NCT04325399

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 25, 2020

Last Update Submit

March 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gym attendance

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

    Gym attendance was recorded over 12 months from baseline

Study Arms (2)

Planning

EXPERIMENTAL

The 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.

Other: Volitional help sheet

No planning

NO INTERVENTION

Participants 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.

Interventions

Also known as: VHS
Planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 16361448BACKGROUND
  • 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.

    PMID: 16415256BACKGROUND
  • 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.

    PMID: 24656134BACKGROUND
  • 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.

    PMID: 16905727BACKGROUND
  • 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.

    PMID: 20309777BACKGROUND
  • Bélanger-Gravel A, Godin G & Amireault, S. A meta-analytic review of the effect of implementation intentions on physical activity. Health Psychology Review. 2013; 7(1): 23-54.

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

    PMID: 15781105BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 12900694BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Chris Armitage, PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miss

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

April 1, 2016

Primary Completion

November 2, 2016

Study Completion

November 2, 2016

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share