[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653597":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":48,"overallOfficials":32,"centralContacts":53,"locations":63,"responsibleParty":84,"collaborators":87,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":32,"studyType":106,"phases":107,"briefSummary":108,"conditions":109,"keywords":117,"overallStatus":123,"whyStopped":32,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Louisiana State University and A&M College","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":32},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Number of adults screened (Participants)","Number of adults screened for eligibility for the study","Weekly throughout recruitment",{"measure":14,"description":15,"timeFrame":16},"Intervention Acceptability (CSQ-8)","Acceptability will be assessed using the Client Satisfaction Questionnaire-8 (CSQ-8). Higher scores indicate greater participant satisfaction with the intervention. Score on a scale, typically 0-32 for CSQ-8","Week 12",{"measure":18,"description":19,"timeFrame":12},"Number of Adults Enrolled (Participants)","Number of adults who met eligibility criteria and enrolled in the study",{"measure":21,"description":22,"timeFrame":23},"Retention Rate (Percentage of enrolled participants)","Proportion of enrolled participants who completed the 12-week study","Week 4, 8, 12",[25,29],{"measure":26,"description":27,"timeFrame":28},"Change in Body Weight in Kilograms","Body weight will be measured using a calibrated digital scale in kilograms. Change from baseline to Week 12 will be evaluated.","Baseline and Week 12",{"measure":30,"description":31,"timeFrame":16},"Intervention Usability (SUS)","Usability will be assessed using the System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating greater usability.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","This is a single-arm feasibility pilot study. All enrolled participants will receive the same 12-week app-delivered resistance training intervention (PLAN-RT 1.0); there is no control or comparison group. This design was selected to first establish feasibility, acceptability, and preliminary outcome signals of the intervention before proceeding to a larger controlled trial. The intervention integrates a smartwatch, resistance band, and smartphone applications to deliver personalized goal setting, action planning, contextual prompts, self-monitoring, and feedback, grounded in Self-Regulation Theory and Habit Formation Theory.","PREVENTION",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","GLP-1 receptor agonist (GLP-1RA) therapies have emerged as highly effective pharmacological treatments for obesity, yet weight loss achieved through these agents is accompanied by significant lean mass loss. This is particularly relevant for midlife women who are concurrently vulnerable to age- and menopause-related declines in skeletal muscle mass and physical function. Resistance training (RT) is recommended as an evidence-based strategy for preserving lean mass during weight loss treatments, yet no theory-grounded, scalable intervention exists to support RT initiation and maintenance in midlife women. PLAN-RT 1.0 is a 12-week, app-delivered resistance training intervention developed for midlife women (aged 40-59) receiving GLP-1RA therapy for obesity. The intervention integrates three complementary theoretical frameworks - Self-Regulation Theory (initiation), Habit Formation Theory (cue-behavior-reward), and the Affective Response Theory (intrinsic reinforcement) - operationalized through a structured set of behavior change techniques delivered via digital health technologies. This proposed single-arm feasibility pilot (n=15) pursues two specific aims. Aim 1 evaluates the feasibility and acceptability of PLAN-RT 1.0 using pre-specified benchmarks across enrollment, adherence, retention, and ecological momentary assessment (EMA) response rate, alongside exploratory pre-post analyses of body composition, muscle strength and physical function, and behavioral outcomes. Aim 2 examines the mechanistic role of affective response to RT as a driver of habit formation, using EMA-based per-session affective valence data and mixed methods to characterize how GLP-1RA-mediated dopaminergic changes may alter the intrinsic reward signal from exercise. Feasibility benchmarks, variance estimates, and mechanistic insights from PLAN-RT 1.0 will directly inform the development of PLAN-RT 2.0 through an R21 factorial optimization trial (MOST framework) and ultimately an R01 efficacy trial, establishing a scalable clinical tool for lean mass preservation in midlife women receiving GLP-1RA therapy.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"PLAN-RT 1.0","EXPERIMENTAL","Participants will receive PLAN-RT 1.0, a 12-week digitally delivered resistance training intervention designed for physically inactive midlife women (ages 40-59 years) who have recently initiated GLP-1 receptor agonist (GLP-1RA) therapy. The intervention combines a Fitbit Versa smartwatch, LIT AXIS™ smart resistance band, and smartphone applications integrated through the Pathverse platform to support resistance training participation. Participants will receive exercise instruction and form guidance, personalized resistance training goal setting, implementation intention-based action planning, contextual prompts delivered through smartwatch notifications, self-monitoring of exercise behavior, and feedback on goal attainment. Resistance training activities include bodyweight and resistance band exercises performed according to a structured progressive program over 12 weeks.",[47],"Behavioral: PLAN-RT 1.0",[49],{"type":50,"name":43,"description":51,"armGroupLabels":52,"otherNames":32},"BEHAVIORAL","A 12-week theory-based, app-delivered resistance training behavioral intervention incorporating behavior change techniques based on Self-Regulation Theory and Habit Formation Theory to promote initiation and maintenance of resistance training among midlife women receiving GLP-1RA therapy. The intervention includes exercise instruction, goal setting, action planning, contextual cues, self-monitoring, and feedback delivered through integrated digital health technologies.",[43],[54,59],{"name":55,"role":56,"phone":57,"phoneExt":32,"email":58},"Shiyu Li","CONTACT","225-578-0977","sli40@lsu.edu",{"name":60,"role":56,"phone":61,"phoneExt":32,"email":62},"Kimberly Allen","225-578-2363","kmallen@lsu.edu",[64],{"facility":65,"status":32,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Louisiana State University School of Kinesiology","Baton Rouge","Louisiana","70803","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-91.18747,30.44332,{"lat":75,"lon":74},[78,80,82],{"name":79,"role":56,"phone":57,"phoneExt":32,"email":58},"Shiyu Li, Ph.D.",{"name":81,"role":56,"phone":61,"phoneExt":32,"email":62},"Kimberly M Allen, M.A.",{"name":79,"role":83,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Shiyu Li, PhD","Assistant Professor",[88,90],{"name":89,"class":6},"Louisiana Clinical and Translational Science Center",{"name":91,"class":6},"Pennington Biomedical Research Center","100653597","digital-resistance-training-for-midlife-women-using-glp-1-100653597",false,"NCT07787533","Digital Resistance Training for Midlife Women Using GLP-1","Developing a Scalable Digital Resistance Training Intervention to Preserve Muscle Function in Midlife Women Receiving GLP-1 Therapy","PLAN-RT","Inclusion Criteria: Participants must meet all of the following criteria:\n\n* Female, age 40 to 54 years.\n* Recently initiated GLP-1 receptor agonist (GLP-1RA) therapy within the past 6 months.\n* Body mass index (BMI) ≥27 kg\u002Fm².\n* Not currently participating in regular resistance training (self-reported absence of regular resistance training during the previous month).\n* Able to stand, sit, and perform bodyweight movements without assistive devices.\n* Owns a compatible smartphone (iOS or Android) with cellular or Wi-Fi access and is willing to use study applications.\n* Able to read, understand, and provide informed consent in English.\n* Willing and able to attend required in-person study visits.\n\nExclusion Criteria: Participants will be excluded if they meet any of the following criteria:\n\n* Plans to discontinue GLP-1RA therapy or substantially modify treatment during the 12-week study period.\n* Self-reported musculoskeletal injury, orthopedic limitation, or surgery within the previous 6 months that would contraindicate resistance training participation.\n* Self-reported unstable cardiovascular disease or cardiac event within the previous 6 months.\n* Currently pregnant or planning to become pregnant during the study period.\n* Active eating disorder or psychiatric condition that may interfere with study participation.\n* Unable to use smartphone applications required for the intervention.\n* Current participation in another pharmacological, behavioral, weight management, or chronic disease management program that could confound study outcomes.","FEMALE","40 Years","59 Years",{"count":104,"type":105},15,"ESTIMATED","INTERVENTIONAL",[34],"The goal of PLAN-RT 1.0 to learn if a 12-week app-based strength training program can help midlife women build and stick with a regular strength training routine while they are taking GLP-1 medication for weight loss. PLAN-RT 1.0 targets women ages 40 to 59 who were not regularly exercising before starting GLP-1 medication.\n\nThe main questions this study aims to answer are: (1) Is the PLAN-RT 1.0 program feasible and acceptable to participants (based on how many people join, stay in the study, and use the program)? (2) Does the program lead to early changes in muscle strength, body composition, physical function, and exercise habits?",[110,111,112,113,114,115,116],"Women's Health","Obesity & Overweight","Perimenopausal Women","Digital Intervention","Behavior Change","glp1 Agonist","Resistance Exercise",[118,119,120,121,122],"resistance training","women's health","obesity","perimenopausal women","digital intervention","NOT_YET_RECRUITING","2026-08-21",{"date":126,"type":127},"2026-08-26","ACTUAL",{"date":129,"type":105},"2026-11-01",{"date":131,"type":105},"2027-06-30",{"name":5,"class":6},1]