Clinical trial NCT05807386: Home-Based Exercise for Adults Living With Overweight and Obesity
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: home-based exercise
Lead sponsor: Coventry University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and acceptability of the programme through recruitment rate
timeFrame: Calculated at trial end, i.e.12 weeks after inclusion.
measure: Feasibility and acceptability of the programme through attrition
timeFrame: Calculated at trial end, i.e. 12 weeks after inclusion.
measure: Feasibility and acceptability of the programme through adherence
timeFrame: Calculated at trial end, i.e. 12 weeks after inclusion.
measure: Feasibility and acceptability of the programme through intervention engagement
timeFrame: Calculated at trial end, i.e. 12 weeks after inclusion.
measure: Feasibility and acceptability of the programme through completion rate
timeFrame: Calculated at trial end, i.e. 12 weeks after inclusion.
measure: Acceptability and experience of the programme via participant interviews
timeFrame: Evaluated after intervention period, i.e. up to 12 weeks after inclusion offer.
Secondary outcomes:
measure: Participant Body Mass (kg)
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Participant Body Fat Mass (kg)
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Participant Body Fat Percentage (%)
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Participant Fat Free Mass (%)
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Participant Body Mass Index (kg/m^2)
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Participant waist to hip ratio
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Participant resting blood pressure (mmHg)
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
Other outcomes:
measure: Functional Ability (aerobic capacity and endurance) change through Six Minute Walk test
timeFrame: Taken at baseline and 12 weeks/programme completion.
measure: Functional Ability (leg strength and endurance) change through 30s Sit to Stand test
timeFrame: Taken at baseline and 12 weeks/programme completion.
measure: Functional Ability (strength) change through hand grip strength test
timeFrame: Taken at baseline and 12 weeks/programme completion.
measure: Quality of Life and Cost Effectiveness
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Physical Activity
timeFrame: Taken at baseline, 6 weeks and 12 weeks/programme completion.
measure: Exercise Intensity
timeFrame: Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.
measure: Exercise Feeling
timeFrame: Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.
Locations:
Study officials:
affiliation: Coventry University
name: Sofie Power
role: PRINCIPAL_INVESTIGATOR
References: