Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients

Zakkoyya H Lewis, Kenneth J Ottenbacher, Steve R Fisher, Kristofer Jennings, Arleen F Brown, Maria C Swartz, Elizabeth J Lyons, Zakkoyya H Lewis, Kenneth J Ottenbacher, Steve R Fisher, Kristofer Jennings, Arleen F Brown, Maria C Swartz, Elizabeth J Lyons

Abstract

Background: Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users.

Objective: The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer.

Methods: Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders.

Results: The study started recruitment in October 2015 and is scheduled to be completed by October 2016.

Conclusions: This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level.

Trial registration: ClinicalTrials.gov NCT02554435; https://ichgcp.net/clinical-trials-registry/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT).

Keywords: 5 A counseling; activity monitors; cardiovascular disease; intervention; physical activity; prevention; primary care; technology.

Conflict of interest statement

Conflicts of Interest: While the AHA funded this study, MCS's spouse has an equity interest in Apple Inc, a company that may potentially benefit from the research results. UTMB’s Conflicts of Interest Committee has reviewed this equity interest and a management plan implemented to prevent any appearance of a conflict of interest. Any inquiries regarding this management plan can be directed to UTMB's Office of Institutional Compliance, (409) 747-8701.

Figures

Figure 1
Figure 1
Conceptual framework of the intervention.

References

    1. Mozaffarian D, Benjamin E, Go A. Heart disease and stroke statistics-- American: A report from the Heart Association. Circulation. 2015;131(4); 2015. pp. e29–322.
    1. Luckhaupt SE, Calvert GM, Centers for Disease Control and Prevention Prevalence of coronary heart disease or stroke among workers aged <55 years--United States, 2008-2012. MMWR Morb Mortal Wkly Rep. 2014 Aug 1;63(30):645–649.
    1. Lloyd-Jones DM, Hong Y, Labarthe D, Mozaffarian D, Appel LJ, Van HL, Greenlund K, Daniels S, Nichol G, Tomaselli GF, Arnett DK, Fonarow GC, Ho PM, Lauer MS, Masoudi FA, Robertson RM, Roger V, Schwamm LH, Sorlie P, Yancy CW, Rosamond WD, American Heart Association Strategic Planning Task Force and Statistics Committee Defining and setting national goals for cardiovascular health promotion and disease reduction: The American Heart Association's strategic impact goal through 2020 and beyond. Circulation. 2010 Feb 2;121(4):586–613. doi: 10.1161/CIRCULATIONAHA.109.192703.
    1. Ahmed HM, Blaha MJ, Nasir K, Rivera JJ, Blumenthal RS. Effects of physical activity on cardiovascular disease. Am J Cardiol. 2012 Jan 15;109(2):288–295. doi: 10.1016/j.amjcard.2011.08.042.
    1. McGavock JM, Eves ND, Mandic S, Glenn NM, Quinney HA, Haykowsky MJ. The role of exercise in the treatment of cardiovascular disease associated with type 2 diabetes mellitus. Sports Med. 2004;34(1):27–48.
    1. Perez-Terzic CM. Exercise in cardiovascular diseases. PM R. 2012 Nov;4(11):867–873. doi: 10.1016/j.pmrj.2012.10.003.
    1. Swift DL, Lavie CJ, Johannsen NM, Arena R, Earnest CP, O'Keefe JH, Milani RV, Blair SN, Church TS. Physical activity, cardiorespiratory fitness, and exercise training in primary and secondary coronary prevention. Circ J. 2013;77(2):281–292.
    1. Vanhees L, De SJ, Gelada S, Doyle F, Prescott E, Cornelissen V, Kouidi E, Dugmore D, Vanuzzo D, Börjesson M, Doherty P, EACPR Importance of characteristics and modalities of physical activity and exercise in defining the benefits to cardiovascular health within the general population: Recommendations from the EACPR (Part I) Eur J Prev Cardiol. 2012 Aug;19(4):670–686. doi: 10.1177/2047487312437059.
    1. Ströbl Veronika, Knisel W, Landgraf U, Faller H. A combined planning and telephone aftercare intervention for obese patients: Effects on physical activity and body weight after one year. J Rehabil Med. 2013 Feb;45(2):198–205. doi: 10.2340/16501977-1095.
    1. Spring B, Ockene JK, Gidding SS, Mozaffarian D, Moore S, Rosal MC, Brown MD, Vafiadis DK, Cohen DL, Burke LE, Lloyd-Jones D, American Heart Association Behavior Change Committee of the Council on Epidemiology and Prevention‚ Council on Lifestyle and Cardiometabolic Health‚ Council for High Blood Pressure Research‚ Council on Cardiovascular and Stroke Nursing Better population health through behavior change in adults: A call to action. Circulation. 2013 Nov 5;128(19):2169–2176. doi: 10.1161/01.cir.0000435173.25936.e1.
    1. Sun F, Norman IJ, While AE. Physical activity in older people: A systematic review. BMC Public Health. 2013;13:449. doi: 10.1186/1471-2458-13-449.
    1. Teixeira PJ, Carraça EV, Markland D, Silva MN, Ryan RM. Exercise, physical activity, and self-determination theory: A systematic review. Int J Behav Nutr Phys Act. 2012;9:78. doi: 10.1186/1479-5868-9-78.
    1. Goldstein MG, Whitlock EP, DePue J, Planning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project Multiple behavioral risk factor interventions in primary care. Summary of research evidence. Am J Prev Med. 2004 Aug;27(2 Suppl):61–79. doi: 10.1016/j.amepre.2004.04.023.
    1. Jacobson DM, Strohecker L, Compton MT, Katz DL. Physical activity counseling in the adult primary care setting: Position statement of the American College of Preventive Medicine. Am J Prev Med. 2005 Aug;29(2):158–162. doi: 10.1016/j.amepre.2005.04.009.
    1. Bock C, Diehl K, Schneider S, Diehm C, Litaker D. Behavioral counseling for cardiovascular disease prevention in primary care settings: A systematic review of practice and associated factors. Med Care Res Rev. 2012 Oct;69(5):495–518. doi: 10.1177/1077558712441084.
    1. Berra K, Rippe J, Manson J. Making physical activity counseling a priority in clinical practice: The time for action is now. JAMA. 2015;314(24):2617–2618. doi: 10.1001/jama.2015.16244.
    1. Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care behavioral counseling interventions: An evidence-based approach. Am J Prev Med. 2002 May;22(4):267–284.
    1. Fortier MS, Hogg W, O'Sullivan TL, Blanchard C, Reid RD, Sigal RJ, Boulay P, Doucet E, Sweet S, Bisson E, Beaulac J. The physical activity counselling (PAC) randomized controlled trial: Rationale, methods, and interventions. Appl Physiol Nutr Metab. 2007 Dec;32(6):1170–1185. doi: 10.1139/H07-075.
    1. Vansteenkiste M, Williams GC, Resnicow K. Toward systematic integration between self-determination theory and motivational interviewing as examples of top-down and bottom-up intervention development: Autonomy or volition as a fundamental theoretical principle. Int J Behav Nutr Phys Act. 2012;9:23. doi: 10.1186/1479-5868-9-23.
    1. Diehl K, Mayer M, Mayer F, Görig Tatiana, Bock C, Herr RM, Schneider S. Physical activity counseling by primary care physicians: Attitudes, knowledge, implementation, and perceived success. J Phys Act Health. 2015 Feb;12(2):216–223. doi: 10.1123/jpah.2013-0273.
    1. van AT, Huisman-de Waal Getty G J. Ketelaar Nicole A B M. Oostendorp RA, Jacobs JE, Wollersheim Hub C H How to promote healthy behaviours in patients? An overview of evidence for behaviour change techniques. Health Promot Int. 2011 Jun;26(2):148–162. doi: 10.1093/heapro/daq050.
    1. Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: A meta-regression. Health Psychol. 2009 Nov;28(6):690–701. doi: 10.1037/a0016136.
    1. Verwey R, van der Weegen Sanne. Spreeuwenberg M, Tange H, van der Weijden Trudy. de WL. A monitoring and feedback tool embedded in a counselling protocol to increase physical activity of patients with COPD or type 2 diabetes in primary care: Study protocol of a three-arm cluster randomised controlled trial. BMC Fam Pract. 2014;15:93. doi: 10.1186/1471-2296-15-93.
    1. Knight E, Stuckey MI, Petrella RJ. Health promotion through primary care: Enhancing self-management with activity prescription and mHealth. Phys Sportsmed. 2014 Sep;42(3):90–99. doi: 10.3810/psm.2014.09.2080.
    1. Thomas JG, Bond DS. Review of innovations in digital health technology to promote weight control. Curr Diab Rep. 2014;14(5):485. doi: 10.1007/s11892-014-0485-1.
    1. Knight JA. Physical inactivity: Associated diseases and disorders. Ann Clin Lab Sci. 2012;42(3):320–337.
    1. Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: A systematic review. JAMA. 2007 Nov 21;298(19):2296–2304. doi: 10.1001/jama.298.19.2296.
    1. Cayir Y, Aslan SM, Akturk Z. The effect of pedometer use on physical activity and body weight in obese women. Eur J Sport Sci. 2015;15(4):351–356. doi: 10.1080/17461391.2014.940558.
    1. Richardson CR, Newton TL, Abraham JJ, Sen A, Jimbo M, Swartz AM. A meta-analysis of pedometer-based walking interventions and weight loss. Ann Fam Med. 2008;6(1):69–77. doi: 10.1370/afm.761.
    1. Miyazaki R, Kotani K, Tsuzaki K, Sakane N, Yonei Y, Ishii K. Effects of a year-long pedometer-based walking program on cardiovascular disease risk factors in active older people. Asia Pac J Public Health. 2015 Mar;27(2):155–163. doi: 10.1177/1010539513506603.
    1. Freak-Poli R, Wolfe R, Brand M, de CM, Peeters A. Eight-month postprogram completion: Change in risk factors for chronic disease amongst participants in a 4-month pedometer-based workplace health program. Obesity (Silver Spring) 2013 Sep;21(9):E360–368. doi: 10.1002/oby.20342.
    1. Aittasalo M, Miilunpalo S, Kukkonen-Harjula K, Pasanen M. A randomized intervention of physical activity promotion and patient self-monitoring in primary health care. Prev Med. 2006 Jan;42(1):40–46. doi: 10.1016/j.ypmed.2005.10.003.
    1. Bonomi AG, Westerterp KR. Advances in physical activity monitoring and lifestyle interventions in obesity: A review. Int J Obes (Lond) 2012 Feb;36(2):167–177. doi: 10.1038/ijo.2011.99.
    1. Aittasalo M, Miilunpalo S, Kukkonen-Harjula K, Pasanen M. A randomized intervention of physical activity promotion and patient self-monitoring in primary health care. Prev Med. 2006 Jan;42(1):40–46. doi: 10.1016/j.ypmed.2005.10.003.
    1. Franklin NC, Lavie CJ, Arena RA. Personal health technology: A new era in cardiovascular disease prevention. Postgrad Med. 2015 Mar;127(2):150–158. doi: 10.1080/00325481.2015.1015396.
    1. Danova T. Just 3 million fitness trackers were sold in the US in the past year. [2016-02-24]. .
    1. Lewis ZH, Lyons EJ, Jarvis JM, Baillargeon J. Using an electronic activity monitor system as an intervention modality: A systematic review. BMC Public Health. 2015;15:585. doi: 10.1186/s12889-015-1947-3.
    1. Lyons EJ, Lewis ZH, Mayrsohn BG, Rowland JL. Behavior change techniques implemented in electronic lifestyle activity monitors: A systematic content analysis. J Med Internet Res. 2014;16(8):e192. doi: 10.2196/jmir.3469.
    1. Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: The CALO-RE taxonomy. Psychol Health. 2011 Nov;26(11):1479–1498. doi: 10.1080/08870446.2010.540664.
    1. Normansell R, Smith J, Victor C, Cook Derek G, Kerry Sally, Iliffe Steve, Ussher Michael, Fox-Rushby Julia, Whincup Peter, Harris Tess. Numbers are not the whole story: A qualitative exploration of barriers and facilitators to increased physical activity in a primary care based walking intervention. BMC Public Health. 2014;14:1272. doi: 10.1186/1471-2458-14-1272.
    1. Patel M, Asch D, Volpp K. Wearable devices as facilitators, not drivers, of health behavior change. JAMA. 2015 Feb 3;313(5):459–460. doi: 10.1001/jama.2014.14781.
    1. Carroll JK, Winters PC, Sanders MR, Decker F, Ngo T, Sciamanna CN. Clinician-targeted intervention and patient-reported counseling on physical activity. Prev Chronic Dis. 2014;11:E89. doi: 10.5888/pcd11.130302.
    1. Adams M, Sallis J, Norman G, Hovell M, Hekler E, Perata E. An adaptive physical activity intervention for overweight adults: A randomized controlled trial. PLoS One. 2013;8(12):e82901. doi: 10.1371/journal.pone.0082901.
    1. Task Force on Community Preventive Services Recommendations to increase physical activity in communities. Am J Prev Med. 2002 May;22(4 Suppl):67–72.
    1. Williams SL, French DP. What are the most effective intervention techniques for changing physical activity self-efficacy and physical activity behaviour--and are they the same? Health Educ Res. 2011 Apr;26(2):308–322. doi: 10.1093/her/cyr005.
    1. Olander EK, Fletcher H, Williams S, Atkinson L, Turner A, French DP. What are the most effective techniques in changing obese individuals' physical activity self-efficacy and behaviour: A systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2013;10:29. doi: 10.1186/1479-5868-10-29.
    1. Warburton D, Jamnik V, Bredin S, Gledhill N. The physical activity readiness questionnaire (PAR-Q+) and electronic physical activity readiness medical examination (ePARmed-X+). Health Fitness Journal Canada. 2011. Collaboration P-QR .
    1. Smith A. 2014. [2016-02-24]. Older adults and technology use
    1. Yasunaga A, Togo F, Watanabe E, Park H, Park S, Shephard RJ, Aoyagi Y. Sex, age, season, and habitual physical activity of older Japanese: The Nakanojo study. J Aging Phys Act. 2008 Jan;16(1):3–13.
    1. Urbaniak G, Plous S. Research randomizer. 1999. [2016-02-25]. Research randomizer
    1. Yamax Accessed September 30. 2015. [2016-02-24]. Digi-Walker CW-700/701 .
    1. Dolan B. mobihealth news. 2014. [2016-02-24]. Fitbit, Jawbone, Nike had 97 percent of fitness tracker retail sales in 2013
    1. Jawbone Jawbone. 2015. [2016-02-23]. The UP system .
    1. Vandelanotte C, De BI. Acceptability and feasibility of a computer-tailored physical activity intervention using stages of change: Project FAITH. Health Educ Res. 2003 Jun;18(3):304–317.
    1. Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: A prospective structural equation analysis. Ann Behav Med. 2002;24(2):149–156.
    1. D'Agostino R, Vasan R, Pencina M. 2015. Accessed October. 2015. [2016-02-25]. Cardiovascular disease (10-year risk) .
    1. Rikli R, Jones C. Journal of Aging and Physical Activity. 1998. The Reliability and validity of a 6-minute walk test as a measure of physical endurance in older adults .
    1. Kaminsky LA, Arena R, Beckie TM, Brubaker PH, Church TS, Forman DE, Franklin BA, Gulati M, Lavie CJ, Myers J, Patel MJ, Piña Ileana L, Weintraub WS, Williams MA, American Heart Association Advocacy Coordinating Committee‚ Council on Clinical Cardiology‚ Council on Nutrition‚ Physical Activity and Metabolism The importance of cardiorespiratory fitness in the United States: The need for a national registry: A policy statement from the American Heart Association. Circulation. 2013 Feb 5;127(5):652–662. doi: 10.1161/CIR.0b013e31827ee100.
    1. Widmer RJ, Collins NM, Collins CS, West CP, Lerman LO, Lerman A. Digital health interventions for the prevention of cardiovascular disease: A systematic review and meta-analysis. Mayo Clin Proc. 2015 Apr;90(4):469–480. doi: 10.1016/j.mayocp.2014.12.026.
    1. D'Agostino R, Vasan R, Pencina M, Wolf Philip A, Cobain Mark, Massaro Joseph M, Kannel William B. General cardiovascular risk profile for use in primary care: The Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743–753. doi: 10.1161/CIRCULATIONAHA.107.699579.
    1. Rikli R. Senior fitness test manual. IL: Champaign, IL; Human Kinetics; 2013.
    1. Berntsen S, Hageberg R, Aandstad A, Mowinckel P, Anderssen SA, Carlsen K, Andersen LB. Validity of physical activity monitors in adults participating in free-living activities. Br J Sports Med. 2010 Jul;44(9):657–664. doi: 10.1136/bjsm.2008.048868.
    1. Seca Accessed October 7. 2015. [2016-02-24]. seca 213 .
    1. Tanita Tanita. 2014. [2016-02-24]. BWB-800S Doctors scale
    1. NIH Accessed October 7. 2015. [2016-02-24]. Calculate your body mass index .
    1. Taylor RW, Jones IE, Williams SM, Goulding A. Evaluation of waist circumference, waist-to-hip ratio, and the conicity index as screening tools for high trunk fat mass, as measured by dual-energy X-ray absorptiometry, in children aged 3-19 y. Am J Clin Nutr. 2000 Aug;72(2):490–495.
    1. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 AC (HEM-7322-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision. Dublin: dablEducational Trust; 2014. [2016-02-25].
    1. Jenkinson C, Wright L, Coulter A. Criterion validity and reliability of the SF-36 in a population sample. Qual Life Res. 1994 Feb;3(1):7–12.
    1. Freiberger E, de VP, Schoene D, Rydwik E, Mueller V, Frändin Kerstin, Hopman-Rock M. Performance-based physical function in older community-dwelling persons: A systematic review of instruments. Age Ageing. 2012 Nov;41(6):712–721. doi: 10.1093/ageing/afs099.
    1. Cella D, Gershon R, Bass M, Rothrock N. Promis. 2013. [2016-02-23]. Assessment center .
    1. Markland D. BREQ-2 home; Accessed April 8. 2013. [2016-02-24]. BREQ and BREQ-2 scoring .
    1. Wilson PM, Todd Rogers W, Rodgers WM, Wild TC. Journal of Sport & Exercise Psychology. 2006. The psychological need satisfaction in exercise scale .
    1. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA Statement. Open Med. 2009;3(3):e123–130.
    1. Wadden TA, Volger S, Sarwer DB, Vetter ML, Tsai AG, Berkowitz RI, Kumanyika S, Schmitz KH, Diewald LK, Barg R, Chittams J, Moore RH. A two-year randomized trial of obesity treatment in primary care practice. N Engl J Med. 2011 Nov 24;365(21):1969–1979. doi: 10.1056/NEJMoa1109220.
    1. Harris T, Kerry SM, Victor CR, Ekelund Ulf, Woodcock Alison, Iliffe Steve, Whincup Peter H, Beighton Carole, Ussher Michael, Limb Elizabeth S, David Lee, Brewin Debbie, Adams Fredrika, Rogers Annabelle, Cook Derek G. A primary care nurse-delivered walking intervention in older adults: PACE (pedometer accelerometer consultation evaluation)-Lift cluster randomised controlled trial. PLoS Med. 2015 Feb;12(2):e1001783. doi: 10.1371/journal.pmed.1001783.
    1. Pfaeffli DL, Whittaker R, Jiang Y, Stewart R, Rolleston A, Maddison R. Text message and internet support for coronary heart disease self-management: Results from the Text4Heart randomized controlled trial. J Med Internet Res. 2015;17(10):e237. doi: 10.2196/jmir.4944.
    1. Braun V, Clarke V. What can "thematic analysis" offer health and wellbeing researchers? Int J Qual Stud Health Well-being. 2014;9:26152.
    1. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464–475. doi: 10.1016/j.jclinepi.2008.12.011.
    1. Stevens J, Taber DR, Murray DM, Ward DS. Advances and controversies in the design of obesity prevention trials. Obesity (Silver Spring) 2007 Sep;15(9):2163–2170. doi: 10.1038/oby.2007.257.
    1. Kang M, Marshall SJ, Barreira TV, Lee J. Effect of pedometer-based physical activity interventions: A meta-analysis. Res Q Exerc Sport. 2009 Sep;80(3):648–655. doi: 10.1080/02701367.2009.10599604.
    1. Sherson EA, Yakes JE, Katalanos N. A review of the use of the 5 A's model for weight loss counselling: Differences between physician practice and patient demand. Fam Pract. 2014 Aug;31(4):389–398. doi: 10.1093/fampra/cmu020.
    1. Kwong Enid Wai-Yung, Kwan Alex Yui-Huen. Participation in health-promoting behaviour: Influences on community-dwelling older Chinese people. J Adv Nurs. 2007 Mar;57(5):522–534. doi: 10.1111/j.1365-2648.2006.04132.x.

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