AzTrials
AzTrials

Physical ActivityNCT04325399

A Randomised Controlled Trial of a Brief Planning Intervention to Promote Physical Activity

A study testing Volitional help sheet in people with Physical Activity, run by University of Manchester.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

People of low socioeconomic status are more inclined to incur poor health than those of high socioeconomic status. Different factors have been attributed to contributing to such health inequalities, including differences in modifiable lifestyle factors. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Volitional help sheet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
No sites listed yet
Study dates
1 Apr 2016to 2 Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 or over
  • Newly registered gym members
  • Be able to speak English

Who cannot join

  • Adults with an obvious learning difficulty that means they were unable to understand the purpose of the study and what was asked of them as they would not be able to provide informed consent.
  • Adults who have been a gym member in the past 12 months preceding the study

About this study

People of low socioeconomic status are more inclined to incur poor health than those of high socioeconomic status. Different factors have been attributed to contributing to such health inequalities, including differences in modifiable lifestyle factors. For example, people of high socioeconomic status are more likely to engage in greater levels of physical activity, and are more inclined to adhere and take up population-level behaviour change interventions. Subsequently, there has been a call to create more targeted interventions designed to especially target people with low socioeconomic status.

Socioeconomic status represents availability and access to resources, and measures that are broadly divided into individual measures such as income, education and occupational status, and area-level or neighbourhood deprivation measures. However, while socioeconomic status is a multifaceted concept, there is a tendency in research to use a single measure (such as either income or education level) interchangeably to capture the full scope of socioeconomic status. This is based upon the assumption that one socioeconomic measure taps into the underlying features of another aspect of socioeconomic status, despite little being known about the effect each socioeconomic status measure has upon physical activity intervention outcomes.

Therefore the purpose of this study is to consider the effect the different measures of socioeconomic status, specifically income, occupational status, education and area deprivation, have upon the effectiveness of an established implementation intentions-based intervention (the volitional helpsheet) designed to increase physical activity.

Read the detailed description

Detailed Description A health gap exists such that people of low socioeconomic status are more inclined to incur poor health than those of high socioeconomic status (Marmot, 2005). Differences in modifiable lifestyle factors between high- and low-socioeconomic groups, such as differences in physical activity levels, have been implemented in contributing to this health gap. Additionally, interventions created to redress this health gap can unintentionally have the reverse effect of increasing health inequalities as more affluent individuals are more likely to take up and adhere to behaviour change interventions, thus creating intervention-generated inequalities (White et al., 2009). Subsequently, there has been an increased call for interventions designed to promote healthy lifestyle behaviours, including physical activity, to be targeted towards specific groups of individuals including people with low-socioeconomic status (White et al., 2009). However, socioeconomic status is typically operationalised using a single measure such as educational status, yet socioeconomic status represents availability of and access to resources (Psaki et al., 2014), including those that access physical activity.

Socioeconomic measures can broadly be categorised as individual level factors, such as income, education and occupation, and area-level indicators or neighbourhood deprivation indices (Galobardes et al., 2006a, 2006b) such as the Index of Multiple Deprivation. While each measure captures a specific aspect of socioeconomic status, having its own relative strengths and limitations, there is a tendency in research to use a single measure (such as either income or education level) interchangeably to capture the full scope of socioeconomic status (Geyer et al., 2006). This is based upon the assumption that one socioeconomic measure taps into the underlying features of another aspect of socioeconomic status, despite little being known about the effect each socioeconomic status measure has upon physical activity intervention outcomes.

The purpose of this study is to consider the effect the different measures of socioeconomic status, specifically income, occupational status, education and area deprivation, have upon the effectiveness of an established implementation intentions-based intervention (the volitional help sheet) designed to increase physical activity and which has been shown to increase physical activity among manual workers (Armitage \& Arden, 2010).

This study will seek to address the following research questions;

  1. Does the volitional help sheet (VHS) increase gym attendance among new gym registrants?
  2. Does the way in which socioeconomic status is measured moderate the effects of the volitional help sheet on gym attendance between low and high -income, - education, -occupation and -area deprivation groups?

Method A two-armed randomised controlled trial design was used. Participants were randomised into either the intervention or control condition using an online random number generator.

Participants A sample size calculation was conducted using evidence from Belanger-Gravel et al., (2013) in their meta-analysis examining the effects of implementation intentions on physical activity. Assuming an effect size of 0.24 (α = 0.05), the study was powered to 90%, giving a desired sample size of 786 participants (384 participants per group). However, the desired sample size was not achieved. Subsequently, a total of 118 adult participants (aged 18 years or older) were recruited from leisure centres in deprived areas of a city located in the North West of England. The final total sample size was 98 due to issues associated with missing values of some key socioeconomic status variables.

Procedure New leisure centre members were invited to take part in the study by either the researcher or a staff member. Each participant was provided with a participant information sheet, and asked to complete a consent form before completing the questionnaire which had been randomised in advance. It was explained to each participant in writing that their gym attendance was be tracked for 12-months using their electronic gym entry swipes. Each questionnaire was identical, differing only in the instructions on how to complete the volitional help sheet.

Intervention The volitional help sheet is a psychological tool based on implementations intentions, which helps the formation of "if-then" plans. This helps individuals to translate motivation into behavioural action. "If-then" plans are created when an individual links a critical situation in memory ("if") with an appropriate behavioural response ("then") (Armitage and Arden, 2010). In this way "if-then" plans enable an individual to automatically initiate the specified behavioural response when the environmental cue is encountered (Armitage and Arden, 2010). The volitional help sheet is comprised of two lists; one of critical situations that challenge participants to being physically active (e.g. "If I'm tempted not to go to the gym because it's cold outside"), and the other appropriate behavioural solutions (e.g. "then I will make myself go to the gym anyway because I know I will feel better afterward". In the present study, the intervention group participants are required to draw a line to between relevant critical situations and solutions to create "if-then" plans. The control group receive the exact same volitional help sheet, the only difference being that participants are instructed to tick relevant critical situations and solutions.

Measures Demographic information including gender, age and ethnicity was taken in addition to the following measures.

Gym attendance - Gym attendance for each participant was measured electronically by tracking gym entry swipes. Gym attendance was obtained for 12-months from when the baseline questionnaire was completed. As each participant is required to attend a mandatory induction session to access the gym suite, this session was discounted from the total attendance.

Physical activity - The short form International Physical activity Questionnaire (IPAQ-SF) (Craig et al., 2003) was used to obtain a self-reported measure of physical activity.

The following socioeconomic status measures were taken; Area deprivation - Each participants post-code was used to obtain an area deprivation score using the English Indices of Multiple Deprivation (IMD, 2015) which was then grouped to obtain a decile ranking.

Household Income - was assessed using the Living Costs and Food survey (LCFS, 2014). Accordingly, participants were asked to select which income band from eleven represents there household income. Income bands increase by £100 increments and range from "Less than £100 per week" to "Over £1000 per week".

Occupational Status - An adapted version of the National Statistics Socioeconomic Classification NS-SEC method (NS-SEC 2010) was used to obtain a measure of occupational status for each participant. Participants were initially asked to indicate their employments status from six options including "employed", "self-employed" and "student", and to state their most recent or current job role and what it entails. Participant job titles were then mapped onto the NS-SEC coding framework to derive an occupation code, which was used to establish an NS-SEC analytic and operational category for each participant.

Education - was measured using the qualification questions obtained from the UK Census 2011. Participants were required to indicate, from a list of qualifications ("1 - 4 O levels / CSEs / GCSEs (any grade), Entry Level, Foundation Diploma", "Apprenticeship", "Degree (for example BA, BSc), higher degree (for example MA, PhD, PGCE" and "No qualifications") every qualification that applied to them from the list. Participants were instructed to tick the nearest equivalent qualification if their UK qualification was not listed. For those participants who had acquired qualifications outside of the UK, they were instructed to tick "Foreign Qualifications" and then the nearest UK equivalent qualification, if known.

Statistical Analysis Randomisation success of the total sample was evaluated using multivariate analysis of variance (MANOVA).

A one-way between groups analysis of variance (ANOVA) was used to assess the effectiveness of the volitional help sheet upon total gym attendance during the 12-month study period between the experimental and control groups. Two way between-group ANOVA's were used to evaluate the direct and indirect effects of each socioeconomic measure of income, education, occupation and area deprivation upon gym attendance between both the experimental and control conditions.

Being tested
Volitional help sheet
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volitional help sheetOther

    Also called VHS

Study groups in NCT04325399
Study groupRoleWhat they receive
PlanningExperimentalThe volitional help sheet (VHS) comprises of a list of challenges to being physically active (e.g. "If I'm tempted not to go to the gym because it's cold outside") and a list of possible ways to overcome thes (e.g. "then I will make myself go to the gym anyway because I know I will feel better afterward"). In the experimental VHS link group, participants are asked to form "if-then" plans by drawing a line between challenges and solutions to link them together.
Receives: Other: Volitional help sheet
No planningNo interventionParticipants in the VHS tick group are presented with the exact same volitional help sheet as the experimental group, the only difference being that participants in this group are not asked to make if-then plans. Rather, participants in the control group are asked to tick challenges and solutions that they feel are relevant to them.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gym attendance

    Attendance of participants at a leisure centre/gym recorded using electronic entry swipes

    Measured: Gym attendance was recorded over 12 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start1 Apr 2016
  3. Primary completion2 Nov 2016
  4. Study completion2 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04325399
Sponsor's protocol ID
Brief Planning Intervention PA
Status last verified
Mar 2020
First submitted
25 Mar 2020
Last updated
27 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Galobardes B, Shaw M, Lawlor DA, Lynch JW, Davey Smith G. Indicators of socioeconomic position (part 1). J Epidemiol Community Health. 2006 Jan;60(1):7-12. doi: 10.1136/jech.2004.023531.

    PubMed 16361448
  • Galobardes B, Shaw M, Lawlor DA, Lynch JW, Davey Smith G. Indicators of socioeconomic position (part 2). J Epidemiol Community Health. 2006 Feb;60(2):95-101. doi: 10.1136/jech.2004.028092.

    PubMed 16415256
  • Psaki SR, Seidman JC, Miller M, Gottlieb M, Bhutta ZA, Ahmed T, Ahmed AS, Bessong P, John SM, Kang G, Kosek M, Lima A, Shrestha P, Svensen E, Checkley W; MAL-ED Network Investigators. Measuring socioeconomic status in multicountry studies: results from the eight-country MAL-ED study. Popul Health Metr. 2014 Mar 21;12(1):8. doi: 10.1186/1478-7954-12-8.

    PubMed 24656134
  • Geyer S, Hemstrom O, Peter R, Vagero D. Education, income, and occupational class cannot be used interchangeably in social epidemiology. Empirical evidence against a common practice. J Epidemiol Community Health. 2006 Sep;60(9):804-10. doi: 10.1136/jech.2005.041319.

    PubMed 16905727
  • Armitage CJ, Arden MA. A volitional help sheet to increase physical activity in people with low socioeconomic status: A randomised exploratory trial. Psychol Health. 2010 Dec;25(10):1129-45. doi: 10.1080/08870440903121638.

    PubMed 20309777
  • Belanger-Gravel A, Godin G, Bilodeau A, Poirier P. The effect of implementation intentions on physical activity among obese older adults: a randomised control study. Psychol Health. 2013;28(2):217-33. doi: 10.1080/08870446.2012.723711. Epub 2012 Sep 24.

    PubMed 23005579
  • Marmot M. Social determinants of health inequalities. Lancet. 2005 Mar 19-25;365(9464):1099-104. doi: 10.1016/S0140-6736(05)71146-6.

    PubMed 15781105
  • White M, Adams J, Heywood P. How and why do interventions that increase health overall widen inequalities within populations? In Babones S (Ed.). Health, inequality and society. Bristol: Policy Press (2009).

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

Questions about this trial

What is this clinical trial studying?

A study testing Volitional help sheet in people with Physical Activity, run by University of Manchester.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gym attendance (time frame: Gym attendance was recorded over 12 months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325399, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in