fm〗\\^2\n\nDyslipidemia:\n\nTotal cholesterol greater than 200 mg\u002FdL Triglycerides greater than 150 mg\u002FdL Low density lipoprotein (LDL) greater than 130 mg\u002FdL High density lipoprotein (HDL) less than 40 mg\u002FdL in men or less than 50 mg\u002FdL in women Hemoglobin A1c greater than or equal to 5.7% 10-year ASCVD score greater than 5% Access to a telehealth compatible device\n\nExclusion:\n\nAdults unable to provide informed consent or unwilling to participate for study duration Speaks language other than English or Spanish Younger than 40 years old or older than 75 years old All cardiometabolic risk factors at optimal levels No telehealth compatible device Pregnant patients","75 Years",{"count":125,"type":20},200,[23],"The goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are:\n\n* Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke?\n* Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes?\n* Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare?\n\nResearchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors.\n\nParticipants will:\n\n* Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6.\n* Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare\n* Keep a log of their blood pressure",[129,130,131,132,133,134,135,136,30],"Cardiovascular Disease Prevention","Cardiometabolic Diseases","Cardiovascular Risk Factor","Cardiovascular Risk Score","Hypertension","Hyperlipidemia","Diabetes","Lifestyle Modification",[129,138,133,134,135,136,30,132,139,131,140],"Cardiometabolic Disease Screening","Atherosclerotic Cardiovascular Disease Risk Score","Cardiometabolic Disease","NOT_YET_RECRUITING","2025-03-26",{"date":144,"type":40},"2025-04-02",{"date":146,"type":20},"2025-04-01",{"date":148,"type":20},"2027-07-01",{"name":150,"class":47},"Rush University Medical Center"]