Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial

Jussi Pihlajamäki, Reija Männikkö, Tanja Tilles-Tirkkonen, Leila Karhunen, Marjukka Kolehmainen, Ursula Schwab, Niina Lintu, Jussi Paananen, Riia Järvenpää, Marja Harjumaa, Janne Martikainen, Johanna Kohl, Kaisa Poutanen, Miikka Ermes, Pilvikki Absetz, Jaana Lindström, Timo A Lakka, StopDia study group, Tiina Laatikainen, Kennet Harald, Markku Peltonen, Pekka Jousilahti, Katri Hemiö, Maliheh Nekouei Marvi Langari, Eeva Virtanen, Saara Pentikäinen, Johanna Leväsluoto, Adil Umer, Juha Leppänen, Samuli Heinonen, Elina M Mattila, Kari Jalkanen, Jussi Pihlajamäki, Reija Männikkö, Tanja Tilles-Tirkkonen, Leila Karhunen, Marjukka Kolehmainen, Ursula Schwab, Niina Lintu, Jussi Paananen, Riia Järvenpää, Marja Harjumaa, Janne Martikainen, Johanna Kohl, Kaisa Poutanen, Miikka Ermes, Pilvikki Absetz, Jaana Lindström, Timo A Lakka, StopDia study group, Tiina Laatikainen, Kennet Harald, Markku Peltonen, Pekka Jousilahti, Katri Hemiö, Maliheh Nekouei Marvi Langari, Eeva Virtanen, Saara Pentikäinen, Johanna Leväsluoto, Adil Umer, Juha Leppänen, Samuli Heinonen, Elina M Mattila, Kari Jalkanen

Abstract

Background: The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT.

Methods: The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70 years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC ≥12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system.

Discussion: Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care.

Trial registration: ClinicalTials.gov . Identifier: NCT03156478 . Date of registration 17.5.2017.

Keywords: Digital health behavior change intervention; Effectiveness; Lifestyle intervention; Prevention; Randomized controlled trial; Scalability; Type 2 diabetes.

Conflict of interest statement

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Flow diagram of the Stop Diabetes intervention study

References

    1. Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, et al. 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. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403.
    1. Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V. The Indian diabetes prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1) Diabetologia. 2006;49(2):289–297.
    1. Telle-Hjellset V, Kjøllesdal MKR, Bjørge B, Holmboe-Ottesen G, Wandel M, Birkeland KI, et al. The InnvaDiab-DE-PLAN study: a randomised controlled trial with a culturally adapted education programme improved the risk profile for type 2 diabetes in Pakistani immigrant women. Br J Nutr. 2013;109(3):529–538.
    1. Lindström J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinänen-Kiukaanniemi S, et al. Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish diabetes prevention study (DPS) Diabetologia. 2013;56(2):284–293.
    1. Diabetes Prevention Program Research Group Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the diabetes prevention program outcomes study. Lancet Diabetes Endocrinol. 2015;3(11):866–875.
    1. Bellamy L, Casas J-P, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009;373(9677):1773–1779.
    1. Morris DH, Khunti K, Achana F, Srinivasan B, Gray LJ, Davies MJ, et al. Progression rates from HbA1c 6.0–6.4% and other prediabetes definitions to type 2 diabetes: a meta-analysis. Diabetologia. 2013;56(7):1489–1493.
    1. Lindström J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003;26(3):725–731.
    1. Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: learnings from the last 15 years. Implement Sci. 2015;10(1):172.
    1. Howells L, Musaddaq B, McKay AJ, Majeed A. Clinical impact of lifestyle interventions for the prevention of diabetes: an overview of systematic reviews. BMJ Open. 2016;6(12):e013806.
    1. Absetz P, Valve R, Oldenburg B, Heinonen H, Nissinen A, Fogelholm M, et al. Type 2 diabetes prevention in the ‘real world’ one-year results of the GOAL implementation trial. Diabetes Care. 2007;30(10):2465–2470.
    1. Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, et al. The Effectiveness of Mobile-Health Technology-Based Health Behaviour Change or Disease Management Interventions for Health Care Consumers: A Systematic Review. Cornford T, editor. PLoS Med. 2013 ;10(1):e1001362.
    1. Kohl LF, Crutzen R, de Vries NK. Online prevention aimed at lifestyle behaviors: a systematic review of reviews. J Med Internet Res. 2013;15(7):e146.
    1. Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38–e46.
    1. Borodulin K, Levälahti E, Saarikoski L, Lund L, Juolevi A, Grönholm M, et al. Kansallinen FINRISKI 2012 -terveystutkimus Osa 2: Tutkimuksen taulukkoliite. 2013.
    1. Green BB, Anderson ML, Ralston JD, Catz S, Fishman PA, Cook AJ. Patient ability and willingness to participate in a web-based intervention to improve hypertension control. J Med Internet Res. 2011;13(1):e1.
    1. Bender AM, Jørgensen T, Helbech B, Linneberg A, Pisinger C. Socioeconomic position and participation in baseline and follow-up visits: the Inter99 study. Eur J Prev Cardiol. 2014;21(7):899–905.
    1. The National Nutrition Council of Finland. Terveyttä ruoasta - Suomalaiset ravitsemussuositukset 2014. 2014.
    1. Nordic Council of Ministers. Nordic Nutrition Recommendations 2012 - Integrating nutrition and physical activity. Copenhagen, Denmark, 2012.
    1. Haskell WL, Lee I-M, Pate RR, Powell KE, Blair SN, Franklin BA, et al. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007;116(9):1081–1093.
    1. Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, et al. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010;33(12):e147–e167.
    1. Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee I-M, et al. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011;43(7):1334–1359.
    1. Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000;55(1):68–78.
    1. Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95.
    1. Mann T, de Ridder D, Fujita K. Self-regulation of health behavior: social psychological approaches to goal setting and goal striving. Health Psychol. 2013;32(5):487–498.
    1. Satter E. Eating competence: nutrition education with the Satter eating competence model. J Nutr Educ Behav. 2007;39(5):S189–S194.
    1. Wood W, Rünger D. Psychology of habit. Annu Rev Psychol. 2016;67(1):289–314.
    1. Lally P, Gardner B. Promoting habit formation. Health Psychol Rev. 2013;7(sup1):S137–S158.
    1. Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, et al. Recommended amount of sleep for a healthy adult: a joint consensus statement of the American Academy of sleep medicine and Sleep Research Society. Sleep. 2015;38(6):843–844.
    1. Pan A, Wang Y, Talaei M, Hu FB, Wu T. Relation of active, passive, and quitting smoking with incident type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015;3(12):958–967.
    1. Holst C, Becker U, Jørgensen ME, Grønbæk M, Tolstrup JS. Alcohol drinking patterns and risk of diabetes: a cohort study of 70,551 men and women from the general Danish population. Diabetologia. 2017;60(10):1941–1950.
    1. Fisher EB, Chan JCN, Kowitt S, Nan H, Sartorius N, Oldenburg B. Conceptual Perspectives on the Co-Occurrence of Mental and Physical Disease: Diabetes and Depression as a Model. Basel: Karger Publishers; 2014. p. 1–14.
    1. Absetz P, Oldenburg B, Hankonen N, Valve R, Heinonen H, Nissinen A, et al. Type 2 diabetes prevention in the real world: three-year results of the GOAL lifestyle implementation trial. Diabetes Care. 2009;32(8):1418–1420.
    1. Sathish T, Williams ED, Pasricha N, Absetz P, Lorgelly P, Wolfe R, et al. Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program. BMC Public Health. 2013;13(1):1035.
    1. Hemiö K, Pölönen A, Ahonen K, Kosola M, Viitasalo K, Lindström J. A simple tool for diet evaluation in primary health care: validation of a 16-item food intake questionnaire. Int J Environ Res Public Health. 2014;11(3):2683–2697.
    1. Lohse B, Satter E, Horacek T, Gebreselassie T, Oakland MJ. Measuring eating competence: psychometric properties and validity of the ecSatter inventory. J Nutr Educ Behav. 2007;39(5):S154–S166.
    1. Karlsson J, Persson LO, Sjöström L, Sullivan M. Psychometric properties and factor structure of the three-factor eating questionnaire (TFEQ) in obese men and women. Results from the Swedish obese subjects (SOS) study. Int J Obes Relat Metab Disord. 2000;24(12):1715–1725.
    1. Borodulin K, Laatikainen T, Lahti-Koski M, Jousilahti P, Lakka TA. Association of age and education with different types of leisure-time physical activity among 4437 Finnish adults. J Phys Act Health. 2008;5(2):242–251.
    1. Borodulin K, Kärki A, Laatikainen T, Peltonen M, Luoto R. Daily sedentary time and risk of cardiovascular disease: the national FINRISK 2002 study. J Phys Act Health. 2015;12(7):904–908.
    1. Lakka TA, Salonen JT. Intra-person variability of various physical activity assessments in the Kuopio Ischaemic heart disease risk factor study. Int J Epidemiol. 1992;21(3):467–472.
    1. Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sport Exerc. 2003;35(8):1381–1395.
    1. Partinen G. Basic Nordic sleep questionnaire (BNSQ): a quantitated measure of subjective sleep complaints. J Sleep Res. 1995;4(S1):150–155.
    1. Borodulin K, Saarikoski L, Lund L, Juolevi A, Grönholm M, Helldán A, et al. Kansallinen FINRISKI 2012 -terveystutkimus Osa I: Tutkimuksen toteutus ja menetelmät Kansallinen FINRISKI 2012 -terveystutkimus. 2013.
    1. Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ. Validating the theoretical structure of the treatment self-regulation questionnaire (TSRQ) across three different health behaviors. Health Educ Res. 2006;22(5):691–702.
    1. Schwarzer R, Renner B. Social-cognitive predictors of health behavior: action self-efficacy and coping self-efficacy. Health Psychol. 2000;19(5):487–495.
    1. Tangney JP, Baumeister RF, Boone AL. High self-control predicts good adjustment, less pathology, better grades, and interpersonal success. J Pers. 2004;72(2):271–324.
    1. Sniehotta FF, Schwarzer R, Scholz U, Schüz B. Action planning and coping planning for long-term lifestyle change: theory and assessment. Eur J Soc Psychol. 2005;35(4):565–576.
    1. Gardner B, Abraham C, Lally P, de Bruijn G-J. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the self-report habit index. Int J Behav Nutr Phys Act. 2012;9(1):102.
    1. Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med (Baltim) 1987;16(6):825–836.
    1. Crockett RA, Weinman J, Hankins M, Marteau T. Time orientation and health-related behaviour: measurement in general population samples. Psychol Health. 2009;24(3):333–350.
    1. Development of the World Health Organization WHOQOL-BREF quality of life assessment The WHOQOL group. Psychol Med. 1998;28(3):551–558.
    1. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–365.
    1. Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, et al. The Warwick-Edinburgh mental well-being scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007;5(1):63.
    1. Cantril H. The pattern of human concerns. New Brunswick, NJ: Rutgers University Press; 1965.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385–396.
    1. Losoi H, Turunen S, Wäljas M, Helminen M, Öhman J, Julkunen J, et al. Psychometric properties of the Finnish version of the resilience scale and its short version. Psychol Community Heal. 2013;2(1):1–10.
    1. Russell D, Peplau LA, Cutrona CE. The revised UCLA loneliness scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980;39(3):472–480.
    1. Junttila N, Ahlqvist-björkroth S, Aromaa M, Rautava P, Piha J, Marja V, et al. Mothers and Fathers Loneliness During Pregnancy , Infancy , and Toddlerhood. Psychol Educ - An Interdiscip J 2013;50:98–104.
    1. Kivipelto M, Ngandu T, Laatikainen T, Winblad B, Soininen H, Tuomilehto J. Risk score for the prediction of dementia risk in 20 years among middle aged people: a longitudinal, population-based study. Lancet Neurol. 2006;5(9):735–741.
    1. Stancáková A, Javorský M, Kuulasmaa T, Haffner SM, Kuusisto J, Laakso M. Changes in insulin sensitivity and insulin release in relation to glycemia and glucose tolerance in 6,414 Finnish men. Diabetes. 2009;58(5):1212–1221.
    1. de Mello VDF, Lindström J, Eriksson J, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Sundvall J, et al. Insulin secretion and its determinants in the progression of impaired glucose tolerance to type 2 diabetes in impaired glucose-tolerant individuals: the Finnish diabetes prevention study. Diabetes Care. 2012;35(2):211–217.
    1. de Mello VDF, Lindström J, Eriksson JG, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Pihlajamäki J, et al. Markers of cholesterol metabolism as biomarkers in predicting diabetes in the Finnish diabetes prevention study. Nutr Metab Cardiovasc Dis. 2015;25(7):635–642.
    1. Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17(1):88.
    1. Wood W, Neal DT. Healthy through habit: interventions for initiating and maintaining health behavior change. Behav Sci Policy. 2016;2(1):71–83.

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