Plain English Summary
Background and study aims
Many older adults are both highly sedentary (i.e. spending considerable amounts of leisure time sitting) and physically inactive (i.e. performing little physical activity). This study will try an intervention that centres on a theory-based leaflet giving recommendations for simple activities that can be done to both increase physical activity and displace or prevent sedentary behaviour. The recommendations are designed to promote habit formation, which theory suggests should bring behavioural gains over the long term.
Who can participate?
Participants aged 60-75 who are sedentary (i.e. spend 6 or more hours sitting per day) and inactive (i.e. do less than 30 cumulative minutes of at-least-moderate physical activity per week), with no physical impairments preventing increases in physical activity.
What does the study involve?
Each participant participates for a 12-week period. Potentially eligible patients are telephoned and asked to confirm their eligibility. They then attend their general practice to provide consent. At this session, participants are fitted with an accelerometer and invited to an initial measurement session at University College London in central London, UK. At the initial session, participants complete measures of sedentary behaviour and physical activity, habit, health and wellbeing. Participants are then randomly allocated to one of two groups. The intervention group receive the intervention leaflet and the control group an existing NHS factsheet outlining government recommendations for physical activity and sedentary behaviour but no information on specific activities to achieve these guidelines. After four weeks, participants are telephoned to arrange an 8-week follow-up measurement session. For the intervention group, this phone call also serve as an opportunity to offer additional motivational support or clarification to participants. At the 8-weeks session, participants complete follow-up measures of physical activity and sedentary behaviour, habit, health, and wellbeing. After 12 weeks, participants complete the same measures as above and are also interviewed about their experiences of the intervention and study procedures. All participants also wear sealed accelerometers (for measurement purposes) for one-week periods before the initial assessment and at 8 and 12 weeks later.
What are the possible benefits and risks of participating?
Participants in the intervention group are expected to benefit from increasing and maintaining their engagement in physical activity, and reducing time spent sitting, both of which are expected to lead to sustainable gains in health, wellbeing and functioning. There may also be gains for those in the control arm, given that they receive a leaflet advising on recommended levels of physical activity, and on reduction of sedentary behaviour. The financial and time burdens associated with attending measurement sessions, completing measures and participating in a study for 12 weeks are at least partly balanced by reimbursing participants' travel expenses (up to £20) incurred in attending each session, and giving them a £10 shopping voucher to thank them for helping us with assessment. Participants are also given a £30 shopping voucher, for the same reason, upon completion of the 12-week follow-up session, conditional upon their attending the 8- and 12-week follow-up sessions and returning the accelerometer. No adverse events are expected for participants. The intervention leaflet has been developed by experts, in collaboration with inactive older adults themselves, so that the activities it recommends are feasible and low risk, and may be performed at low levels of intensity, so as to reduce the potential for harm or injury. The control treatment is an existing NHS factsheet setting out physical activity and sedentary behaviour guidelines and poses minimal risk.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run?
April 2014 to February 2015
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Benjamin Gardner
b.gardner@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Benjamin Gardner
ORCID ID
Contact details
Department of Epidemiology and Public Health
University College London
Gower Street
London
WC1E 6BT
United Kingdom
-
b.gardner@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15919
Study information
Scientific title
Increasing physical activity in older adults: a randomised controlled pilot trial of a brief, habit-based intervention
Acronym
Study hypothesis
The primary aim of the study is to assess the feasibility of our intervention leaflet (designed to reduce sedentary behaviour and increase physical activity) and our study procedures, as a basis for informing sample size calculations and procedures for a future definitive randomised controlled trial.
The secondary aim is to assess changes in sedentary behaviour, physical activity, habits, and health.
Ethics approval
First MREC approval date 03/12/2013, 13/LO/1549
Study design
Randomised; Interventional; Design type: Prevention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Primary Care Research Network for England, Generic Health Relevance and Cross Cutting Themes; Subtopic: Not Assigned, Generic Health Relevance (all Subtopics); Disease: All Diseases
Intervention
Control treatment: A control group will receive an NHS factsheet setting out government recommendations for physical activity, and (minimising) sedentary behaviour.
'On Your Feet' intervention: This intervention centres on a leaflet offering ten tips for simple behaviours that can be adopted to reduce sitting time and increase physical activity, and increase physical activity habit strength. It also includes 'ticksheets' to allow participants to track their adherence to the tips.
Follow Up Length: 3 month(s); Study Entry : Registration and One or More Randomisations
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Recruitment and attrition rates; Timepoint(s): Study entry, baseline, 8 weeks, 12 weeks
Secondary outcome measures
1. Physical activity; Timepoint(s): Baseline, 8 weeks, 12 weeks
2. Physical activity habit strength; Timepoint(s): Baseline, 8 weeks, 12 weeks
3. Physical health; Timepoint(s): Baseline, 8 weeks, 12 weeks
4. Sedentary behaviour; Timepoint(s): Baseline, 8 weeks, 12 weeks
5. Sedentary behaviour habit strength; Timepoint(s): Baseline, 8 weeks, 12 weeks
6. Wellbeing; Timepoint(s): Baseline, 8 weeks, 12 weeks
Overall trial start date
01/04/2014
Overall trial end date
27/02/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 60-75 years
2. Retired
3. Inactive (<30 consecutive minutes of leisure time physical activity of at least 3 METs per week)
4. Sedentary (>6 total leisure time hours sitting per day)
5. Able to speak and read English
6. Able to provide full informed consent for themselves
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120; Description: 60 intervention patients, 60 controls
Participant exclusion criteria
1. Reporting a disabling impairment which prevents them from engaging in regular light physical activity
2. Currently participating, or has participated in the previous 3 months, in a physical activity promotion or sedentary behaviour reduction study
3. Unable to provide informed consent due to mental incapacity or active psychotic illness
4. Terminally ill
5. Aged under 60 or over 75 years at time of first contact
6. Insufficient comprehension of English
Recruitment start date
01/04/2014
Recruitment end date
27/02/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) - National Prevention Research Initiative; Grant Codes: MR/J000396/1
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25240737
2015 updated protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26242218
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28491459