Condition category
Mental and Behavioural Disorders
Date applied
16/01/2014
Date assigned
16/01/2014
Last edited
06/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
We are seeking to recruit 120 participants aged 60-75 years, with no physical impairments preventing increases in physical activity. Participants will also be 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). Participants will be recruited via their local general practice.

What does the study involve?
Each participant will participate for a 12-week period. Potentially eligible patients will be telephoned and asked to confirm their eligibility. They will then attend their general practice to provide consent. At this session, participants will be fitted with an accelerometer and invited to an initial measurement session at University College London in central London, UK. At the initial session, participants will complete measures of sedentary behaviour and physical activity, habit, health and wellbeing. Participants will then be randomly allocated to one of two groups. The intervention group will 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 will be telephoned to arrange an 8-week follow-up measurement session. For the intervention group, this phone call will also serve as an opportunity to offer additional motivational support or clarification to participants. At the 8-weeks session, participants will complete follow-up measures of physical activity and sedentary behaviour, habit, health, and wellbeing. After 12 weeks, participants will complete the same measures as above and will also be interviewed about their experiences of the intervention and study procedures. All participants will 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 arm 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 will 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 twelve weeks will be 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. We will also give participants 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. We expect no adverse events among study 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?
All study procedures will be carried out from University College London, UK.

When is the study starting and how long is it expected to run?
The study is due to start in April 2014 and is expected to end in February 2015.

Who is funding the study?
The study is funded by the Medical Research Council (UK).

Who is the main contact?
Dr Benjamin Gardner
b.gardner@ucl.ac.uk
+44 (0)20 7679 8267

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 below 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 measures

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

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25240737
2015 updated protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26242218

Publication citations

Additional files

Editorial Notes