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

February 8, 2024 updated by: Sofie Power, Coventry University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Intervention
Participants will undertake a 12 week, online delivered, home-based exercise programme.
Behavioral: Home-based exercise programme
A 12 week, online delivered, home-based exercise programme.
No Intervention: Waitlist Control
Participants assigned to the waitlist control will adhere to their usual routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Calculated at trial end, i.e.12 weeks after inclusion.
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.
Calculated at trial end, i.e. 12 weeks after inclusion.
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.
Calculated at trial end, i.e. 12 weeks after inclusion.
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.
Calculated at trial end, i.e. 12 weeks after inclusion.
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.
Calculated at trial end, i.e. 12 weeks after inclusion.
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.
Evaluated after intervention period, i.e. up to 12 weeks after inclusion offer.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Mass will be measured using the BiodyXpertZMII.
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 Body Fat Percentage will be measured using the BiodyXpertZMII.
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 Fat Free Mass will be measured using the BiodyXpertZMII.
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.
BMI will be calculated from combining body mass (kg) and participant height (cm).
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.
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.
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.
Taken at baseline, 6 weeks and 12 weeks/programme completion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Taken at baseline and 12 weeks/programme completion.
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.
Taken at baseline and 12 weeks/programme completion.
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.
Taken at baseline and 12 weeks/programme completion.
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.
Taken at baseline, 6 weeks and 12 weeks/programme completion.
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.
Taken at baseline, 6 weeks and 12 weeks/programme completion.
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.
Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.
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'.
Three/four times weekly, throughout the 12 week programme, after each exercise session is complete.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coventry University

Investigators

  • Principal Investigator: Sofie Power, Coventry University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P149993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight and Obesity

Clinical Trials on Home-based exercise programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe