Overweight and ObesityWEIGHNCT05807386
Home-Based Exercise for Adults Living With Overweight and Obesity
A study testing Home-based exercise programme in people with Overweight and Obesity, run by Coventry University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Home-based exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sofie Power contact
Prof. David Broom contact
About this study
Official title: 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
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.
- Conditions
- Overweight and Obesity
- Being tested
- Home-based exercise programme
- Keywords
- home-based exercise
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise programmeBehavioural
A 12 week, online delivered, home-based exercise programme.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Participants will undertake a 12 week, online delivered, home-based exercise programme. Receives: Behavioral: Home-based exercise programme |
| Waitlist Control | No intervention | Participants assigned to the waitlist control will adhere to their usual routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluated after intervention period, i.e. up to 12 weeks after inclusion offer.
Secondary outcomes (7)
Participant Body Mass (kg)
Participant Body Mass will be measured using calibrated, digital scales.
Measured: 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.
Measured: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Body Fat Percentage (%)
Participant Body Fat Percentage will be measured using the BiodyXpertZMII.
Measured: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Fat Free Mass (%)
Participant Fat Free Mass will be measured using the BiodyXpertZMII.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofie Power, Coventry University
- Investigators
- Sofie Power, Principal investigator, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807386
- Sponsor's protocol ID
- P149993
- Acronym
- WEIGH
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05807386
- Acronym / sponsor ID
- WEIGH / P149993
- Conditions
- Overweight and Obesity
- Keywords
- home-based exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Home-based exercise programmeParticipants will undertake a 12 week, online delivered, home-based exercise programme. |
| Waitlist Control | No intervention | –Participants assigned to the waitlist control will adhere to their usual routine. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise programmeA 12 week, online delivered, home-based exercise programme. | Behavioural | Exercise Intervention |
Primary outcome
Feasibility and acceptability of the programme through recruitment rate
Time frame: Calculated at trial end, i.e.12 weeks after inclusion.
Recruitment rate will be calculated by dividing the number of eligible candidates by the number who consent to participate.
Feasibility and acceptability of the programme through attrition
Time frame: Calculated at trial end, i.e. 12 weeks after inclusion.
Attrition rate will be defined and calculated as discontinuation of the intervention without return.
Feasibility and acceptability of the programme through adherence
Time frame: Calculated at trial end, i.e. 12 weeks after inclusion.
Adherence will calculated by monitoring the online platform engagement and outputs from post exercise session questionnaires.
Feasibility and acceptability of the programme through intervention engagement
Time frame: Calculated at trial end, i.e. 12 weeks after inclusion.
Engagement will be calculated by monitoring participant's activity on the online platform.
Feasibility and acceptability of the programme through completion rate
Time frame: Calculated at trial end, i.e. 12 weeks after inclusion.
Completion rate will be calculated by dividing the number of participants who successfully complete the programme, by the number of participants that attempt.
Acceptability and experience of the programme via participant interviews
Time frame: Evaluated after intervention period, i.e. up to 12 weeks after inclusion offer.
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.
7 secondary outcomes
Participant Body Mass (kg)
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Body Fat Mass (kg)
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Body Fat Percentage (%)
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Fat Free Mass (%)
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant Body Mass Index (kg/m^2)
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant waist to hip ratio
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Participant resting blood pressure (mmHg)
Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofie Power contact
Prof. David Broom contact
Sofie Power principal investigator
Coventry University
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise programme in people with Overweight and Obesity, run by Coventry University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Power (powers3@coventry.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the programme through recruitment rate (time frame: Calculated at trial end, i.e.12 weeks after inclusion.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.