[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501294":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":80,"studyPopulation":80,"armGroups":84,"interventions":95,"overallOfficials":101,"centralContacts":105,"locations":80,"responsibleParty":112,"collaborators":80,"id":114,"slug":80,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":80,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":135,"whyStopped":80,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":80},{"fullName":5,"class":6},"Coventry University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":53},[9,13,17,20,23,26],{"measure":10,"description":11,"timeFrame":12},"Feasibility and acceptability of the programme through recruitment rate","Recruitment rate will be calculated by dividing the number of eligible candidates by the number who consent to participate.","Calculated at trial end, i.e.12 weeks after inclusion.",{"measure":14,"description":15,"timeFrame":16},"Feasibility and acceptability of the programme through attrition","Attrition rate will be defined and calculated as discontinuation of the intervention without return.","Calculated at trial end, i.e. 12 weeks after inclusion.",{"measure":18,"description":19,"timeFrame":16},"Feasibility and acceptability of the programme through adherence","Adherence will calculated by monitoring the online platform engagement and outputs from post exercise session questionnaires.",{"measure":21,"description":22,"timeFrame":16},"Feasibility and acceptability of the programme through intervention engagement","Engagement will be calculated by monitoring participant's activity on the online platform.",{"measure":24,"description":25,"timeFrame":16},"Feasibility and acceptability of the programme through completion rate","Completion rate will be calculated by dividing the number of participants who successfully complete the programme, by the number of participants that attempt.",{"measure":27,"description":28,"timeFrame":29},"Acceptability and experience of the programme via participant interviews","Interviews will take place between the researcher and participant to explore their experience on the programme and identifying areas for improvement. This may be with participants who completed the intervention, withdrew or declined to participate.","Evaluated after intervention period, i.e. up to 12 weeks after inclusion offer.",[31,35,38,41,44,47,50],{"measure":32,"description":33,"timeFrame":34},"Participant Body Mass (kg)","Participant Body Mass will be measured using calibrated, digital scales.","Taken at baseline, 6 weeks and 12 weeks\u002Fprogramme completion.",{"measure":36,"description":37,"timeFrame":34},"Participant Body Fat Mass (kg)","Participant Body Fat Mass will be measured using the BiodyXpertZMII.",{"measure":39,"description":40,"timeFrame":34},"Participant Body Fat Percentage (%)","Participant Body Fat Percentage will be measured using the BiodyXpertZMII.",{"measure":42,"description":43,"timeFrame":34},"Participant Fat Free Mass (%)","Participant Fat Free Mass will be measured using the BiodyXpertZMII.",{"measure":45,"description":46,"timeFrame":34},"Participant Body Mass Index (kg\u002Fm^2)","BMI will be calculated from combining body mass (kg) and participant height (cm).",{"measure":48,"description":49,"timeFrame":34},"Participant waist to hip ratio","Waist to hip ratio will be calculated from combining measures of waist circumference (cm) and hip circumference (cm).",{"measure":51,"description":52,"timeFrame":34},"Participant resting blood pressure (mmHg)","Resting diastolic and systolic blood pressure (mmHg) will be taken using a blood pressure monitor.",[54,58,61,64,67,70,74],{"measure":55,"description":56,"timeFrame":57},"Functional Ability (aerobic capacity and endurance) change through Six Minute Walk test","This will be measured using the Six Minute Walk test and change will be compared within and between participants.","Taken at baseline and 12 weeks\u002Fprogramme completion.",{"measure":59,"description":60,"timeFrame":57},"Functional Ability (leg strength and endurance) change through 30s Sit to Stand test","This will be measured using the 30s Sit to Stand test and change will be compared within and between participants.",{"measure":62,"description":63,"timeFrame":57},"Functional Ability (strength) change through hand grip strength test","This will be measured using the hand grip dynamometer, and change will be compared within and between participants.",{"measure":65,"description":66,"timeFrame":34},"Quality of Life and Cost Effectiveness","This will be measured using the European Quality of Life Five Dimension Questionnaire (EQ-5D-5L), and change will be compared within and between participants. Scores range from 1-5 with lower scores associated with a better outcome.",{"measure":68,"description":69,"timeFrame":34},"Physical Activity","This will be measured using the International Physical Activity Questionnaire - Long Form (IPAQ-LF), and change will be compared within and between participants. Scores may be categorised and\u002For sub scores calculated for each domain where higher scores are associated with better physical activity behaviour.",{"measure":71,"description":72,"timeFrame":73},"Exercise Intensity","Exercise intensity will be recorded using the Borg Category Ratio (CR-10) scale, and change will be compared to the prescribed programme intensity. Higher scores are associated with a higher exercise intensity.","Three\u002Ffour times weekly, throughout the 12 week programme, after each exercise session is complete.",{"measure":75,"description":76,"timeFrame":73},"Exercise Feeling","Exercise feeling will be recorded using the Feeling Scale, that ranges from -5 to +5, where -5 indicates feeling 'Very Bad' and +5 indicates feeling 'Very Good'.",{"allocation":78,"interventionModel":79,"interventionModelDescription":80,"primaryPurpose":81,"observationalModel":80,"timePerspective":80,"maskingInfo":82},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":83,"maskingDescription":80,"whoMasked":80},"NONE",[85,91],{"label":86,"type":87,"description":88,"interventionNames":89},"Exercise Intervention","EXPERIMENTAL","Participants will undertake a 12 week, online delivered, home-based exercise programme.",[90],"Behavioral: Home-based exercise programme",{"label":92,"type":93,"description":94,"interventionNames":80},"Waitlist Control","NO_INTERVENTION","Participants assigned to the waitlist control will adhere to their usual routine.",[96],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":80},"BEHAVIORAL","Home-based exercise programme","A 12 week, online delivered, home-based exercise programme.",[86],[102],{"name":103,"affiliation":5,"role":104},"Sofie Power","PRINCIPAL_INVESTIGATOR",[106,109],{"name":103,"role":107,"phone":80,"phoneExt":80,"email":108},"CONTACT","powers3@coventry.ac.uk",{"name":110,"role":107,"phone":80,"phoneExt":80,"email":111},"Prof. David Broom","ad5173@coventry.ac.uk",{"type":104,"investigatorFullName":103,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":80,"oldOrganization":80},"Principal Investigator","100501294",false,"NCT05807386","Home-Based Exercise for Adults Living With Overweight and Obesity","WE Are Active and In This toGetHer (WEIGH): a Randomised Controlled Trial to Ascertain the Feasibility of a Home-based Exercise Programme for People Living With Overweight and Obesity","WEIGH","Inclusion Criteria:\n\n* BMI ≥25kg\u002Fm² or BMI ≥30kg\u002Fm²\n* English speaking\n* Able to follow visual and verbal instructions\n* Access to the internet and accompanying technology (e.g. laptop or tablet)\n* Physically able to undertake aerobic, resistance and flexibility exercise\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Receiving invasive medical treatment or planned surgery preceding to, or during, the programme\n* Severe mental or physical limitations precluding participation safely in the home environment\n* No access to the internet and\u002For facilitative technology such as a laptop or tablet\n* Pregnancy\n* Current smoker or vaping.\n* Currently or very recently stopped taking weight loss medication (within the last two weeks)\n* Recently experienced substantial weight change (defined as 5% within 6-12 months)\n* Presence of contraindications to exercise\n* Pacemaker and\u002For other implanted metal device\n* At high risk of cardiovascular event","ALL","18 Years","64 Years",{"count":125,"type":126},30,"ESTIMATED","INTERVENTIONAL",[129],"NA","The study aims to implement a 12-week home-based exercise programme utilising an online intervention delivery platform. The focus will be on increasing exercise behaviour within the participant's home setting using aerobic, resistance and flexibility exercises as well as behaviour change techniques. Following the programme, semi-structured interviews will be conducted, to explore participant experiences.\n\nIt is hypothesised that the exercise programme will be feasible, accessible and acceptable.",[132],"Overweight and Obesity",[134],"home-based exercise","NOT_YET_RECRUITING","2024-02-08",{"date":138,"type":139},"2024-02-12","ACTUAL",{"date":141,"type":126},"2025-01",{"date":143,"type":126},"2027-06",{"name":5,"class":6}]