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BMC Psychiatry
Published in: BMC Psychiatry 1/2017

Open Access 01-12-2017 | Study protocol

Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a multidimensional web tool intervention to improve cardiometabolic health in patients with severe mental illness

Authors: Anne Looijmans, Frederike Jörg, Richard Bruggeman, Robert Schoevers, Eva Corpeleijn

Published in: BMC Psychiatry | Issue 1/2017

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Abstract

Background

The cardiometabolic health of persons with a severe mental illness (SMI) is alarming with obesity rates of 45-55% and diabetes type 2 rates of 10-15%. Unhealthy lifestyle behaviours play a large role in this. Despite the multidisciplinary guideline for SMI patients recommending to monitor and address patients’ lifestyle, most mental health care professionals have limited lifestyle-related knowledge and skills, and (lifestyle) treatment protocols are lacking. Evidence-based practical lifestyle tools may support both patients and staff in improving patients’ lifestyle. This paper describes the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial, to investigate whether a multidimensional lifestyle intervention using a web tool can be effective in improving cardiometabolic health in SMI patients.

Methods/Design

The LION study is a 12-month pragmatic single-blind multi-site cluster randomised controlled trial. 21 Flexible Assertive Community Treatment (ACT) teams and eight sheltered living teams of five mental health organizations in the Netherlands are invited to participate. Per team, nurses are trained in motivational interviewing and use of the multidimensional web tool, covering lifestyle behaviour awareness, lifestyle knowledge, motivation and goal setting. Nurses coach patients to change their lifestyle using the web tool, motivational interviewing and stages-of-change techniques during biweekly sessions in a) assessing current lifestyle behaviour using the traffic light method (healthy behaviours colour green, unhealthy behaviours colour red), b) creating a lifestyle plan with maximum three attainable lifestyle goals and c) discussing the lifestyle plan regularly. The study population is SMI patients and statistical inference is on patient level using multilevel analyses. Primary outcome is waist circumference and other cardiometabolic risk factors after six and twelve months intervention, which are measured as part of routine outcome monitoring using standard protocols. Secondary outcomes include depressive and negative symptoms, cost-effectiveness, and barriers and facilitators in intervention implementation.

Discussion

Adequate health care should target both mental health and lifestyle behaviours in SMI patients. This trial contributes by studying a 12-month multidimensional lifestyle intervention as a potential evidence based (nursing) tool for targeting multiple lifestyle behaviours in SMI patients.

Trial registration

Nederlands Trialregister NTR3765 (trialregister.nl; registered 21 December 2012).
Literature
1.
HERT M, Correll CU, Bobes J, et al. Physical illness in patients with severe mental disorders. I. prevalence, impact of medications and disparities in health care. World Psychiatry. 2011;10(1):52–77.CrossRef
2.
Vancampfort D, De Hert M, Stubbs B, et al. Negative symptoms are associated with lower autonomous motivation towards physical activity in people with schizophrenia. Compr Psychiatry. 2015;56:128–32.CrossRefPubMed
3.
Vancampfort D, Knapen J, Probst M, Scheewe T, Remans S, De Hert M. A systematic review of correlates of physical activity in patients with schizophrenia. Acta Psychiatr Scand. 2012;125(5):352–62.CrossRefPubMed
4.
Gierisch JM, Nieuwsma JA, Bradford DW, et al. Pharmacologic and behavioral interventions to improve cardiovascular risk factors in adults with serious mental illness: A systematic review and meta-analysis. J Clin Psychiatry. 2014;75(5):424–40.CrossRef
5.
Lambert TJ, Newcomer JW. Are the cardiometabolic complications of schizophrenia still neglected? barriers to care. Med J Aust. 2009;190(4):S39.PubMed
6.
Meeuwissen J, van Gool R, Hermens M, van Meijel B. Leefstijlbevordering bij mensen met een ernstige psychische aandoening. Nederlands Tijdschrift voor Evid Based Pract. 2015;13(4):7–10.CrossRef
7.
Bruins, J., Pijnenborg, G. M. H., van den Heuvel, E. R., Visser, E., Corpeleijn, E., Bartels-Velthuis, A. A., Bruggeman, R., & Jörg, F. Persistent low treatment rates of metabolic risk factors in people with psychotic disorders. A PHAMOUS study. Accepted for publication in Journal of Clinical Psychiatry on August 12th 2016.
8.
McGinty EE, Baller J, Azrin ST, Juliano-Bult D, Daumit GL. Interventions to address medical conditions and health-risk behaviors among persons with serious mental illness: a comprehensive review. Schizophr Bull. 2016;42(1):96–124.PubMed
9.
Bruins J, Jörg F, Bruggeman R, Slooff C, Corpeleijn E, Pijnenborg M. The effects of lifestyle interventions on (long-term) weight management, cardiometabolic risk and depressive symptoms in people with psychotic disorders: A meta-analysis. PloS One. 2014;9(12):e112276.CrossRefPubMedPubMedCentral
10.
Cabassa L, Ezell J, Lewis-FernĂĄndez R. Lifestyle interventions for adults with serious mental illness: a systematic literature review. Psychiatr Serv. 2010;61(8):774–82.CrossRefPubMedPubMedCentral
11.
Faulkner G, Cohn T, Remington G. Interventions to reduce weight gain in schizophrenia. The Cochrane Library. 2007;33(3):654–56.
12.
Daumit GL, Dickerson FB, Wang N, et al. A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med. 2013;368(17):1594–602.CrossRefPubMedPubMedCentral
13.
Klesges LM, Estabrooks PA, Dzewaltowski DA, Bull SS, Glasgow RE. Beginning with the application in mind: designing and planning health behavior change interventions to enhance dissemination. Ann Behav Med. 2005;29(2):66–75.CrossRefPubMed
14.
Lorig KR, Holman HR. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1–7.CrossRefPubMed
15.
Searight R. Realistic approaches to counseling in the office setting. Am Fam Physician. 2009;79(4):277–84.PubMed
16.
Miller WR, Rollnick S. Motivational interviewing: Preparing people to change. New York: Guilford Press; 2002.
17.
Prochaska JO, DiClemente CC. Transtheoretical therapy: Toward a more integrative model of change. Psychother Theory, Res Pract. 1982;19(3):276.CrossRef
18.
Britt E, Hudson SM, Blampied NM. Motivational interviewing in health settings: a review. Patient Educ Couns. 2004;53(2):147–55.CrossRefPubMed
19.
Armstrong M, Mottershead T, Ronksley P, Sigal R, Campbell T, Hemmelgarn B. Motivational interviewing to improve weight loss in overweight and/or obese patients: a systematic review and meta‐analysis of randomized controlled trials. Obes Rev. 2011;12(9):709–23.PubMed
20.
Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: A systematic review and meta-analysis. Br J Gen Pract. 2005;55(513):305–12.PubMedPubMedCentral
21.
Arkowitz H, Miller WR. Learning, applying, and extending motivational interviewing. In Arkowitz H, Westra HA, Miller WR, & Rollnick S (Eds.), Motivational interviewing in the treatment of psychological problems. Motivat Interv Treatment Psycholl Prob. New York: Guilford; 2008. pp. 1-25.
22.
Glanz K, Rimer BK, Viswanath K. Health behavior and health education: Theory, research, and practice. San Francisco: Wiley; 2008.
23.
Bradshaw T, Wearden A, Marshall M, et al. Developing a healthy living intervention for people with early psychosis using the medical research council's guidelines on complex interventions: Phase 1 of the HELPER–InterACT programme. Int J Nurs Stud. 2012;49(4):398–406.CrossRefPubMed
24.
Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009;10(37):9.
25.
Meijel B, Hamersveld S, Gool R, der Bijl J, Harten P. Effects and feasibility of the “Traffic light method for somatic screening and lifestyle” in patients with severe mental illness: A pilot study. Perspect Psychiatr Care. 2015;51(2):106–13.CrossRefPubMed
26.
Richardson CR, Faulkner G, McDevitt J, Skrinar GS, Hutchinson DS, Piette JD. Integrating physical activity into mental health services for persons with serious mental illness. Psychiatr Serv. 2005;56(3):324–31.CrossRefPubMed
27.
Ströhle A. Physical activity, exercise, depression and anxiety disorders. J Neural Transm. 2009;116(6):777–84.CrossRefPubMed
28.
Gorczynski P, Faulkner G. Exercise therapy for schizophrenia. TSchizophr Bull. 2010;36:665–66.CrossRef
29.
Chan A, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefPubMedPubMedCentral
30.
31.
Blankers M, van Emmerik A, Richters B, Dekker J. Blended internet care for patients with severe mental illnesses: An open label prospective controlled cohort pilot study. Internet Interventions. 2016;5:51–5.CrossRef
32.
Han TS, Richmond P, Avenell A, Lean ME. Waist circumference reduction and cardiovascular benefits during weight loss in women. Int J Obes Relat Metab Disord. 1997;21(2):127–34.CrossRefPubMed
33.
Prochaska JO, DiClemente CC. The transtheoretical approach. Handbook Psychother Integr. 2005;2:147–71.CrossRef
34.
Bruins J, Pijnenborg MG, Bartels-Velthuis AA, et al. Cannabis use in people with severe mental illness: The association with physical and mental health - a cohort study. A pharmacotherapy monitoring and outcome survey study. J Psychopharmacol. 2016;30(4):354–62.CrossRefPubMed
35.
Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261–76.CrossRefPubMed
36.
Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: The calgary depression scale. British J Psychiat. 1993;163(22);39S-44S.
37.
Priebe S, Huxley P, Knight S, Evans S. Application and results of the manchester short assessment of quality of life (MANSA). Int J Soc Psychiatr. 1999;45(1):7–12.CrossRef
38.
Wing JK, Curtis R, Beevor A. HoNOS: Health of the nation outcome scales: Report on research and development july 1993-december 1995. London: Royal College of Psychiatrists; 1996.
39.
Wendel-Vos GCW, Schuit AJ, Saris WHM, Kromhout D. Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003;56(12):1163–9.CrossRefPubMed
40.
Health Council of the Netherlands. Guidelines for a healthy diet 2006. The Hague: Health Council of the Netherlands; 2006. publication no. 2006/21.
41.
Hakkaart-van Roijen L. Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P). Rotterdam: Institute for Medical Technology Assessment; 2002.
42.
McCrone P, Patel A, Knapp M, et al. A comparison of SF-6D and EQ-5D utility scores in a study of patients with schizophrenia. J Ment Health Policy Econ. 2009;12(1):27–31.PubMed
43.
Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Med Care. 2004;42(9):851–9.CrossRefPubMed
44.
Schneider PL, Crouter SE, Bassett DR. Pedometer measures of free-living physical activity: Comparison of 13 models. Med Sci Sports Exerc. 2004;36(2):331–5.CrossRefPubMed
45.
Rush EC, Crowley J, Freitas IF, Luke A. Validity of Hand‐to‐Foot measurement of bioimpedance: Standing compared with lying position. Obesity. 2006;14(2):252–7.CrossRefPubMed
46.
Sun SS, Chumlea WC, Heymsfield SB, et al. Development of bioelectrical impedance analysis prediction equations for body composition with the use of a multicomponent model for use in epidemiologic surveys. Am J Clin Nutr. 2003;77(2):331–40.PubMed
47.
Kyle UG, Bosaeus I, De Lorenzo AD, et al. Bioelectrical impedance analysis--part I: Review of principles and methods. Clin Nutr. 2004;23(5):1226–43.CrossRefPubMed
48.
Kemper H, Ooijendijk W, Stiggelbout M. Consensus over de nederlandse norm voor gezond bewegen. TSG: Tijdschrift voor gezondheidswetenschappen. 2000;3(78):180–3.
49.
Walters ME, Dijkstra A, de Winter AF, Reijneveld SA. Development of a training programme for home health care workers to promote preventive activities focused on a healthy lifestyle: An intervention mapping approach. BMC Health Serv Res. 2015;15(1):1.CrossRef
50.
de Vries H, Dijkstra M, Kuhlman P. Self-efficacy: the third factor besides attitude and subjective norm as a predictor of behavioural intentions. Health Educ Res. 1988;3(3):273–82.CrossRef
51.
De Vries H, Backbier E, Kok G, Dijkstra M. Measuring the impact of social influences on smoking onset in a longitudinal study: An integration of social psychological approaches. J Appl Soc Psychol. 1995;25:237–57.CrossRef
52.
Dobbelsteyn C, Joffres M, MacLean DR, Flowerdew G. A comparative evaluation of waist circumference, waist-to-hip ratio and body mass index as indicators of cardiovascular risk factors. the canadian heart health surveys. Int J Obes. 2001;25(5):652.CrossRef
53.
Janssen I, Katzmarzyk PT, Ross R. Waist circumference and not body mass index explains obesity-related health risk. Am J Clin Nutr. 2004;79(3):379–84.PubMed
54.
55.
Zygmunt A, Olfson M, Boyer CA, Mechanic D. Interventions to improve medication adherence in schizophrenia. Am J Psychiatry. 2002;159(10):1653–64.CrossRefPubMed
56.
57.
Gagne C, White W, Anthony WA. Recovery: A common vision for the fields of mental health and addictions. Psychiatr Rehabil J. 2007;31(1):32.CrossRefPubMed
58.
Doran GT. There’sa SMART way to write management’s goals and objectives. Manage Rev. 1981;70(11):35–6.
Metadata
Title
Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a multidimensional web tool intervention to improve cardiometabolic health in patients with severe mental illness
Authors
Anne Looijmans
Frederike Jörg
Richard Bruggeman
Robert Schoevers
Eva Corpeleijn
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2017
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-017-1265-7

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