ExerciseNCT04766372
A Multi-component Physical Activity Intervention for Adolescent Girls
A study testing Behaviour change in people with Exercise, run by Liverpool John Moores University at 3 sites in 2 countries.
Trial summary
A four-arm randomised pilot trial involving: 1. Physical activity programme only - live exercise sessions, social support, standardised text messages 2. Individual behaviour change support only - regular one-to-one video calls with an activity mentor 3. Read more about this study
- Who is it for?
- Ages 13 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Behaviour change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Nov 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female
- 13-16 years
- Living in the UK or Ireland
- Would like support with becoming more physically active
- Ability to participate in moderate intensity physical activity according to the Physical Activity Readiness Questionnaire
Who cannot join
- Have taken part in previous HERizon study
- Currently doing more than 1 hour of exercise or sport every day.
- Currently pregnant
- Not having access to at least ONE of the following: a smartphone, home computer, or parent smartphone.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Liverpool John Moores University
Liverpool, Merseyside, L3 5AF
University of Liverpool
Liverpool
About this study
Official title: A Multi-component Physical Activity Intervention for Adolescent Girls: Feasibility Cluster Randomised Controlled Trial
A four-arm randomised pilot trial involving:
- Physical activity programme only - live exercise sessions, social support, standardised text messages
- Individual behaviour change support only - regular one-to-one video calls with an activity mentor
- Combined - Physical activity provision and individual behaviour change support
- Usual care control All groups will be provided with a menu of physical activities.
Read more
Objectives.
To conduct a RE-AIM evaluation of a 6-month multi-component PA intervention for adolescent girls, through investigating:
- Who the intervention reaches, how representative they are for the population (Reach, Adoption) and who is most likely to benefit from the intervention (Reach);
- The extent to which the intervention is delivered as intended (Implementation), and factors that affect this (Adoption);
- Preliminary impact on participants' PA, sedentary behaviour, cardiovascular fitness and psychological wellbeing at 3, 6 and 12 months (Effectiveness, Maintenance);
- The qualitatively examine the acceptability of the intervention for adolescent girls, and identify necessary refinements;
- To gather data to inform a sample size calculation for a main trail
Read the detailed description
Procedures. Following written informed assent of participants and consent of parents/guardians, the researcher will have a short introductory video call with the participant and parent to talk through the next steps, give instructions on how to complete fitness tests and answer any questions. After this introduction, participants can carry out their fitness testing at home remotely under the supervision of the researcher (via Zoom) or their parent. Following written consent, participants will complete all questionnaires online (approximately 15 minutes) - self-reported physical activity, sociodemographic and psychosocial measures (behavioural regulation in exercise questionnaire, body-appreciation scale and self-esteem scale - details of each listed below). Participants will then complete the fitness measures using the Resistance Training for Teens (RTFT) app (30 minutes) - 20m shuttle run tests, long jump and push up test. Participants will wear an Actigraph accelerometer on their don-dominant wrist continuously, as outlined in the study protocol, for 9 days before starting their 12-week physical activity programme. In total, assessments should take approximately one hour and will be conducted at baseline (week 0), post-intervention (week 12) and follow up (week 24).
Randomisation. Participants will be randomly allocated to one of the four intervention arms following baseline measures. 40 participants will be allocated to each arm using block randomisation on Microsoft Excel.
Intervention group - The goals of this physical activity intervention are to 1) increase adolescent girls total physical activity levels and 2) improve adolescent girls health behaviours, including body appreciation and motivation. This study hopes to build on our prior feasibility work to help us to understand which components of the intervention are most effective, i.e. a physical activity programme, individual behaviour change support or a combination. To achieve these goals the following elements will be implemented:
- Menu of physical activity options: Participants in all four groups will be given a booklet with suggestions of ways to be physically active, e.g. YouTube workouts, cycling or jogging, sports, or design their own using a home-based exercise booklet. They are asked to do 3 sessions of 30 minutes per week. Participants are asked to record what activity they did and the duration of the session using a method most convenient for them, e.g. notes on their phone, wall calendar or using an activity log template which the investigators will provide.
- Physical activity programme: Participants in groups 1 and 3 will receive -
- Non Reply SMS: Sent to the participant mobile three times per week by the primary researcher, Emma Cowley PhD candidate, from an online non-reply messaging service. This service is password protected. All messages will be standardised (not personally tailored) and will be focused on behaviour change techniques or reminders.
- Live exercise sessions: The researcher (with personal training and physical education teaching qualifications) will host two online group fitness classes each week which participants are also invited to join. This option is to allow participants the potential to engage with the other participants on the programme from the comfort of their own homes. It is also thought that having a scheduled set time to join a class on line may increase motivation and improve adherence, however the choice to join the class is optional. From previous feasibility work, these sessions were a highlight of the programme and often times parents and siblings would join in too. Participants are invited to turn their cameras on for the intro and warm up, however this is not mandatory.
- Access to a social media group: With participant and parental consent, participants are invited to join a private group community online where they can access additional resources provided by the research team, ask questions in an informal setting and communicate with the other participants in the programme. It is well researched that social connection is a facilitator to adolescent girls participation in physical activity and as participants will be exercising from home the investigators feel giving them access to a social, safe and virtual community can help give them this social connectedness to other adolescent girls of the same age. This is not compulsory and participants are free to join the group, leave the group or decline being added to the group without it affecting their participation in the rest of the programme.
- Individual behaviour change support:
- Participants in group 2 and 3 will be partnered with an 'activity mentor' whom they will work with for the duration of the intervention. These activity mentors are postgraduate students either studying for an MSc in sport and exercise psychology, or post-MSc and undertaking professional training. Their role is to support the participants with improving their health behaviours, autonomy and motivation. Participants will receive weekly calls from week 0-6 and then calls on week 9 and 12. Calls will be via phone call, FaceTime or Teams video call. Behaviour change support will be based on self-determination theory principles (autonomy, competence and relatedness; Ryan \& Deci, 2000). Each call will be based on a pre-planned session outline and will be goal orientated, participant centred and focused on physical activity. Calls are expected to last 10-20 minutes per participant. A sub-sample of calls will be audio recorded to assess intervention fidelity.
Control: menu of physical activity options only. As this project runs for 6 months it will not be possible to provide the control group with the full physical activity programme (this is part of a PhD study). However, it is intended to provide the control group participants with intervention materials (home-HIIT booklets, field-based testing instructions) so that participants can implement the physical activity programme without the direct oversight of the research team. At the end of the intervention, control participants will also be offered to do a group behaviour change psychology session with an activity mentor.
- Conditions
- Exercise
- Being tested
- Behaviour change
- Keywords
- physical activity, adolescent girls, feasibility, behaviour change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour changeOther
Using needs supportive, self-determination theory-based, components to improve the physical activity behaviours of adolescent girls.
| Study group | Role | What they receive |
|---|---|---|
| Menu of physical activity options | Experimental | Participants in all 4 groups will receive this booklet with suggestions of ways to be physically active, e.g. YouTube workouts, cycling or jogging, sports, or design their own using a home-based exercise booklet. Participants are asked to do 3 exercise sessions of 30 minutes per week. Participants are asked to record what activity they did and the duration of the session using a method most convenient for them, e.g. notes on their phone, wall calendar or using an activity log template which we will provide.
. Receives: Other: Behaviour change |
| Physical activity programme | Experimental | Participants in the second group with receive the activity menu (as described above) as well as a detailed physical activity programme. This programme includes supportive weekly text messages, access to live workouts and access to an online social community. Receives: Other: Behaviour change |
| Individual behaviour change support | Experimental | Participants in the third group with receive the activity menu (as described above) as well as individual behaviour change support. Each participant is partnered with a trainee sport psychology ("Activity Mentor") who they have weekly video calls with to support their health behaviour change. Receives: Other: Behaviour change |
| Activity Programme & Behaviour Change Support | Experimental | Participants in the fourth group will receive all of the above (exercise menu, live workouts, social community, support texts and weekly calls with an Activity Mentor). Receives: Other: Behaviour change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective physical activity levels
Participants objective PA will be monitored continuously (i.e. 24 h/day) over a nine-day period using an accelerometer (actigraph GT9x software). This device will be worn on their non-dominant wrist and uses the same validated MEMS sensor as the Actigraph GT3X+ model which has been validated (Hanggi et al., 2013) and used extensively with adolescents (Corder et al., 2016). Using the Actigraph, total daily PA, moderate-to-vigorous PA and sedentary time can be assessed.
Measured: Baseline to post-intervention (week 12)
Secondary outcomes (8)
Aerobic capacity
Measured by the 20m shuttle run test which has been validated as an effective instrument for adolescent aerobic capacity (Boreham et al., 1990). Participants will require 20m space e.g. garden or green space. Using the Resistance Training for Teens mobile app, participants will be given written and visual instructions of how to set up and perform the test. Participants are required to run back and forth between two markers (20m distance) on the sound of a beep. The audio can be played through the app.
Measured: week 0, week 12, week 24
Upper body strength
Participants will do a push up test to the cadence of an audio recording. As above, written and visual instructions on how to set up and perform the test are provided on the app, as well as the audio file which sets the push up cadence. Should participants not be able to do a full push up (starting in high plank on hands and toes), they can lower onto their knees. It is important that the push up variation they choose is the same for baseline and post-intervention for fair comparison. No equipment is needed.
Measured: week 0, week 12, week 24
Strength/ Power
Participants will do a long jump to assess their strength/power. They will start from one marker and just as far as they can and mark where they land. They will use a measuring tape to record this distance. If they do not have a measuring tape they can use their feet to measure and do this again for the post-intervention assessment for consistency. Again, the Resistance Training for Teens app provides visual and written instructions on set up and how to perform.
Measured: week 0, week 12, week 24
Change in Physical Activity Motivation
measured by the 19-item Behavioural Regulation in Exercise Questionnaire (BREQ3) (Markland and Tobin, 2004) plus an additional five-items (Wilson et al., 2006). Using a 5 point Likert scale, the maximum score is 5 which indicates a high level of that particular sub-scale of motivation, e.g. intrinsic motivation rr amotivation.
Measured: week 0, week 12, week 24
Change in Body Appreciation
measured by the 10-item Body Appreciation Scale (Avalos et al., 2005). Using a 5-point Likert scale, the maximum score is 5 which indicates a high level of body appreciation.
Measured: week 0, week 12, week 24
Change in Physical Activity Competence
measured by the 4-item Perceived Competence Scale (Matsui \& Muratas, 1997). Using a 7-point Likert scale, the maximum score is 7 which indicates a high level of competence towards physical activity.
Measured: week 0, week 12, week 24
Change in Self-esteeem
measured by the 12-item Adolescent Self-Esteem Questionnaire (Hafekost et al., 2017). Using a 5-point Likert scale, the maximum score is 5 which indicates a high level of self-esteem
Measured: week 0, week 12, week 24
Change in objective physical activity levels
Participants objective PA will be monitored continuously (i.e. 24 h/day) over a nine-day period using an accelerometer (actigraph GT9x software). This device will be worn on their non-dominant wrist and uses the same validated MEMS sensor as the Actigraph GT3X+ model which has been validated (Hanggi et al., 2013) and used extensively with adolescents (Corder et al., 2016). Using the Actigraph, total daily PA, moderate-to-vigorous PA and sedentary time can be assessed.
Measured: Baseline to follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start30 Nov 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using block randomisation on Microsoft Excel, participants will be assigned to one of the four groups following baseline measures
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Dublin City University, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Anton Wagenmakers, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766372
- Sponsor's protocol ID
- HERizonProject2
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will use participant personal data in the ways needed to conduct and analyse the study and if necessary, to verify and defend, when required, the process and outcomes of the study. Personal data will be accessible to the study team. In addition, responsible members of Liverpool John Moores University be given access to personal data for monitoring and/or audit of the study to ensure that the study is complying with applicable regulations. When we do not need to use personal data, it will be deleted or identifiers will be removed. Consent form, contact details, audio recordings etc. will be retained for 10 years. We will not tell anyone that she has taken part in an interview. She will not be identifiable in any ensuing reports or publications.
Publications
Cowley ES, Watson PM, Foweather L, Belton S, Thompson A, Thijssen D, Wagenmakers AJM. "Girls Aren't Meant to Exercise": Perceived Influences on Physical Activity among Adolescent Girls-The HERizon Project. Children (Basel). 2021 Jan 7;8(1):31. doi: 10.3390/children8010031.
PubMed 33430413Cowley ES, Watson PM, Foweather L, Belton S, Mansfield C, Whitcomb-Khan G, Cacciatore I, Thompson A, Thijssen D, Wagenmakers AJM. Formative Evaluation of a Home-Based Physical Activity Intervention for Adolescent Girls-The HERizon Project: A Randomised Controlled Trial. Children (Basel). 2021 Jan 22;8(2):76. doi: 10.3390/children8020076.
PubMed 33499174
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-component Physical Activity Intervention for Adolescent Girls: Feasibility Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04766372
- Acronym / sponsor ID
- HERizonProject2
- Conditions
- Exercise
- Keywords
- physical activity, adolescent girls, feasibility, behaviour change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Dublin City University, University of Liverpool
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A four-arm randomised pilot trial involving:
- Physical activity programme only - live exercise sessions, social support, standardised text messages
- Individual behaviour change support only - regular one-to-one video calls with an activity mentor
- Combined - Physical activity provision and individual behaviour change support
- Usual care control All groups will be provided with a menu of physical activities.
Objectives.
To conduct a RE-AIM evaluation of a 6-month multi-component PA intervention for adolescent girls, through investigating:
- Who the intervention reaches, how representative they are for the population (Reach, Adoption) and who is most likely to benefit from the intervention (Reach);
- The extent to which the intervention is delivered as intended (Implementation), and factors that affect this (Adoption);
- Preliminary impact on participants' PA, sedentary behaviour, cardiovascular fitness and psychological wellbeing at 3, 6 and 12 months (Effectiveness, Maintenance);
- The qualitatively examine the acceptability of the intervention for adolescent girls, and identify necessary refinements;
- To gather data to inform a sample size calculation for a main trail
Detailed description
Procedures. Following written informed assent of participants and consent of parents/guardians, the researcher will have a short introductory video call with the participant and parent to talk through the next steps, give instructions on how to complete fitness tests and answer any questions. After this introduction, participants can carry out their fitness testing at home remotely under the supervision of the researcher (via Zoom) or their parent. Following written consent, participants will complete all questionnaires online (approximately 15 minutes) - self-reported physical activity, sociodemographic and psychosocial measures (behavioural regulation in exercise questionnaire, body-appreciation scale and self-esteem scale - details of each listed below). Participants will then complete the fitness measures using the Resistance Training for Teens (RTFT) app (30 minutes) - 20m shuttle run tests, long jump and push up test. Participants will wear an Actigraph accelerometer on their don-dominant wrist continuously, as outlined in the study protocol, for 9 days before starting their 12-week physical activity programme. In total, assessments should take approximately one hour and will be conducted at baseline (week 0), post-intervention (week 12) and follow up (week 24).
Randomisation. Participants will be randomly allocated to one of the four intervention arms following baseline measures. 40 participants will be allocated to each arm using block randomisation on Microsoft Excel.
Intervention group - The goals of this physical activity intervention are to 1) increase adolescent girls total physical activity levels and 2) improve adolescent girls health behaviours, including body appreciation and motivation. This study hopes to build on our prior feasibility work to help us to understand which components of the intervention are most effective, i.e. a physical activity programme, individual behaviour change support or a combination. To achieve these goals the following elements will be implemented:
- Menu of physical activity options: Participants in all four groups will be given a booklet with suggestions of ways to be physically active, e.g. YouTube workouts, cycling or jogging, sports, or design their own using a home-based exercise booklet. They are asked to do 3 sessions of 30 minutes per week. Participants are asked to record what activity they did and the duration of the session using a method most convenient for them, e.g. notes on their phone, wall calendar or using an activity log template which the investigators will provide.
- Physical activity programme: Participants in groups 1 and 3 will receive -
- Non Reply SMS: Sent to the participant mobile three times per week by the primary researcher, Emma Cowley PhD candidate, from an online non-reply messaging service. This service is password protected. All messages will be standardised (not personally tailored) and will be focused on behaviour change techniques or reminders.
- Live exercise sessions: The researcher (with personal training and physical education teaching qualifications) will host two online group fitness classes each week which participants are also invited to join. This option is to allow participants the potential to engage with the other participants on the programme from the comfort of their own homes. It is also thought that having a scheduled set time to join a class on line may increase motivation and improve adherence, however the choice to join the class is optional. From previous feasibility work, these sessions were a highlight of the programme and often times parents and siblings would join in too. Participants are invited to turn their cameras on for the intro and warm up, however this is not mandatory.
- Access to a social media group: With participant and parental consent, participants are invited to join a private group community online where they can access additional resources provided by the research team, ask questions in an informal setting and communicate with the other participants in the programme. It is well researched that social connection is a facilitator to adolescent girls participation in physical activity and as participants will be exercising from home the investigators feel giving them access to a social, safe and virtual community can help give them this social connectedness to other adolescent girls of the same age. This is not compulsory and participants are free to join the group, leave the group or decline being added to the group without it affecting their participation in the rest of the programme.
- Individual behaviour change support:
- Participants in group 2 and 3 will be partnered with an 'activity mentor' whom they will work with for the duration of the intervention. These activity mentors are postgraduate students either studying for an MSc in sport and exercise psychology, or post-MSc and undertaking professional training. Their role is to support the participants with improving their health behaviours, autonomy and motivation. Participants will receive weekly calls from week 0-6 and then calls on week 9 and 12. Calls will be via phone call, FaceTime or Teams video call. Behaviour change support will be based on self-determination theory principles (autonomy, competence and relatedness; Ryan \& Deci, 2000). Each call will be based on a pre-planned session outline and will be goal orientated, participant centred and focused on physical activity. Calls are expected to last 10-20 minutes per participant. A sub-sample of calls will be audio recorded to assess intervention fidelity.
Control: menu of physical activity options only. As this project runs for 6 months it will not be possible to provide the control group with the full physical activity programme (this is part of a PhD study). However, it is intended to provide the control group participants with intervention materials (home-HIIT booklets, field-based testing instructions) so that participants can implement the physical activity programme without the direct oversight of the research team. At the end of the intervention, control participants will also be offered to do a group behaviour change psychology session with an activity mentor.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Using block randomisation on Microsoft Excel, participants will be assigned to one of the four groups following baseline measures
| Arm | Type | Receives |
|---|---|---|
| Menu of physical activity options | Experimental | Other: Behaviour changeParticipants in all 4 groups will receive this booklet with suggestions of ways to be physically active, e.g. YouTube workouts, cycling or jogging, sports, or design their own using a home-based exercise booklet. Participants are asked to do 3 exercise sessions of 30 minutes per week. Participants are asked to record what activity they did and the duration of the session using a method most convenient for them, e.g. notes on their phone, wall calendar or using an activity log template which we will provide. . |
| Physical activity programme | Experimental | Other: Behaviour changeParticipants in the second group with receive the activity menu (as described above) as well as a detailed physical activity programme. This programme includes supportive weekly text messages, access to live workouts and access to an online social community. |
| Individual behaviour change support | Experimental | Other: Behaviour changeParticipants in the third group with receive the activity menu (as described above) as well as individual behaviour change support. Each participant is partnered with a trainee sport psychology ("Activity Mentor") who they have weekly video calls with to support their health behaviour change. |
| Activity Programme & Behaviour Change Support | Experimental | Other: Behaviour changeParticipants in the fourth group will receive all of the above (exercise menu, live workouts, social community, support texts and weekly calls with an Activity Mentor). |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Female
- 13-16 years
- Living in the UK or Ireland
- Would like support with becoming more physically active
- Ability to participate in moderate intensity physical activity according to the Physical Activity Readiness Questionnaire
Key exclusion criteria (4 listed)
- Have taken part in previous HERizon study
- Currently doing more than 1 hour of exercise or sport every day.
- Currently pregnant
- Not having access to at least ONE of the following: a smartphone, home computer, or parent smartphone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviour changeUsing needs supportive, self-determination theory-based, components to improve the physical activity behaviours of adolescent girls. | Other | Activity Programme & Behaviour Change Support, Individual behaviour change support, Menu of physical activity options, Physical activity programme |
Primary outcome
Change in objective physical activity levels
Time frame: Baseline to post-intervention (week 12)
Participants objective PA will be monitored continuously (i.e. 24 h/day) over a nine-day period using an accelerometer (actigraph GT9x software). This device will be worn on their non-dominant wrist and uses the same validated MEMS sensor as the Actigraph GT3X+ model which has been validated (Hanggi et al., 2013) and used extensively with adolescents (Corder et al., 2016). Using the Actigraph, total daily PA, moderate-to-vigorous PA and sedentary time can be assessed.
8 secondary outcomes
Aerobic capacity
Time frame: week 0, week 12, week 24
Upper body strength
Time frame: week 0, week 12, week 24
Strength/ Power
Time frame: week 0, week 12, week 24
Change in Physical Activity Motivation
Time frame: week 0, week 12, week 24
Change in Body Appreciation
Time frame: week 0, week 12, week 24
Change in Physical Activity Competence
Time frame: week 0, week 12, week 24
Change in Self-esteeem
Time frame: week 0, week 12, week 24
Change in objective physical activity levels
Time frame: Baseline to follow-up (week 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 33430413Cowley ES, Watson PM, Foweather L, Belton S, Thompson A, Thijssen D, Wagenmakers AJM. "Girls Aren't Meant to Exercise": Perceived Influences on Physical Activity among Adolescent Girls-The HERizon Project. Children (Basel). 2021 Jan 7;8(1):31. doi: 10.3390/children8010031.
- Background: PubMed 33499174Cowley ES, Watson PM, Foweather L, Belton S, Mansfield C, Whitcomb-Khan G, Cacciatore I, Thompson A, Thijssen D, Wagenmakers AJM. Formative Evaluation of a Home-Based Physical Activity Intervention for Adolescent Girls-The HERizon Project: A Randomised Controlled Trial. Children (Basel). 2021 Jan 22;8(2):76. doi: 10.3390/children8020076.
- Individual participant dataSharing planned: No. We will use participant personal data in the ways needed to conduct and analyse the study and if necessary, to verify and defend, when required, the process and outcomes of the study. Personal data will be accessible to the study team. In addition, responsible members of Liverpool John Moores University be given access to personal data for monitoring and/or audit of the study to ensure that the study is complying with applicable regulations. When we do not need to use personal data, it will be deleted or identifiers will be removed. Consent form, contact details, audio recordings etc. will be retained for 10 years. We will not tell anyone that she has taken part in an interview. She will not be identifiable in any ensuing reports or publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Wagenmakers, PhD principal investigator
Liverpool John Moores University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour change in people with Exercise, run by Liverpool John Moores University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective physical activity levels (time frame: Baseline to post-intervention (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766372, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.