Home-Based Exercise for Adults Living With Overweight and Obesity

Overweight and Obesity Clinical Trial

— WEIGH  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05807386
• Other study ID #: P149993
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: Coventry University
• Contact: Sofie Power
• Email: powers3[@]coventry.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Home-based exercise programme
A 12 week, online delivered, home-based exercise programme.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coventry University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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/programme completion.
Other	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.	Taken at baseline and 12 weeks/programme completion.
Other	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.	Taken at baseline and 12 weeks/programme completion.
Other	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.	Taken at baseline, 6 weeks and 12 weeks/programme completion.
Other	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.	Taken at baseline, 6 weeks and 12 weeks/programme completion.
Other	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/four times weekly, throughout the 12 week programme, after each exercise session is complete.
Other	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'.	Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Participant Body Mass (kg)	Participant Body Mass will be measured using calibrated, digital scales.	Taken at baseline, 6 weeks and 12 weeks/programme completion.
Secondary	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.
Secondary	Participant Body Fat Percentage (%)	Participant Body Fat Percentage will be measured using the BiodyXpertZMII.	Taken at baseline, 6 weeks and 12 weeks/programme completion.
Secondary	Participant Fat Free Mass (%)	Participant Fat Free Mass will be measured using the BiodyXpertZMII.	Taken at baseline, 6 weeks and 12 weeks/programme completion.
Secondary	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.
Secondary	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.
Secondary	Participant resting blood pressure (mmHg)	Resting diastolic and systolic blood pressure (mmHg) will be taken using a blood pressure monitor.	Taken at baseline, 6 weeks and 12 weeks/programme completion.