Condition category
Not Applicable
Date applied
08/01/2021
Date assigned
13/01/2021
Last edited
13/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.bhamcommunity.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

08/01/2021: Trial's existence confirmed by the NIHR.