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NCT Number: NCT05807386

Home-Based Exercise for Adults 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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based exercise programme

Behavioral

A 12 week, online delivered, home-based exercise programme.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Participant Body Mass (kg)

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    Participant Body Mass will be measured using calibrated, digital scales.

  2. Participant Body Fat Mass (kg)

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    Participant Body Fat Mass will be measured using the BiodyXpertZMII.

  3. Participant Body Fat Percentage (%)

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    Participant Body Fat Percentage will be measured using the BiodyXpertZMII.

  4. Participant Fat Free Mass (%)

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    Participant Fat Free Mass will be measured using the BiodyXpertZMII.

  5. Participant Body Mass Index (kg/m^2)

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    BMI will be calculated from combining body mass (kg) and participant height (cm).

  6. Participant waist to hip ratio

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    Waist to hip ratio will be calculated from combining measures of waist circumference (cm) and hip circumference (cm).

  7. Participant resting blood pressure (mmHg)

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    Resting diastolic and systolic blood pressure (mmHg) will be taken using a blood pressure monitor.

Other outcomes

  1. Functional Ability (aerobic capacity and endurance) change through Six Minute Walk test

    Time frame: Taken at baseline and 12 weeks/programme completion.

    This will be measured using the Six Minute Walk test and change will be compared within and between participants.

  2. Functional Ability (leg strength and endurance) change through 30s Sit to Stand test

    Time frame: Taken at baseline and 12 weeks/programme completion.

    This will be measured using the 30s Sit to Stand test and change will be compared within and between participants.

  3. Functional Ability (strength) change through hand grip strength test

    Time frame: Taken at baseline and 12 weeks/programme completion.

    This will be measured using the hand grip dynamometer, and change will be compared within and between participants.

  4. Quality of Life and Cost Effectiveness

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    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.

  5. Physical Activity

    Time frame: Taken at baseline, 6 weeks and 12 weeks/programme completion.

    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.

  6. Exercise Intensity

    Time frame: Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.

    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.

  7. Exercise Feeling

    Time frame: Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.

    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'.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. David Broom

CONTACT

[email protected]

Sofie Power

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Coventry University

Other

Registry information

Official study 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

Acronym: WEIGH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2023
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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