Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes)

Emma G Wilmot, Melanie J Davies, Charlotte L Edwardson, Trish Gorely, Kamlesh Khunti, Myra Nimmo, Thomas Yates, Stuart J H Biddle, Emma G Wilmot, Melanie J Davies, Charlotte L Edwardson, Trish Gorely, Kamlesh Khunti, Myra Nimmo, Thomas Yates, Stuart J H Biddle

Abstract

Background: The rising prevalence of Type 2 Diabetes Mellitus (T2DM) is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time) has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes) is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM.

Methods/design: A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a) aged 18-40 years with a BMI in the obese range; b) 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89) or control (n = 89) arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count < 100/min). Secondary outcomes include physical activity, sitting/lying time using the ActivPAL posture monitor, fasting and 2 h oral glucose tolerance test, lipids, inflammatory biomarkers, body weight, waist circumference, blood pressure, illness perceptions, and efficacy beliefs for behaviour change.

Conclusions: This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population.

Trial registration: Current controlled trials ISRCTN08434554, MRC project 91409.

Figures

Figure 1
Figure 1
RCT Flow Chart. a) Age 18-40 years with a BMI in the obese range (≥ 30 kg/m2; ≥ 27.5 kg/m2 for South Asians). b) Age 18-40 years with a BMI in the overweight range (≥ 25 kg/m2; ≥ 23 kg/m2 for South Asians) and with one or more additional risk factor for diabetes from: • family history of diabetes or cardiovascular disease in a first degree relative; • previous gestational diabetes; • polycystic ovarian syndrome; • HbA1c ≥ 5.8% (from our local Addition Leicester diabetes screening data a cut off HbA1c of 5.8% provided the best sensitivity and specificity for a diagnosis of prediabetes). • Impaired glucose regulation (defined according to the World Health Organisation).

References

    1. Hsia Y, Neubert AC, Rani F. et increase in the prevalence of type 1 and 2 diabetes in children and adolescents: results from prescription data from a UK general practice database. Br J Clin Pharmacol. 2009;67(2):242–249.
    1. Haines L, Wan KC, Lynn R, Barrett TG, Shield JP. Rising incidence of type 2 diabetes in children in the UK. Diab Care. 2007;30(5):1097–101.
    1. Feltbower RG, McKinney PA, Campbell FM, Stephenson CR, Bodansky HJ. Type 2 and other forms of diabetes in 0-30 year olds: a hospital based study in Leeds, UK. Arch Disease Child. 2003;88:676–679.
    1. Millett C, Khunti K, Gray J, Saxena S, Netuveli G, Majeed A. Obesity and intermediate clinical outcomes in diabetes: evidence of a differential relationship across ethnic groups. Diab Med. 2008;25:685–691.
    1. McGavock J, Sellers E, Dean H. Physical activity for the prevention and management of youth-onset type 2 diabetes mellitus: focus on cardiovascular complications. Diab Vasc Dis Res. 2007;4(4):305–310.
    1. Hillier TA, Pedula KL. Complications in young adults with early-onset Type 2 diabetes. Diab Care. 2003;26:2999–3005.
    1. Owen N, Healy GN, Matthews CE, Dunstan DW. Too much sitting: the population health science of sedentary behavior. Exer Sport Sci Rev. 2010;38(3):105–113.
    1. Pate RR, O'Neill JR, Lobelo F. The evolving definition of "sedentary". Exer Sport Sci Rev. 2008;36(4):173–178.
    1. Healy GN, Matthews CE, Dunstan DW, Winkler EAH, Owen N. Sedentary time and cardio-metabolic biomarkers in US adults: NHANES 2003-06. Eur Heart J. 2011;32(5):590–597.
    1. Morris JN, Heady JA, Raffle PA, Roberts CG, Parks JW. Coronary heart-disease and physical activity of work. Lancet. 1953;265(6796):1111.
    1. Hamilton MT, Hamilton DG, Zderic TW. Role of low energy expenditure and sitting in obesity, metabolic syndrome, Type 2 diabetes, and cardiovascular disease. Diabetes. 2007;56:2655–2667.
    1. Dunstan DW, Barr ELM, Healy GN, Salmon J, Shaw JE, Balkau B, Magliano DJ, Cameron AJ, Zimmet PZ, Owen N. Television viewing time and mortality: the Australian Diabetes, Obesity and Lifestyle Study (AusDiab) Circulation. 2010;121:384–391.
    1. Dunstan DW, Salmon J, Owen N, Armstrong T, Zimmet PZ, Welborn TA, Cameron AJ, Dwyer T, Jolley D, Shaw JE. Physical activity and television viewing in relation to risk of undiagnosed abnormal glucose metabolism in adults. Diab Care. 2004;27:2603–2609.
    1. Katzmarzyk PT, Church TS, Craig CL, Bouchard C. Sitting time and mortality from all causes, cardiovascular disease, and cancer. Med Sci Sport Exer. 2009;41(5):998–1005.
    1. Davies MJ, Heller S, Skinner TC, Campbell MJ, Carey ME, Cradock S. et al.Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ. 2008;336(7642):491–495.
    1. Yates T, Davies MJ, Gorely T, Bull F, Khunti. Rationale, design and baseline data from the prepare (prediabetes risk education and physical activity recommendation and encouragement) programme study: a randomized controlled trial. Pat Ed Couns. 2008;73:264–271.
    1. National Institute for Clinical Excellence. Guidance on the use of patient-education models for diabetes (Technology Appraisal Guidance 60) London: Author; 2003.
    1. Lawton J, Rankin D. How do structured education programmes work? An ethnographic investigation of the dose adjustment for normal eating (DAFNE) programme for type 1 diabetes patients in the UK. Soc Sci Med. 2010;71(3):486–493.
    1. Bartholomew LK, Parcel GS, Kok G, Gottlieb NH. Planning health promotion programs: An intervention mapping approach. 2. San Francisco, CA: John Wiley; 2006.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new medical research council guidance. BMJ. 2008;337:a1655.
    1. Leventhal H, Meyer D, Nerenz D. In: Contributions to Medical Psychology. Rachman S, editor. New York: Pergamon; 1980. The common-sense representation of illness danger; pp. 7–30.
    1. Bandura A. Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice Hall; 1986.
    1. Yates T, Davies M, Gorely T, Bull F, Khunti K. Effectiveness of a pragmatic education program designed to promote walking activity in individuals with impaired glucose tolerance. Diab Care. 2009;32(8):1404–1410.
    1. Gollwitzer PM. Implementation intentions: strong effects of simple plans: how can good intentions become effective behavior change strategies? Am Psychol. 1999;54:493–503.
    1. Epstein LH, Roemmich JN. Reducing sedentary behaviour: role in modifying physical activity. Exer Sport Sci Rev. 2001;29(3):103–108.
    1. Skinner T, Davies M, Heller S, Khunti K. To determine the effects of a structured educational programme on illness beliefs, quality of life and physical activity in individuals with newly diagnosed type 2 diabetes: results from the DESMOND (Diabetes education and self-management for ongoing and newly diagnosed) pilot study. Diab Med. 2005;22(Suppl 2):15.
    1. Healy GN, Wijndaele K, Dunstan DW, Shaw JE, Salmon J, Zimmet PZ. et al.Objectively measured sedentary time, physical activity, and metabolic risk: the Australian Diabetes, Obesity and Lifestyle Study (AusDiab) Diab Care. 2008;31:369–371.
    1. Plasqui G, Westerterp KR. Physical activity assessment with accelerometers: an evaluation against doubly labeled water. Obesity. 2007;15:2371–2379.
    1. Healy GN, Clark BK, Winkler EAH, Gardiner PA, Brown WJ, Matthews CE. Measurement of adults' sedentary time in population-based studies. Am J Prev Med. 2011;41(2):216–227.
    1. Matthews CE, Chen KY, Freedson PS, Buchowski MS, Beech BM, Pate RR, Troiano RP. Amount of time spent in sedentary behaviors in the United States, 2003-2004. Am J Epid. 2008;167:875–881.
    1. Rosenberg DE, Bull FC, Marshall AL, Sallis JF, Bauman AE. Assessment of sedentary behavior with the international physical activity questionnaire. J Phys Act Health. 2008;5(Suppl 1):S30–S44.
    1. Freedson PS, Melanson E, Sirard J. Calibration of the computer science and applications, inc. accelerometer. Med Sci Sports Exerc. 1998;30:777–781.
    1. Grant PM, Ryan CG, Tigbe WW, Granat MH. The validation of a novel activity monitor in the measurement of posture and motion during everyday activities. Br J Sports Med. 2006;40(12):992–997.
    1. Kozey-Keadle S, Libertine A, Lyden K, Staudenmayer J, Freedson P. Validation of wearable monitors for assessing sedentary behavior. Med Sci Sports Exerc. 2011;43(8):1561–1567.
    1. Hart TL, Ainsworth BE, Tudor-Locke C. Objective and subjective measures of sedentary behavior and physical activity. Med Sci Sports Exerc. 2011;43(3):449–456.
    1. 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;35(8):1381–1395.
    1. Friedewald W, Levy R, Fredrickson D. Estimation of the concentration of low density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972;18:499–502.
    1. Kind P, Dolan P, Gudex C, Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ. 1998;316:736–741.
    1. Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006;60:631–637.
    1. Keller C, Fleury J, Gregor-Holt N, Thompson T. Predictive ability of social cognitive theory in exercise research: an integrated literature review. Online J Know Synth Nursing. 1999;6:2.
    1. Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D. et al.Development of a fatigue scale. J Psychosom Res. 1993;37(2):147–153.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiat Res. 1989;28(2):193–213.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 2006;67:361–370.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner