Plain English Summary
Background and study aims:
There is strong evidence that being active and sitting less is important for health. Guidance states that adults should, over a week, complete at least 150 minutes of moderate to vigorous-intensity physical activity (30 minutes per/day) in periods of 10 minutes or more. However, few people manage this which puts their health at risk. This is concerning and new ways are needed to help people to be active daily. The reason why so few people are meeting the current physical activity guidance may be because they have to make big changes to their lifestyle, which can be too difficult. An alternative is an idea we have called Snacktivity. Rather than encouraging people to do 30 minutes of physical activity each day in one go, or in 10-minute periods, snacktivity focuses on encouraging people to do small physical activity ‘snacks’, throughout the day so they achieve 150 minutes of activity per/week. The aim of this study is to assess the feasibility and acceptability of the Snacktivity intervention.
Who can participate?
80 inactive adults who are eligible to receive an NHS Health Check from general practices (East and West Midlands), and from services offered by Birmingham Community Healthcare NHS Foundation Trust (BCHC)
What does the study involve?
Participants will be randomly allocated to receive standard advice about physical activity (large changes) or encouragement to achieve their physical activity by Snacktivity (small changes). The researchers will promote Snacktivity in the intervention group by giving participants a physical activity tracker to help monitor their Snacktivity and overall physical activity, and access to an App called SnackApp that prompts people to participate in Snacktivity. The researchers will measure physical activity at the start of the study and 12 weeks later.
What are the possible benefits and risks of participating?
It is hoped that the intervention will encourage participants to be more physically active which may improve their health. The researchers do not expect any risks from taking part in this study.
Where is the study run from?
1. Loughborough University (UK)
2. University of Birmingham Clinical Trials Unit (UK)
3. University of Leicester (UK)
When is the study starting and how long is it expected to run for?
August 2018 to June 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Amanda Daley
a.daley@lboro.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Amanda Daley
ORCID ID
http://orcid.org/0000-0002-4866-8726
Contact details
National Centre for Sport and Exercise Medicine (NCSEM)
School of Sport
Exercise and Health Science
Epinal Way
Loughborough
LE11 3TU
United Kingdom
+44 (0)1509 226353
a.daley@lboro.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 46654, IRAS ID 285836
Study information
Scientific title
Snacktivity to promote physical activity and reduce future risk of disease in the population (work package 3 – feasibility trial)
Acronym
Study hypothesis
The aim of work package 3 is to undertake a randomised feasibility trial with nested qualitative interviews to assess the feasibility and acceptability of the Snacktivity intervention.
Ethics approval
Approval pending, West Midlands – Edgbaston Research Ethics Committee (Royal College of Surgeons Edinburgh, Birmingham B3 2BB, UK; +44 (0)20 7104 8112, +44 (0)207 104 8019, +44 (0)2071048089; edgbaston.rec@hra.nhs.uk)
Study design
Randomized; Interventional; Design type: Treatment, Education or Self-Management, Device, Other
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Physical activity
Intervention
Participants will be randomised to receive standard advice about physical activity (large changes) or encouragement to achieve their physical activity by Snacktivity (small changes). The researchers will promote Snacktivity in the intervention group by giving participants a physical activity tracker to help monitor their Snacktivity and overall physical activity, and access to an App called SnackApp that prompts people to participate in Snacktivity. The researchers will measure physical activity at the start of the study and 12 weeks later.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The feasibility of a subsequent phase III randomised controlled trial (RCT) according to pre-specified progression criteria. The researchers are primarily interested in whether:
1. The trial is appealing to participants (assessed by the recruitment rate)
2. The Snacktivity intervention is acceptable (measured by Snacktivity adherence)
They also wish to assess:
3. The recruitment and randomisation processes
4. The extent of any intervention contamination
These are all measured at the end of the trial.
Secondary outcome measures
1. Moderate-vigorous physical activity measured using a research-grade wrist-worn accelerometer at baseline and 12-week follow up
2. Light physical activity measured using a research-grade wrist-worn accelerometer at baseline and after 12-week follow up
3. Total physical activity measured using a research-grade wrist-worn accelerometer at baseline and 12-week follow up
4. Sedentary time measured using a research-grade wrist-worn accelerometer at baseline and at 12-week follow up
5. Sleep time measured using a research-grade wrist-worn accelerometer at baseline and at 12-week follow up
Other outcomes include:
1. Self-reported sedentary behaviours measured using the workforce Sitting Questionnaire (WSQ)) and International Physical Activity Questionnaire (IPAQ) at baseline and 12-week follow up
2. Lower limb muscle strength measured using a Takei dynamometer at baseline and 12-week follow up
3. Weight measured using SECA scales at baseline and 12-week follow up
4. Waist circumference measured using a tape measure at baseline and 12-week follow up
5. Blood pressure measured using a blood pressure monitor at baseline and 12-week follow up
6. Depression/anxiety measured using the Hospital Anxiety and Depression Scale at baseline and 12-week follow up
Overall trial start date
01/08/2018
Overall trial end date
30/06/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Inactive (i.e. defined as not in employment or doing a sedentary job, AND completing less than 1 h of physical exercise, walking or cycling per week as measured by the General Practice Physical Activity Questionnaire (GPPAQ))
2. Eligible for an NHS Health Check or have an appointment scheduled at one of the selected community health services detailed above
3. Able to provide informed written consent
4. Aged ≥18 years (all routes of recruitment)
5. Own a mobile phone capable of hosting apps (Apple and Android)
6. Agreement for their health care professional (HCP) to be notified of participant involvement in this study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 80; UK Sample Size: 80
Participant exclusion criteria
1. Unable to understand English sufficiently to complete the trial assessments
2. Women known to be pregnant or breastfeeding
Recruitment start date
01/03/2021
Recruitment end date
30/07/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The centres taking part are unknown at the time of registration
-
United Kingdom
Sponsor information
Organisation
Birmingham Community Healthcare NHS Trust
Sponsor details
3 Priestley Wharf
Holt Street
Birmingham Science Park
Aston
Birmingham
B7 4BN
United Kingdom
+44 (0)1214666000
research.innovation@bhamcommunity.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0618-20008
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. Additional files are not available.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/06/2024
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list