Home-Based Exercise for Adults Living With Overweight and Obesity

Study Overview
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Brief Summary
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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. It is hypothesised that the exercise programme will be feasible, accessible and acceptable.

Official Title
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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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Home-based exercise programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥25kg/m² or BMI ≥30kg/m² English speaking Able to follow visual and verbal instructions Access to the internet and accompanying technology (e.g. laptop or tablet) Physically able to undertake aerobic, resistance and flexibility exercise Exclusion Criteria: Unable to provide informed consent Receiving invasive medical treatment or planned surgery preceding to, or during, the programme Severe mental or physical limitations precluding participation safely in the home environment No access to the internet and/or facilitative technology such as a laptop or tablet Pregnancy Current smoker or vaping. Currently or very recently stopped taking weight loss medication (within the last two weeks) Recently experienced substantial weight change (defined as 5% within 6-12 months) Presence of contraindications to exercise Pacemaker and/or other implanted metal device At high risk of cardiovascular event

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Participants will undertake a 12 week, online delivered, home-based exercise programme. | Behavioral: Home-based exercise programme<br>* A 12 week, online delivered, home-based exercise programme.<br>|
| No Intervention: Waitlist Control<br>Participants assigned to the waitlist control will adhere to their usual routine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Feasibility and acceptability of the programme through adherence | Adherence will calculated by monitoring the online platform engagement and outputs from post exercise session questionnaires. | Calculated at trial end, i.e. 12 weeks after inclusion. | 
| Feasibility and acceptability of the programme through intervention engagement | Engagement will be calculated by monitoring participant's activity on the online platform. | Calculated at trial end, i.e. 12 weeks after inclusion. | 
| 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. | Calculated at trial end, i.e. 12 weeks after inclusion. | 
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Body Mass (kg) | Participant Body Mass will be measured using calibrated, digital scales. | Taken at baseline, 6 weeks and 12 weeks/programme completion. | 
| Participant Body Fat Mass (kg) | Participant Body Fat Mass will be measured using the BiodyXpertZMII. | Taken at baseline, 6 weeks and 12 weeks/programme completion. | 
| Participant Body Fat Percentage (%) | Participant Body Fat Percentage will be measured using the BiodyXpertZMII. | Taken at baseline, 6 weeks and 12 weeks/programme completion. | 
| Participant Fat Free Mass (%) | Participant Fat Free Mass will be measured using the BiodyXpertZMII. | Taken at baseline, 6 weeks and 12 weeks/programme completion. | 
| Participant Body Mass Index (kg/m^2) | BMI will be calculated from combining body mass (kg) and participant height (cm). | Taken at baseline, 6 weeks and 12 weeks/programme completion. | 
| Participant waist to hip ratio | Waist to hip ratio will be calculated from combining measures of waist circumference (cm) and hip circumference (cm). | Taken at baseline, 6 weeks and 12 weeks/programme completion. | 
| Participant resting blood pressure (mmHg) | Resting blood pressure (mmHg) will be taken using a blood pressure monitor. | Taken at baseline, 6 weeks and 12 weeks/programme completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home-based exercise