Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial
The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) p...
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creator | Hardeman, Wendy Mitchell, Joanna Pears, Sally Van Emmenis, Miranda Theil, Florence Gc, Vijay S Vasconcelos, Joana C Westgate, Kate Brage, Søren Suhrcke, Marc Griffin, Simon J Kinmonth, Ann Louise Wilson, Edward C F Prevost, A Toby Sutton, Stephen |
description | The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care.
The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that |
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The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment.
In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up.
Current Controlled Trials (ISRCTN72691150).</description><identifier>ISSN: 1549-1676</identifier><identifier>ISSN: 1549-1277</identifier><identifier>EISSN: 1549-1676</identifier><identifier>DOI: 10.1371/journal.pmed.1003046</identifier><identifier>PMID: 32142507</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Actigraphy - economics ; Actigraphy - instrumentation ; Adult ; Aged ; Blood pressure ; Cardiovascular disease ; Clinical trials ; Cost analysis ; Cost-Benefit Analysis ; Engineering and Technology ; England ; Epidemiology ; Exercise ; Female ; Fidelity ; Fitness Trackers - economics ; Funding ; Health Care Costs ; Health economics ; Healthy Lifestyle ; Healthy Volunteers ; Humans ; Informed consent ; Intervention ; Male ; Medicine and Health Sciences ; Middle Aged ; People and Places ; Physical activity ; Physical training ; Primary care ; Primary Health Care - economics ; Public health ; Research and Analysis Methods ; Research parks ; Social Sciences ; Software ; State Medicine - economics ; Time Factors</subject><ispartof>PLoS medicine, 2020-03, Vol.17 (3), p.e1003046-e1003046</ispartof><rights>2020 Hardeman et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2020 Hardeman et al 2020 Hardeman et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c526t-875e84ea3c60e29577efaa1630be66afca5093eb4d2ac63c765727a2a8cafd763</citedby><cites>FETCH-LOGICAL-c526t-875e84ea3c60e29577efaa1630be66afca5093eb4d2ac63c765727a2a8cafd763</cites><orcidid>0000-0003-1723-0796 ; 0000-0002-6498-9407 ; 0000-0003-0365-2605 ; 0000-0002-0283-3562 ; 0000-0002-1265-7355 ; 0000-0001-7709-4058 ; 0000-0002-6417-1402 ; 0000-0002-2157-4797 ; 0000-0001-7263-8626 ; 0000-0003-2138-3402 ; 0000-0002-8369-1577</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059905/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059905/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79569,79570</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32142507$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hardeman, Wendy</creatorcontrib><creatorcontrib>Mitchell, Joanna</creatorcontrib><creatorcontrib>Pears, Sally</creatorcontrib><creatorcontrib>Van Emmenis, Miranda</creatorcontrib><creatorcontrib>Theil, Florence</creatorcontrib><creatorcontrib>Gc, Vijay S</creatorcontrib><creatorcontrib>Vasconcelos, Joana C</creatorcontrib><creatorcontrib>Westgate, Kate</creatorcontrib><creatorcontrib>Brage, Søren</creatorcontrib><creatorcontrib>Suhrcke, Marc</creatorcontrib><creatorcontrib>Griffin, Simon J</creatorcontrib><creatorcontrib>Kinmonth, Ann Louise</creatorcontrib><creatorcontrib>Wilson, Edward C F</creatorcontrib><creatorcontrib>Prevost, A Toby</creatorcontrib><creatorcontrib>Sutton, Stephen</creatorcontrib><creatorcontrib>VBI Research Team</creatorcontrib><creatorcontrib>on behalf of the VBI Research Team</creatorcontrib><title>Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial</title><title>PLoS medicine</title><addtitle>PLoS Med</addtitle><description>The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care.
The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment.
In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up.
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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><collection>PLoS Medicine</collection><jtitle>PLoS medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hardeman, Wendy</au><au>Mitchell, Joanna</au><au>Pears, Sally</au><au>Van Emmenis, Miranda</au><au>Theil, Florence</au><au>Gc, Vijay S</au><au>Vasconcelos, Joana C</au><au>Westgate, Kate</au><au>Brage, Søren</au><au>Suhrcke, Marc</au><au>Griffin, Simon J</au><au>Kinmonth, Ann Louise</au><au>Wilson, Edward C F</au><au>Prevost, A Toby</au><au>Sutton, Stephen</au><aucorp>VBI Research Team</aucorp><aucorp>on behalf of the VBI Research Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial</atitle><jtitle>PLoS medicine</jtitle><addtitle>PLoS Med</addtitle><date>2020-03-01</date><risdate>2020</risdate><volume>17</volume><issue>3</issue><spage>e1003046</spage><epage>e1003046</epage><pages>e1003046-e1003046</pages><issn>1549-1676</issn><issn>1549-1277</issn><eissn>1549-1676</eissn><abstract>The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care.
The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment.
In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up.
Current Controlled Trials (ISRCTN72691150).</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>32142507</pmid><doi>10.1371/journal.pmed.1003046</doi><orcidid>https://orcid.org/0000-0003-1723-0796</orcidid><orcidid>https://orcid.org/0000-0002-6498-9407</orcidid><orcidid>https://orcid.org/0000-0003-0365-2605</orcidid><orcidid>https://orcid.org/0000-0002-0283-3562</orcidid><orcidid>https://orcid.org/0000-0002-1265-7355</orcidid><orcidid>https://orcid.org/0000-0001-7709-4058</orcidid><orcidid>https://orcid.org/0000-0002-6417-1402</orcidid><orcidid>https://orcid.org/0000-0002-2157-4797</orcidid><orcidid>https://orcid.org/0000-0001-7263-8626</orcidid><orcidid>https://orcid.org/0000-0003-2138-3402</orcidid><orcidid>https://orcid.org/0000-0002-8369-1577</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 1549-1676 |
ispartof | PLoS medicine, 2020-03, Vol.17 (3), p.e1003046-e1003046 |
issn | 1549-1676 1549-1277 1549-1676 |
language | eng |
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source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Public Library of Science (PLoS) |
subjects | Actigraphy - economics Actigraphy - instrumentation Adult Aged Blood pressure Cardiovascular disease Clinical trials Cost analysis Cost-Benefit Analysis Engineering and Technology England Epidemiology Exercise Female Fidelity Fitness Trackers - economics Funding Health Care Costs Health economics Healthy Lifestyle Healthy Volunteers Humans Informed consent Intervention Male Medicine and Health Sciences Middle Aged People and Places Physical activity Physical training Primary care Primary Health Care - economics Public health Research and Analysis Methods Research parks Social Sciences Software State Medicine - economics Time Factors |
title | Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial |
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