Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial

Robert J Petrella, Kuni Aizawa, Kevin Shoemaker, Tom Overend, Len Piche, Mauricio Marin, Sheree Shapiro, Sophie Atkin, Robert J Petrella, Kuni Aizawa, Kevin Shoemaker, Tom Overend, Len Piche, Mauricio Marin, Sheree Shapiro, Sophie Atkin

Abstract

Background: Previous interventions to increase physical activity and reduce cardiovascular risk factors have been targeted at individuals with established disease; less attention has been given to intervention among individuals with high risk for disease nor has there been determination of the influence of setting in which the intervention is provided. In particular, family practice represents an ideal setting for the provision and long-term maintenance of lifestyle interventions for patients at risk (ie high-normal blood pressure or impaired glucose tolerance).

Methods/design: The Staged Nutrition and Activity Counseling (SNAC) study is a randomized clustered design clinical trial that will investigate the effectiveness and efficacy of a multi-component lifestyle intervention on cardiovascular disease risk factors and vascular function in patients at risk in primary care. Patients will be randomized by practice to either a standard of care lifestyle intervention or a behaviourally-based, matched prescriptive physical activity and diet change program. The primary goal is to increase physical activity and improve dietary intake according to Canada's Guides to Physical Activity Healthy Eating over 24 months. The primary intention to treat analysis will compare behavioral, physiological and metabolic outcomes at 6, 12 and 24 months post-randomization including estimation of incident hypertension and/or diabetes.

Discussion: The design features of our trial, and the practical problems (and solutions) associated with implementing these design features, particularly those that result in potential delay between recruitment, baseline data collection, randomization, intervention, and assessment will be discussed. Results of the SNAC trial will provide scientific rationale for the implementation of this lifestyle intervention in primary care.

Trial registration: ISRCTN: ISRCTN:42921300.

References

    1. US Preventive Services Task Force. Behavioral counseling in primary care to promote physical activity: Recommendation and rationale. Ann Intern Med. 2002;137:205–207.
    1. Nathan DM, Meigs J, Singer DE. The epidemiology of cardiovascular disease in type 2 diabetes mellitus: how sweet it is... or is it? Lancet. 1997;350:4–9.
    1. Vassan RS, Beiser A, Seshadri S, Larson MG, Kannel WB, D'Agostino RB, Levy D. Residual lifetime risk for development of hypertension in middle-aged men and women. The Framingham Heart Study. JAMA. 2002;287:1003–1010.
    1. Diabetes Prevention Program Research Group. Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin. N Engl J Med. 2002;346(6):393–403.
    1. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M. Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344(18):1343–1350.
    1. Borhani NO. Significance of physical activity for prevention and control of hypertension. J Hum Hypertens. 1996;10(Suppl):S7–S11.
    1. The Trials of Hypertension Collaborative Research Group. The effects of nonpharmacologic interventions on blood pressure of persons with high-normal levels: Results of the Trials of Hypertension Prevention, Phase I (TOHP-I) JAMA. 1992;267:1213–1220.
    1. Schappert SM, Nelson C. National Ambulatory Medical care Survey: 1995-96 Summary. Vital and health statistics. Washington, D.C.: Government Printing Office; 1999. Series 13. No. 142. (DHHS publication no. (PHS) 2000-1713.)
    1. Aromaa A, Reunanen A, Pyorala K. Hypertension and mortality in diabetic and nondiabetic Finnish men. J Hypertens. 1984;2:S205–S207.
    1. Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-year cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993;16:434–444.
    1. Wannamethee SG, Shapes AG. Physical activity in the prevention of cardiovascular disease: An epidemiological perspective. Sports Med. 2001;31:101–114.
    1. Marteau TM, Kinmonth AL. Screening for cardiovascular risk: public health imperitive or matter of individual informed choice? BMJ. 2002;325:78–80.
    1. Stamler J. Setting the TONE for ending the hypertension epidemic. JAMA. 1998;279:878–879.
    1. Wee CC, McCarthy EP, Davis RB, Phillips RS. Physician counseling about exercise. JAMA. 1999;282:1583–1588.
    1. Petrella RJ, Lattanzio CN. Does counseling help patients get active? Systematic review of the literature. Can Fam Physician. 2002;48:72–80.
    1. Petrella RJ, Lattanzio CN, Overend T. Physical Activity Counseling and Prescription among Canadian Family Physicians. Arch Intern Med. 2007;167:1774–1781.
    1. Williford HN, Barfield BR, Lazenby RB, Scharff Olson MS. A survey of physician's attitudes and practices related to exercise promotion. Prev Med. 1992;21:630–636.
    1. Orleans CT, George LK, Houpt JL, Brodie KH. Health promotion in primary care: a survey of U.S. family practitioners. Prev Med. 1985;14:636–647.
    1. Petrella RJ, Wight D. An office-based instrument for exercise counseling and prescription in primary care. The Step Test Exercise Prescription (STEP) Arch Fam Med. 2000;9(4):339–344.
    1. Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002;137:208–215.
    1. Lenfant C. Reflections on hypertension control rates. A message from the Director of the National Heart, Lung, and Blood Institute. Arch Intern Med. 2002;162:131–132.
    1. Chockalingam A, Campbell N, Ruddy T, Taylor G, Stewart P. (for the expert working group) Canadian national high blood pressure prevention and control strategy. Can J Cardiol. 2000;16:1087–1093.
    1. Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Sceppa C, White RD. Physical activity/exercise and type 2 diabetes: a consensus statement from the American Diabetes Association. Diabetes Care. 2006;29:1433–1438.
    1. Sacks FM, Svetkey LP, Vollmer WM. Effects on blood pressure of reduced salt and the Dietary Approaches to Stop Hypertension (DASH) diet. N Engl J Med. 2001;344:3–10.
    1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jones DW, Materson BJ, Oparil S, Wright JT. National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289:2560–2572.
    1. Khan NA, McAlister FA, Rabkin SW, Padwal R, Feldman RD, Campbell NR, Leiter LA, Lewanczuk RZ, Schiffrin EL, Hill MD, Arnold M, Moe G, Campbell TS, Herbert C, Milot A, Stone JA, Burgess E, Hemmelgarn B, Jones C, Larochelle P, Ogilvie RI, Houlden R, Herman RJ, Hamet P, Fodor G, Carruthers G, Culleton B, Dechamplain J, Pylypchuk G, Logan AG, Gledhill N, Petrella R, Tobe S, Touyz RM. Canadian Hypertension Education Program. The 2006 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 Therapy. Can J Cardiol. 2006;22:583–593.
    1. King AC, Sallis JF, Dunn AL, Simons-Morton DG, Albright CA, Overview of the Activity Counseling Trial (ACT) intervention for promoting physical activity in primary health care settings. American College of Sports Medicine. 1998. pp. 1086–1096.
    1. VanSliujs EMF, van Poppel MNM, van Mechelen W. Stage-based lifestyle interventions in primary care: Are they effective? Am J Prev Med. 2004;26:330–343.
    1. Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: Toward an integrated model of change. J Consult Clin Psychol. 1983;51:390–395.
    1. VanSliujs EMF, van Poppel MNM, Twisk JWR, Chin A, Paw MJ, Calfas KKJ, van Mechelen W. Effect of a tailored physical activity intervention delivered in general practice settings: Results of a randomized controlled trial. Am J Public Health. 2005;95:1825–1831.
    1. Goldstein MG, Pinto BM, Marcus BH, Lynn H, Jette AM, Rakowski W, McDermott S, DePue JD, Milan FB, Dubé C, Tennstedt S. Physician-based physical activity counseling for middle-aged and older adults: a randomized trial. Ann Behav Med. 1999;21(1):40–47.
    1. Norris SL, Grothaus LC, Buchner DM, Pratt M. Effectivness of physician-based assessment and counseling for exercise in a staff model HMO. Prev Med. 2000;30(6):513–523.
    1. Calfas KJ, Long BJ, Sallis JF, Wooten WJ, Pratt M, Patrick K. A controlled trial of physician counseling to promote the adoption of physical activity. Prev Med. 1996;25(3):225–233.
    1. Dunn AL, Marcus BH, Kampert JB, Garcia ME, Kohl HW III, Blair SN. Reduction in cardiovascular disease risk factors: 6 month results from Project Active. Prev Med. 1997;26:883–892.
    1. Havlik RJ, Phillips CL, Brock DB, Lohman K, Haskell W, Snell P, O'Toole M, Ribisl P, Vaitkevicius P, Spurgeon HA, Lakatta EG, Pullenh P. Walking may be related to less vascular stiffness in the Activity Counseling Trial (ACT) Am Heart J. 2005;150:270–5.
    1. Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002;347:1483–1492.
    1. Petrella RJ, Kovall JJ, Cunningham DA, Paterson DH. Can primary care doctors prescribe exercise to improve fitness? The Step Test Exercise Prescription (STEP) Project. Am J Prev Med. 2003;24(4):316–322.
    1. Petrella RJ, Merikle E, Jones J. Prevalence, treatment and control of hypertension in primary care: gaps, trends and opportunities. J Clin Hypertens. 2007;9:28–35.
    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;29(2):158–162.
    1. Franklin BA, editor. American College of Sports Medicine. ACSM's guidelines for exercise testing and prescription. 6. Baltimore, Maryland: Lippincott Williams & Wilkins; 2000.
    1. Atkin S, Manley J, Petrella RJ. Development and validation of a stage-matched nutrition lifestyle intervention for primary care physicians. Med Sci Sports Exerc. 2005;37:S368. (1919)
    1. Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. Adherence to a Mediterranean diet and survival in a Greek population. N Engl J Med. 2003;348:2599–608.
    1. Petrella RJ, Koval JJ, Cunningham DA, Paterson DH. A self-paced step test to predict aerobic fitness in older adults in the primary care clinic. JAGS. 2001;49:632–638.
    1. Health Canada. Statistics Canada, Canadian Community Health Survey 2006/07. accessed at on June 1, 2008.
    1. Petrella RJ, Lattanzio CN, Overend T. Effects of a physician-based exercise counseling program for improving aerobic fitness in older adults. Can Fam Phys. 2010;56:e191–200.
    1. Cook NR, Cohen JC, Hebert PR, Taylor JO, Hennekens CH. Implications of small reductions in diastolic blood pressure for primary prevention. Arch Intern Med. 1995;155:701–709.
    1. Chobanian AV. Control of hypertension-an important national priority. N Engl J Med. 2001;345:534–535.
    1. Green LA. Prescription for health. Ann Fam Med. 2005;3(Suppl 2):S2–S3.
    1. Williams PT. Physical fitness and activity as separate heart disease risk factors: a meta-analysis. Med Sci Sports Exerc. 2001;33:754–761.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe