Condition category
Not Applicable
Date applied
03/10/2012
Date assigned
05/10/2012
Last edited
10/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Physical activity can delay or prevent chronic diseases such as vascular disease, which includes heart disease, stroke, diabetes and kidney disease. The majority of adults in England do not meet the government recommendation of at least 30 minutes per day of moderate-intensity activity on at least five days per week. The NHS is conducting Health Checks, in which everyone between 40 and 74 years is invited for an assessment of their risk of vascular disease and offered appropriate management of risk. The Health Checks are an ideal opportunity to deliver brief interventions to promote physical activity to large numbers of people. The present study forms part of a larger programme of on-going (and inter-related) research, funded by an NIHR Programme Grant, which aims to develop and evaluate very brief interventions to increase physical activity in primary care. In the present study we will test several ‘brief’ interventions which aim to promote physical activity that could be delivered by a practice nurse or health care assistants (HCA) in five minutes during a Health Check consultation. It is anticipated that the findings of the present study will indicate what intervention should be selected (out of the several brief interventions piloted in the present study) to be taken forward for robust evaluation in a larger study.

Who can participate?
Adults aged 40-74 who are invited for an NHS Health Check (The NHS Health Checks are designed for adults who have not been previously diagnosed with vascular disease).

What does the study involve?
In Phase 1, the nurse (or HCA) will pilot each intervention within the Health Check consultation. The consultations will be audio-taped to check fidelity to the intervention protocol and the time taken to deliver the intervention. Participants will be interviewed immediately after the consultation by a researcher to assess the acceptability of the intervention. In Phase 2, the nurse (or HCA) will deliver 1 intervention per week (these will be refined and modified based on the findings of Phase 1). Feasibility, fidelity and acceptability will be assessed as in Phase 1 using audio-tapes of consultations and interviews with the nurses/HCAs and a random sample participants. The outcome measures, assessed at 4 weeks (post intervention), will be objective physical activity (assessed by accelerometers), self-reported physical activity and relevant mediators.

What are the possible benefits and risks of participating?
Physical activity can delay or prevent chronic diseases such as vascular disease (which includes heart disease, stroke, diabetes and kidney disease). By providing patients with advice on how to become more active, they could improve their health. The potential risks to participants in this study will be negligible. The interventions used in the study are behaviour change interventions that aim to encourage moderate physical activity such as brisk walking which carries a very low risk of injury.

Where is the study run from?
The Primary Care Unit, University of Cambridge (UK)

When is study starting and how long is it expected to run for?
October 2012 to December 2013

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Katie Morton
km576@medschl.cam.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katie Morton

ORCID ID

Contact details

Primary Care Unit
University Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223 331271
km576@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13157

Study information

Scientific title

Potential efficacy, fidelity, feasibility and acceptability of techniques to promote physical activity for use in very brief interventions in primary care: a feasibilty study

Acronym

Study hypothesis

The objective of this research is to test several ‘brief’ interventions which aim to promote physical activity, that could be delivered by a practice nurse (PN) or healthcare assistant (HCA) in five minutes during a Health Check consultation. Initially, the interventions will be piloted in a small number of practices in order to assess their feasibility, acceptability and fidelity, via recordings of consultations and through interviews with PNs (or HCAs) and participants. Following this, the interventions will be tested in a randomised controlled trial whereby PNs (or HCAs) will deliver different interventions to participants within the Health Checks, in order to determine whether these brief interventions increase participants’ physical activity levels four weeks after the Health Check. It is anticipated that the findings of the present study will indicate what intervention should be selected (out of the several brief interventions piloted in the present study) to be taken forward for robust evaluation in a larger explanatory trial.

Ethics approval

Cambridge Central, 25/04/2012, ref: 12/EE/0200

Study design

Both; 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

Promoting physical activity

Intervention

Phase 1:
Participants will receive ‘usual care’ for NHS Health Check PLUS one of four brief behaviour change interventions for increasing physical activity:
1. Brief motivational intervention OR
2. Action-planning intervention OR
3. Pedometer intervention OR
4. Activity diary (self-monitoring) intervention

Phase 2: (Up to) Eight groups to be compared
Control Group: Participants will receive ‘usual care’ for NHS Health Check

Intervention Group: Participants will receive ‘usual care’ for NHS Health Check PLUS one of (up to) seven brief behaviour change interventions to increase physical activity:
1. Brief motivational intervention OR
2. Action-planning intervention OR
3. Pedometer intervention OR
4. Activity diary (self-monitoring) intervention OR
5-7 A combination of intervention

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Phase 1
Fidelity of the intervention delivery by the PN (or HCA) e.g. adherence to protocol, competency

Secondary outcome measures

Phase 2
Physical activity (assessed by self-report questionnaire and accelerometer counts per day)

Overall trial start date

17/09/2012

Overall trial end date

01/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be adults aged 40-74 who are invited for an NHS Health Check (The NHS Health Checks are designed for adults who have not been previously diagnosed with vascular disease).

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 600; UK Sample Size: 600

Participant exclusion criteria

As this study is a feasibility trial to pilot and test several interventions, participants who do not have a working knowledge of English (and thus cannot participate in an interview without the aid of a translator) will also be excluded from the study.

Recruitment start date

17/09/2012

Recruitment end date

01/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Unit
Cambridge
CB2 0SR
United Kingdom

Sponsor information

Organisation

University of Cambridge (UK)

Sponsor details

Addenbrookes Centre for Clinical Investigation (ACCI)
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR (UK) - Central Commissioning Facility (CCF)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25887643
2015 erratum in: http://www.ncbi.nlm.nih.gov/pubmed/26577404
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27716297

Publication citations

Additional files

Editorial Notes

03/10/2016: Publication reference added. 20/04/2016: Publication reference added.