search
Back to results

Home-Based Exercise for Adults Living With Overweight and Obesity (WEIGH)

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home-based exercise programme
Sponsored by
Coventry University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring home-based exercise

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise Intervention

    Waitlist Control

    Arm Description

    Participants will undertake a 12 week, online delivered, home-based exercise programme.

    Participants assigned to the waitlist control will adhere to their usual routine.

    Outcomes

    Primary Outcome Measures

    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.
    Feasibility and acceptability of the programme through attrition
    Attrition rate will be defined and calculated as discontinuation of the intervention without return.
    Feasibility and acceptability of the programme through adherence
    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
    Engagement will be calculated by monitoring participant's activity on the online platform.
    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.
    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.

    Secondary Outcome Measures

    Participant Body Mass (kg)
    Participant Body Mass will be measured using calibrated, digital scales.
    Participant Body Fat Mass (kg)
    Participant Body Fat Mass will be measured using the BiodyXpertZMII.
    Participant Body Fat Percentage (%)
    Participant Body Fat Percentage will be measured using the BiodyXpertZMII.
    Participant Fat Free Mass (%)
    Participant Fat Free Mass will be measured using the BiodyXpertZMII.
    Participant Body Mass Index (kg/m^2)
    BMI will be calculated from combining body mass (kg) and participant height (cm).
    Participant waist to hip ratio
    Waist to hip ratio will be calculated from combining measures of waist circumference (cm) and hip circumference (cm).
    Participant resting blood pressure (mmHg)
    Resting blood pressure (mmHg) will be taken using a blood pressure monitor.

    Full Information

    First Posted
    March 7, 2023
    Last Updated
    April 25, 2023
    Sponsor
    Coventry University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05807386
    Brief Title
    Home-Based Exercise for Adults Living With Overweight and Obesity
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Coventry University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity
    Keywords
    home-based exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will undertake a 12 week, online delivered, home-based exercise programme.
    Arm Title
    Waitlist Control
    Arm Type
    No Intervention
    Arm Description
    Participants assigned to the waitlist control will adhere to their usual routine.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Home-based exercise programme
    Intervention Description
    A 12 week, online delivered, home-based exercise programme.
    Primary Outcome Measure Information:
    Title
    Feasibility and acceptability of the programme through recruitment rate
    Description
    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.
    Title
    Feasibility and acceptability of the programme through attrition
    Description
    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.
    Title
    Feasibility and acceptability of the programme through adherence
    Description
    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.
    Title
    Feasibility and acceptability of the programme through intervention engagement
    Description
    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.
    Title
    Feasibility and acceptability of the programme through completion rate
    Description
    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.
    Title
    Acceptability and experience of the programme via participant interviews
    Description
    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.
    Secondary Outcome Measure Information:
    Title
    Participant Body Mass (kg)
    Description
    Participant Body Mass will be measured using calibrated, digital scales.
    Time Frame
    Taken at baseline, 6 weeks and 12 weeks/programme completion.
    Title
    Participant Body Fat Mass (kg)
    Description
    Participant Body Fat Mass will be measured using the BiodyXpertZMII.
    Time Frame
    Taken at baseline, 6 weeks and 12 weeks/programme completion.
    Title
    Participant Body Fat Percentage (%)
    Description
    Participant Body Fat Percentage will be measured using the BiodyXpertZMII.
    Time Frame
    Taken at baseline, 6 weeks and 12 weeks/programme completion.
    Title
    Participant Fat Free Mass (%)
    Description
    Participant Fat Free Mass will be measured using the BiodyXpertZMII.
    Time Frame
    Taken at baseline, 6 weeks and 12 weeks/programme completion.
    Title
    Participant Body Mass Index (kg/m^2)
    Description
    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.
    Title
    Participant waist to hip ratio
    Description
    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.
    Title
    Participant resting blood pressure (mmHg)
    Description
    Resting blood pressure (mmHg) will be taken using a blood pressure monitor.
    Time Frame
    Taken at baseline, 6 weeks and 12 weeks/programme completion.
    Other Pre-specified Outcome Measures:
    Title
    Functional Ability (aerobic capacity and endurance) change through Six Minute Walk test
    Description
    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.
    Title
    Functional Ability (leg strength and endurance) change through 30s Sit to Stand test
    Description
    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.
    Title
    Functional Ability (strength) change through hand grip strength test
    Description
    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.
    Title
    Quality of Life and Cost Effectiveness
    Description
    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.
    Title
    Physical Activity
    Description
    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.
    Title
    Exercise Intensity
    Description
    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.
    Title
    Exercise Feeling
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sofie Power
    Email
    powers3@coventry.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Prof. David Broom
    Email
    ad5173@coventry.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sofie Power
    Organizational Affiliation
    Coventry University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not a plan to make IPD available.

    Learn more about this trial

    Home-Based Exercise for Adults Living With Overweight and Obesity

    We'll reach out to this number within 24 hrs