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BMC Public Health
Published in: BMC Public Health 1/2015

Open Access 01-12-2015 | Study protocol

Physical activity promotion in the primary care setting in pre- and type 2 diabetes - the Sophia step study, an RCT

Authors: Jenny Rossen, Agneta Yngve, Maria Hagströmer, Kerstin Brismar, Barbara E. Ainsworth, Christina Iskull, Peter Möller, Unn-Britt Johansson

Published in: BMC Public Health | Issue 1/2015

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Abstract

Background

Physical activity prevents or delays progression of impaired glucose tolerance in high-risk individuals. Physical activity promotion should serve as a basis in diabetes care. It is necessary to develop and evaluate health-promoting methods that are feasible as well as cost-effective within diabetes care. The aim of Sophia Step Study is to evaluate the impact of a multi-component and a single component physical activity intervention aiming at improving HbA1c (primary outcome) and other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes.

Methods/design

Sophia Step Study is a randomized controlled trial and participants are randomly assigned to either a multi-component intervention group (A), a pedometer group (B) or a control group (C). In total, 310 patients will be included and followed for 24 months. Group A participants are offered pedometers and a website to register steps, physical activity on prescription with yearly follow-ups, motivational interviewing (10 occasions) and group consultations (including walks, 12 occasions). Group B participants are offered pedometers and a website to register steps. Group C are offered usual care. The theoretical framework underpinning the interventions is the Health Belief Model, the Stages of Change Model, and the Social Cognitive Theory. Both the multi-component intervention (group A) and the pedometer intervention (group B) are using several techniques for behavior change such as self-monitoring, goal setting, feedback and relapse prevention.
Measurements are made at week 0, 8, 12, 16, month 6, 9, 12, 18 and 24, including metabolic and cardiovascular biomarkers (HbA1c as primary health outcome), accelerometry and daily steps. Furthermore, questionnaires were used to evaluate dietary intake, physical activity, perceived ability to perform physical activity, perceived support for being active, quality of life, anxiety, depression, well-being, perceived treatment, perceived stress and diabetes self- efficacy.

Discussion

This study will show if a multi-component intervention using pedometers with group- and individual consultations is more effective than a single- component intervention using pedometers alone, in increasing physical activity and improving HbA1c, other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes.

Trial registration

ClinicalTrials.gov Identifier: NCT02374788. Registered 28 January 2015.
Literature
1.
Authors/Task Force M, Ryden L, Grant PJ, Anker SD, Berne C, Cosentino F, et al. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J. 2013;34(39):3035–87.CrossRef
2.
Colberg SR, Albright AL, Blissmer BJ, Braun B, Chasan-Taber L, Fernhall B, et al. Exercise and type 2 diabetes: American College of Sports Medicine and the American Diabetes Association: joint position statement. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2010;42(12):2282–303.CrossRefPubMed
3.
Snowling NJ, Hopkins WG. Effects of different modes of exercise training on glucose control and risk factors for complications in type 2 diabetic patients: a meta-analysis. Diab Care. 2006;29(11):2518–27.CrossRef
4.
Sluik D, Buijsse B, Muckelbauer R, Kaaks R, Teucher B, Johnsen NF, et al. Physical Activity and Mortality in Individuals With Diabetes Mellitus: A Prospective Study and Meta-analysis. Arch Intern Med. 2012;172(17):1285–95.CrossRefPubMed
5.
Tuomilehto J, Schwarz P, Lindstrom J. Long-term benefits from lifestyle interventions for type 2 diabetes prevention: time to expand the efforts. Diab Care. 2011;34 Suppl 2:S210–214.CrossRef
6.
Penn L, White M, Oldroyd J, Walker M, Alberti KG, Mathers JC. Prevention of type 2 diabetes in adults with impaired glucose tolerance: the European Diabetes Prevention RCT in Newcastle upon Tyne, UK. BMC Public Health. 2009;9:342.CrossRefPubMedPubMedCentral
7.
Lindström J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemiö K, et al. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006;368(9548):1673–9.CrossRefPubMed
8.
Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diab Care. 1997;20(4):537–44.CrossRef
9.
Eriksson KF, Lindgarde F. Prevention of type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise. The 6-year Malmo feasibility study. Diabetologia. 1991;34(12):891–8.CrossRefPubMed
10.
Kodama S, Tanaka S, Heianza Y, Fujihara K, Horikawa C, Shimano H, et al. Association between physical activity and risk of all-cause mortality and cardiovascular disease in patients with diabetes: a meta-analysis. Diab Care. 2013;36(2):471–9.CrossRef
11.
Zethelius B, Gudbjornsdottir S, Eliasson B, Eeg-Olofsson K, Cederholm J, Swedish National Diabetes R. Level of physical activity associated with risk of cardiovascular diseases and mortality in patients with type-2 diabetes: report from the Swedish National Diabetes Register. Eur J Prev Cardiol. 2014;21(2):244–51.CrossRefPubMed
12.
13.
Committee PAGA. Physical Activity Guidelines Advisory Committee Report. Washington: US Department of Health and Human Services; 2008.
14.
Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, et al. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. Jama. 2011;305(17):1790–9.CrossRefPubMed
15.
Schwingshackl L, Missbach B, Dias S, Konig J, Hoffmann G. Impact of different training modalities on glycaemic control and blood lipids in patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetologia. 2014;57(9):1789–97.CrossRefPubMed
16.
Srikanthan P, Karlamangla AS. Relative muscle mass is inversely associated with insulin resistance and prediabetes. Findings from the third National Health and Nutrition Examination Survey. J Clin Endocrinol Metab. 2011;96(9):2898–903.CrossRefPubMed
17.
Healy GN, Dunstan DW, Salmon J, Cerin E, Shaw JE, Zimmet PZ, et al. Breaks in sedentary time: beneficial associations with metabolic risk. Diab Care. 2008;31(4):661–6.CrossRef
18.
Dunstan DW, Howard B, Healy GN, Owen N. Too much sitting–a health hazard. Diabetes Res Clin Pract. 2012;97(3):368–76.CrossRefPubMed
19.
Hagstromer M, Oja P, Sjostrom M. Physical activity and inactivity in an adult population assessed by accelerometry. Med Sci Sports Exerc. 2007;39(9):1502–8.CrossRefPubMed
20.
Vuori IM, Lavie CJ, Blair SN. Physical activity promotion in the health care system. Mayo Clin Proc. 2013;88(12):1446–61.CrossRefPubMed
21.
Sanchez A, Bully P, Martinez C, Grandes G. Effectiveness of physical activity promotion interventions in primary care: A review of reviews. Prev Med. 2014. Jul;76 Suppl:S56-67.
22.
Thomas DE, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2006; (3):CD002968.
23.
Nationella riktlinjer för diabetesvården 2010– Stöd för styrning och ledning. In: Nationella Riktlinjer. Stockholm: Socialstyrelsen; 2010.
24.
Nationella riktlinjer för diabetesvård- Stöd för styrning och ledning. In: Nationella Riktlinjer. Stockholm: Socialstyrelsen; 2014.
25.
Diabetesvård- Rekommendationer, bedömningar och sammanfattning. In: Nationella riktlinjer – Utvärdering. Stockholm: Socialstyrelsen; 2015.
26.
Health 2020: a European policy framework supporting action across government and society for health and well-being. In: Malta: World Health Organization Regional Office for Europe; 2012.
27.
Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, et al. Using pedometers to increase physical activity and improve health: a systematic review. Jama. 2007;298(19):2296–304.CrossRefPubMed
28.
De Greef K, Deforche B, Tudor-Locke C, De Bourdeaudhuij I. Increasing physical activity in Belgian type 2 diabetes patients: a three-arm randomized controlled trial. Int J Behav Med. 2011;18(3):188–98.CrossRefPubMed
29.
De Greef K, Deforche B, Tudor-Locke C, De Bourdeaudhuij I. A cognitive-behavioural pedometer-based group intervention on physical activity and sedentary behaviour in individuals with type 2 diabetes. Health Educ Res. 2010;25(5):724–36.CrossRefPubMedPubMedCentral
30.
Soroush A, Der Ananian C, Ainsworth BE, Belyea M, Poortvliet E, Swan PD, et al. Effects of a 6-Month Walking Study on Blood Pressure and Cardiorespiratory Fitness in U.S. and Swedish Adults: ASUKI Step Study. Asian J Sports Med. 2013;4(2):114–24.CrossRefPubMedPubMedCentral
31.
Deakin T, McShane CE, Cade JE, Williams RD. Group based training for self-management strategies in people with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005;2, CD003417.
32.
Patientutbildning vid diabetes- En systematisk litteraturöversikt. In: Stockholm: Swedish Council on Technology Assessment in Health Care; 2009.
33.
Greaves CJ, Sheppard KE, Abraham C, Hardeman W, Roden M, Evans PH, et al. Systematic review of reviews of intervention components associated with increased effectiveness in dietary and physical activity interventions. BMC Public Health. 2011;11:119.CrossRefPubMedPubMedCentral
34.
Garrett S, Elley CR, Rose SB, O'Dea D, Lawton BA, Dowell AC. Are physical activity interventions in primary care and the community cost-effective? A systematic review of the evidence. Br J Gen Pract. 2011;61(584):e125–133.CrossRefPubMedPubMedCentral
35.
FaR® Individanpassad skriftlig ordination av fysisk aktivitet. In: Östersund: Statens folkhälsoinstitut; 2011.
36.
Nationell utvärdering av recept förskriven fysisk aktivitet (FaR®). In: Östersund: Folkhälsoinstitutet; 2010.
37.
Miller WR RS. Motivational Interviewing: Preparing People to Change Addictive Behaviour. London: Guilford Press; 1991.
38.
Christie D, Channon S. The potential for motivational interviewing to improve outcomes in the management of diabetes and obesity in paediatric and adult populations: a clinical review. Diabetes Obes Metabol. 2014;16(5):381–7.CrossRef
39.
Morton K, Beauchamp M, Prothero A, Joyce L, Saunders L, Spencer-Bowdage S, et al. The effectiveness of motivational interviewing for health behaviour change in primary care settings: a systematic review. Health Psychol Rev. 2014;1–19.
40.
Tudor-Locke C, Lutes L. Why do pedometers work?: a reflection upon the factors related to successfully increasing physical activity. Sports Med. 2009;39(12):981–93.CrossRefPubMed
41.
Matthews L, Kirk A, Macmillan F, Mutrie N. Can physical activity interventions for adults with type 2 diabetes be translated into practice settings? A systematic review using the RE-AIM framework. Transl Behav Med. 2014;4(1):60–78.CrossRefPubMed
42.
Der Ananian C, Soroush A, Ainsworth B, Belyea M, Walker J, Poortvliet E, et al. Trajectories and Predictors of Steps in a Worksite Intervention: ASUKI-Step. Health Behav Policy Rev. 2015;2(1):46–61.CrossRef
43.
44.
Schwarz PE, Greaves CJ, Lindstrom J, Yates T, Davies MJ. Nonpharmacological interventions for the prevention of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012;8(6):363–73.PubMed
45.
46.
Taylor-Piliae RE, Norton LC, Haskell WL, Mahbouda MH, Fair JM, Iribarren C, et al. Validation of a new brief physical activity survey among men and women aged 60-69 years. Am J Epidemiol. 2006;164(6):598–606.CrossRefPubMed
47.
Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, et al. How many steps/day are enough? For adults. Int J Behav Nutr Phys Act. 2011;8:79.CrossRefPubMedPubMedCentral
48.
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;26(11):1479–98.CrossRefPubMed
49.
National Cancer Institute USDOHHS, National Institutes Of Health. Theory at a Glance: A Guide for Health Promotion Practice. In: Createspace; 2012.
50.
Povoa G, Roovete A, Hall K. Cross-reaction of serum somatomedin-binding protein in a radioimmunoassay developed for somatomedin-binding protein isolated from human amniotic fluid. Acta Endocrinol. 1984;107(4):563–70.PubMed
51.
Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998;30(5):777–81.CrossRefPubMed
52.
Matthew CE. Calibration of accelerometer output for adults. Med Sci Sports Exerc. 2005;37(11 Suppl):S512–522.CrossRefPubMed
53.
Matthews CE, Chen KY, Freedson PS, Buchowski MS, Beech BM, Pate RR, et al. Amount of time spent in sedentary behaviors in the United States, 2003-2004. Am J Epidemiol. 2008;167(7):875–81.CrossRefPubMedPubMedCentral
54.
Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011;3(5):472–9.CrossRefPubMed
55.
Hanna Sepp UE, Wulf Becker. Enkätfrågor om kost och fysisk aktivitet bland vuxna − Underlag till urval av frågor i befolkningsinriktade enkäter. In: Livsmedelsverket; 2004.
56.
Babor TH-BJ, Saunders JB, Monteiro MG, et al. AUDIT-The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care. 2nd ed. Geneva: World Health Organization; 2001.
57.
EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. (Amsterdam, Netherlands) 1990; 16(3):199-208.
58.
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95.CrossRefPubMed
59.
J. Sallis RG, Pinski R, Patterson T, et al. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987;1987(16):825–36.CrossRef
60.
Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport. 1992;63(1):60–6.CrossRefPubMed
61.
Mujahid MS, Diez Roux AV, Morenoff JD, Raghunathan T. Assessing the measurement properties of neighborhood scales: from psychometrics to ecometrics. Am J Epidemiol. 2007;165(8):858–67.CrossRefPubMed
62.
Lisspers J, Nygren A, Soderman E. Hospital Anxiety and Depression Scale (HAD): some psychometric data for a Swedish sample. Acta Psychiatr Scand. 1997;96(4):281–6.CrossRefPubMed
63.
Eskin M, Parr D. Introducing a Swedish version of an instrument measuring mental stress. In: Reports from the Department of Psychology, the University of Stockholm, vol. 813. Stockholm: Dept. of Psychology, Stockholm University; 1996.
64.
Amsberg S, Wredling R, Lins PE, Adamson U, Johansson UB. The psychometric properties of the Swedish version of the Problem Areas in Diabetes Scale (Swe-PAID-20): scale development. Int J Nurs Stud. 2008;45(9):1319–28.CrossRefPubMed
65.
Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, et al. Assessment of diabetes-related distress. Diab Care. 1995;18(6):754–60.CrossRef
66.
Zethelius B, Eliasson B, Eeg-Olofsson K, Svensson AM, Gudbjornsdottir S, Cederholm J. A new model for 5-year risk of cardiovascular disease in type 2 diabetes, from the Swedish National Diabetes Register (NDR). Diabetes Res Clin Pract. 2011;93(2):276–84.CrossRefPubMed
67.
Gagliardi AR, Faulkner G, Ciliska D, Hicks A. Factors contributing to the effectiveness of physical activity counselling in primary care: a realist systematic review. Patient Educ Couns. 2015;98(4):412–9.CrossRefPubMed
68.
Normansell R, Smith J, Victor C, Cook DG, Kerry S, Iliffe S, et al. 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.CrossRefPubMedPubMedCentral
69.
Haas L, Maryniuk M, Beck J, Cox CE, Duker P, Edwards L, et al. National standards for diabetes self-management education and support. Diab Care. 2014;37 Suppl 1:S144–153.CrossRef
70.
Porter M, Olmsted Teisberg E. Redefining Health Care: Creating Value-based Competition on Result. Boston. Harvard Business School Press; 2006.
Metadata
Title
Physical activity promotion in the primary care setting in pre- and type 2 diabetes - the Sophia step study, an RCT
Authors
Jenny Rossen
Agneta Yngve
Maria Hagströmer
Kerstin Brismar
Barbara E. Ainsworth
Christina Iskull
Peter Möller
Unn-Britt Johansson
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2015
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-015-1941-9

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