Home-Based Exercise for Adults Living With Overweight and Obesity

NCT05807386 | Not Yet Recruiting

• 1 other identifier: P149993
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity

Keywords

home-based exercise

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (7)

• Participant Body Mass (kg)

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

• Participant Body Fat Mass (kg)

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

• Participant Body Fat Percentage (%)

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

• Participant Fat Free Mass (%)

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

• Participant Body Mass Index (kg/m^2)

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

Other Outcomes (7)

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

  Taken at baseline and 12 weeks/programme completion.

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

  Taken at baseline and 12 weeks/programme completion.

• Functional Ability (strength) change through hand grip strength test

  Taken at baseline and 12 weeks/programme completion.

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Behavioral: Home-based exercise programme

Waitlist Control

NO INTERVENTION

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

Interventions

Home-based exercise programme BEHAVIORAL

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

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coventry University: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sofie Power

  Coventry University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Power

CONTACT

powers3@coventry.ac.uk

Prof. David Broom

CONTACT

ad5173@coventry.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 11, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share