An interventional study of Home-based exercise programme in Overweight and Obesity, sponsored by Coventry University. Not yet recruiting. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by Coventry University · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Coventry University is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undertake a 12 week, online delivered, home-based exercise programme.
Behavioral: Home-based exercise programme
Participants assigned to the waitlist control will adhere to their usual routine.
A 12 week, online delivered, home-based exercise programme.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Evaluated after intervention period, i.e. up to 12 weeks after inclusion offer.
Participant Body Mass (kg)
Participant Body Mass will be measured using calibrated, digital scales.
Time frame: 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.
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Body Fat Percentage (%)
Participant Body Fat Percentage will be measured using the BiodyXpertZMII.
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Fat Free Mass (%)
Participant Fat Free Mass will be measured using the BiodyXpertZMII.
Time frame: 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).
Time frame: 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).
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant resting blood pressure (mmHg)
Resting diastolic and systolic blood pressure (mmHg) will be taken using a blood pressure monitor.
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
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.
Time frame: Taken at baseline and 12 weeks/programme completion.
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.
Time frame: Taken at baseline and 12 weeks/programme completion.
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.
Time frame: Taken at baseline and 12 weeks/programme completion.
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.
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
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/or sub scores calculated for each domain where higher scores are associated with better physical activity behaviour.
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
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.
Time frame: Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.
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'.
Time frame: Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.
No study locations are listed for this record.
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Coventry University