A trial to investigate the impact of a Christmas-themed physical activity intervention during advent on participation in physical activity and sedentary behaviour: Active Advent
| ISRCTN | ISRCTN12415556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12415556 |
| Secondary identifying numbers | 6057 |
- Submission date
- 29/09/2021
- Registration date
- 11/11/2021
- Last edited
- 20/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Many people do not do enough aerobic-based physical activity and only 1% of the UK population do sufficient amounts of muscle-strengthening physical activity. Given the health benefits of participation in all types of physical activity, it is important to develop novel interventions to increase people’s physical activity levels. The Christmas holiday period is a high-risk time for physical inactivity and an increased amount of time spent sitting. The aim of this study is to test an intervention that aims to increase physical activity in the public during the Christmas holiday period.
Who can participate?
Adults aged 18 years or over, who have access to emails, currently live in the UK and report participating in no more than 75 minutes per week of moderate-to-vigorous intensity physical activity.
What does the study involve?
Participants are randomly allocated to one of two groups. Those allocated to group one will receive one email each day between 1st and 24th of December that will include ideas for Christmas-themed physical activities. Those allocated to group two will receive written information about the importance of physical activity for health via email at the start of December.
What are the possible benefits and risks of participating?
Participating in regular physical activity may improve health and well-being. This study involves very little risk to participants. Wearing an accelerometer can cause mild skin irritation. To prevent this, participants will be encouraged to remove the accelerometer daily to clean the skin underneath the device, and to switch wrists if necessary.
Where is the study run from?
Loughborough University (UK)
When is the study starting and how long is it expected to run for?
June 2021 to January 2022
Who is funding the study?
The National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Gregory Biddle, g.j.biddle@lboro.ac.uk
Contact information
Scientific
Sir John Beckwith Building
Loughborough University
Loughborough
LE11 3TU
United Kingdom
 ORCID ID |
0000-0002-4394-0655 |
|---|---|
| Phone | +44 (0)1509 228483 |
| g.j.biddle@lboro.ac.uk |
Public
Sir John Beckwith Building
Loughborough University
Loughborough
LE11 3TU
United Kingdom
| Phone | +44 (0)1509 228483 |
|---|---|
| g.j.biddle@lboro.ac.uk |
Study information
| Study design | Pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | 40495_PIS_V1.1.pdf |
| Scientific title | A pilot randomised controlled trial to investigate the effects of a Christmas-themed physical activity intervention during advent on participation in physical activity and sedentary behaviour: Active Advent |
| Study acronym | Active Advent |
| Study objectives | The Active Advent intervention will increase self-reported moderate-to-vigorous physical activity more than the comparator group. |
| Ethics approval(s) | Approved 11/11/2021, Loughborough University Human Participants Sub-Committee (Hazlerigg Building, Research & Enterprise Office, Loughborough University, Loughborough, LE11 3TU, UK, +44 (0)1509 222423, LEON@lboro.ac.uk), ref: 6057 |
| Health condition(s) or problem(s) studied | Inactive adults |
| Intervention | Unequal randomisation will be used to ensure a 2:1 ratio in favour of the intervention group. Randomisation will be done sequentially. The intervention will consist of a daily physical activity idea over each of the 24 days of advent which will be sent to participants via email (or via SMS) each day. Each activity idea will be divided into three levels of difficulty, and from which participants can select: Easy Elf (low intensity), Moderate Mince Pie (moderate intensity and Strenuous Santa (vigorous intensity). Participants are free to change the difficulty of their activity each day. The duration of each Active Advent physical activity idea will vary and will be determined by the activity type and anticipated intensity (for example, a Strenuous Santa activity may be shorter than an Easy Elf activity due to the higher intensity). Participants randomised to the comparator group will receive a healthy living leaflet. This will be sent once on or around 1st of December. |
| Intervention type | Behavioural |
| Primary outcome measure | Moderate-to-vigorous intensity physical activity measured using the exercise vital signs questionnaire at baseline, week 1, week 2 and week 3 of the intervention period |
| Secondary outcome measures | 1. Muscle-strengthening physical activity measured using the exercise vital signs questionnaire at baseline, week 1, week 2 and week 3 of the intervention period 2. Moderate-to-vigorous intensity physical activity measured with an accelerometer at baseline and towards the end of the intervention period 3. Total physical activity measured with an accelerometer at baseline and towards the end of the intervention period 4. Sedentary behaviour measured with an accelerometer at baseline and towards the end of the intervention period 5. Adherence to the intervention measured with an online survey at week 1, week 2 and week 3 and at the end of the intervention period 6. Enjoyment of the intervention measured with an online survey at week 1, week 2 and week 3 and at the end of the intervention period |
| Overall study start date | 01/06/2021 |
| Completion date | 31/01/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 105 |
| Total final enrolment | 107 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Access to email 3. Currently living in the UK 4. Completing ≤75 minutes of moderate‐to‐vigorous physical activity (MVPA) per week |
| Key exclusion criteria | 1. Unable to understand and communicate in English 2. Pre-existing condition that inhibits their ability to stand or be physically active |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School for Sport, Exercise and Health Science
National Centre for Sport and Exercise Medicine
Loughborough
LE11 3TU
United Kingdom
Sponsor information
University/education
Research & Enterprise Office
Loughborough
LE11 3TU
England
United Kingdom
| Phone | +44 (0)1509 222222 |
|---|---|
| Researchpolicy@lboro.ac.uk | |
| Website | http://www.lboro.ac.uk/ |
"ROR" |
https://ror.org/04vg4w365 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Once the study is completed, the researchers plan to publish the findings in a peer-reviewed journal. Participants will not be identified in any way in the study publications. The results may also be presented at scientific conferences and or meetings. A summary of the study findings will be posted on a Loughborough University website within 12 months after the end of the study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. Anonymous data will be stored securely at Loughborough University for up to 10 years after the end of the study, at which time it will be deleted. Identifiable data will be deleted at the end of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 07/10/2021 | No | Yes | |
| Protocol file | version 1.1 | 07/10/2021 | No | No | |
| Results article | 19/12/2022 | 20/12/2022 | Yes | No |
Additional files
Editorial Notes
20/12/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
11/02/2022: The ethics approval was added.
02/11/2021: Trial's existence confirmed by Loughborough University Ethics Review Sub-committee.
