Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial

Nick Verhaeghe, Jan De Maeseneer, Lea Maes, Cornelis Van Heeringen, Veerle Bogaert, Els Clays, Dirk De Bacquer, Lieven Annemans, Nick Verhaeghe, Jan De Maeseneer, Lea Maes, Cornelis Van Heeringen, Veerle Bogaert, Els Clays, Dirk De Bacquer, Lieven Annemans

Abstract

Background: Growing attention is given to the effects of health promotion programs targeting physical activity and healthy eating in individuals with mental disorders. The design of evaluation studies of public health interventions poses several problems and the current literature appears to provide only limited evidence on the effectiveness of such programs. The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders living in sheltered housing. In this paper, the design of the study and baseline findings are described.

Methods/design: The design consists of a cluster preference randomized controlled trial. All sheltered housing organisations in the Flanders region (Belgium) were asked if they were interested to participate in the study and if they were having a preference to serve as intervention or control group. Those without a preference were randomly assigned to the intervention or control group. Individuals in the intervention group receive a 10-week health promotion intervention above their treatment as usual. Outcome assessments occur at baseline, at 10 and at 36 weeks. The primary outcomes include body weight, Body Mass Index, waist circumference, and fat mass. Secondary outcomes consist of physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity. Cost-effectiveness of the intervention will be examined by calculating the Cost-Effectiveness ratio and through economic modeling.Twenty-five sheltered housing organisations agreed to participate. On the individual level 324 patients were willing to participate, including 225 individuals in the intervention group and 99 individuals in the control group. At baseline, no statistical significant differences between the two groups were found for the primary outcome variables.

Discussion: This is the first trial evaluating both the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in mental health care using a cluster preference randomized controlled design. The baseline characteristics already demonstrate the unhealthy condition of the study population.

Trial registration: This study is registered at clinicaltrials.gov - NCT 01336946.

Trial registration: ClinicalTrials.gov NCT01336946.

Figures

Figure 1
Figure 1
Health promotion intervention: Study design.
Figure 2
Figure 2
Theoretical framework of the health promotion intervention targeting physical activity and healthy eating.
Figure 3
Figure 3
Health promotion intervention: Recruitment process.

References

    1. Filik R, Sipos A, Kehoe PG, Burns T, Cooper SJ, Stevens H. et al.The cardiovascular and respiratory health of people with schizophrenia. Acta Psychiatr Scand. 2006;113:298–305. doi: 10.1111/j.1600-0447.2006.00768.x.
    1. Limosin F, Gasquet I, Leguay D, Azorin JM, Rouillon F. Body mass index and prevalence of obesity in a French cohort of patients with schizophrenia. Acta Psychiatr Scand. 2008;118:19–25. doi: 10.1111/j.1600-0447.2008.01208.x.
    1. Parsons B, Allison DB, Loebel A, Williams K, Giller E, Romano S. et al.Weight effects associated with antipsychotics: a comprehensive database analysis. Schizophr Res. 2009;110:103–110. doi: 10.1016/j.schres.2008.09.025.
    1. Brown S, Birtwistle J, Roe L, Thompson C. The unhealthy lifestyle of people with schizophrenia. Psychol Med. 1999;29:697–701. doi: 10.1017/S0033291798008186.
    1. Osborn DP, Nazareth I, King MB. Physical activity, dietary habits and Coronary Heart Disease risk factor knowledge amongst people with severe mental illness: a cross sectional comparative study in primary care. Soc Psychiatry Psychiatr Epidemiol. 2007;42:787–793. doi: 10.1007/s00127-007-0247-3.
    1. Roick C, Fritz-Wieacker A, Matschinger H, Heider D, Schindler J, Riedel-Heller S. et al.Health habits of patients with schizophrenia. Soc Psychiatry Psychiatr Epidemiol. 2007;42:268–276. doi: 10.1007/s00127-007-0164-5.
    1. Strassnig M, Brar JS, Ganguli R. Nutritional assessment of patients with schizophrenia: a preliminary study. Schizophr Bull. 2003;29:393–397. doi: 10.1093/oxfordjournals.schbul.a007013.
    1. De Hert M, Dekker JM, Wood D, Kahl KG, Holt RI, Moller HJ. Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC) Eur Psychiatry. 2009;24:412–424. doi: 10.1016/j.eurpsy.2009.01.005.
    1. Lowe T, Lubos E. Effectiveness of weight management interventions for people with serious mental illness who receive treatment with atypical antipsychotic medications. A literature review. J Psychiatr Ment Health Nurs. 2008;15:857–863. doi: 10.1111/j.1365-2850.2008.01337.x.
    1. Muller-Riemenschneider F, Reinhold T, Willich SN. Cost-effectiveness of interventions promoting physical activity. Br J Sports Med. 2009;43:70–76.
    1. Roux L, Pratt M, Tengs TO, Yore MM, Yanagawa TL, Van Den Bos J. et al.Cost effectiveness of community-based physical activity interventions. Am J Prev Med. 2008;35:578–588. doi: 10.1016/j.amepre.2008.06.040.
    1. Verhaeghe N, De MJ, Maes L, Van HC, Annemans L. Effectiveness and cost-effectiveness of lifestyle interventions on physical activity and eating habits in persons with severe mental disorders: a systematic review. Int J Behav Nutr Phys Act. 2011;8:28. doi: 10.1186/1479-5868-8-28.
    1. Rychetnik L, Frommer M, Hawe P, Shiell A. Criteria for evaluating evidence on public health interventions. J Epidemiol Community Health. 2002;56:119–127. doi: 10.1136/jech.56.2.119.
    1. Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ. 2003;327:785–789. doi: 10.1136/bmj.327.7418.785.
    1. Christie J, O’Halloran P, Stevenson M. Planning a cluster randomized controlled trial: methodological issues. Nurs Res. 2009;58:128–134. doi: 10.1097/NNR.0b013e3181900cb5.
    1. Medical Research Council. Cluster randomized trials: methodological and ethical considerations. Medical Research Council, London; 2002.
    1. Howard L, Thornicroft G. Patient preference randomised controlled trials in mental health research. Br J Psychiatry. 2006;188:303–304. doi: 10.1192/bjp.188.4.303.
    1. Macias C, Gold PB, Hargreaves WA, Aronson E, Bickman L, Barreira PJ. et al.Preference in random assignment: implications for the interpretation of randomized trials. Adm Policy Ment Health. 2009;36:331–342. doi: 10.1007/s10488-009-0224-0.
    1. TenHave TR, Coyne J, Salzer M, Katz I. Research to improve the quality of care for depression: alternatives to the simple randomized clinical trial. Gen Hosp Psychiatry. 2003;25:115–123. doi: 10.1016/S0163-8343(02)00275-X.
    1. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:702–708. doi: 10.1136/bmj.328.7441.702.
    1. Casey D. Nurses’ perceptions, understanding and experiences of health promotion. J Clin Nurs. 2007;16:1039–1049. doi: 10.1111/j.1365-2702.2007.01640.x.
    1. Jerden L, Hillervik C, Hansson AC, Flacking R, Weinehall L. Experiences of Swedish community health nurses working with health promotion and a patient-held health record. Scand J Caring Sci. 2006;20:448–454. doi: 10.1111/j.1471-6712.2006.00427.x.
    1. Federal Public Service Health FCSaE. Health Care Facilities. Federal Public Service Health FCSaE, Brussels; 2011. 1-9-2010.
    1. Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004;31:143–164. doi: 10.1177/1090198104263660.
    1. Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000;55:68–78.
    1. Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982;92:111–135.
    1. Thompson D, Baranowski T, Buday R. Conceptual model for the design of a serious video game promoting self-management among youth with type 1 diabetes. J Diabetes Sci Technol. 2010;4:744–749.
    1. Flemish Institute of Health Promotion and Disease Prevention. Manual Health Promotion: Healthy eating and physical activity. Brussels, Flemish Institute of Health Promotion and Disease Prevention; 2007. 5-9-2010.
    1. Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999;28:319–326. doi: 10.1093/ije/28.2.319.
    1. National Heart Lung and Blood Institute. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. The Evidence Report. National Institutes of Health, Bethesda; 1998.
    1. Vandelanotte C, De Bourdeaudhuij I, Philippaerts R, Sjöström M, Sallis J. Reliability and validity of a computerized and Dutch version of the International Physical Activity Questionnaire (IPAQ) J Phys Act Health. 2005;2:63–75.
    1. Crouter SE, Schneider PL, Karabulut M, Bassett DR. Validity of 10 electronic pedometers for measuring steps, distance, and energy cost. Med Sci Sports Exerc. 2003;35:1455–1460. doi: 10.1249/01.MSS.0000078932.61440.A2.
    1. Vereecken CA, Covents M, Haynie D, Maes L. Feasibility of the Young Children’s Nutrition Assessment on the Web. J Am Diet Assoc. 2009;109:1896–1902. doi: 10.1016/j.jada.2009.08.013.
    1. de Beurs E, Zitman F, De Brief Symptom Inventory (BSI) De betrouwbaarheid en validiteit van een handzaam alternatief voor de SCL-90. Leids Universitair Medisch Centrum, Leiden; 2005.
    1. Osborn DP, Nazareth I, King MB. Risk for coronary heart disease in people with severe mental illness: cross-sectional comparative study in primary care. Br J Psychiatry. 2006;188:271–277. doi: 10.1192/bjp.bp.104.008060.
    1. Scott D, Happell B. The high prevalence of poor physical health and unhealthy lifestyle behaviours in individuals with severe mental illness. Issues Ment Health Nurs. 2011;32:589–597. doi: 10.3109/01612840.2011.569846.
    1. Van der Heyden J, Gisle L, Demarest S, Drieskens S, Hesse E, Tafforeau J. Health Interview Survey Belgium 2008. Scientific Institute for Public Health, Brussels; 2010.
    1. Dalton M, Cameron AJ, Zimmet PZ, Shaw JE, Jolley D, Dunstan DW. et al.Waist circumference, waist-hip ratio and body mass index and their correlation with cardiovascular disease risk factors in Australian adults. J Intern Med. 2003;254:555–563. doi: 10.1111/j.1365-2796.2003.01229.x.
    1. Janssen I, Katzmarzyk PT, Ross R. Waist circumference and not body mass index explains obesity-related health risk. Am J Clin Nutr. 2004;79:379–384.
    1. McDevitt J, Snyder M, Miller A, Wilbur J. Perceptions of barriers and benefits to physical activity among outpatients in psychiatric rehabilitation. J Nurs Scholarsh. 2006;38:50–55. doi: 10.1111/j.1547-5069.2006.00077.x.
    1. Shiner B, Whitley R, Van Citters AD, Pratt SI, Bartels SJ. Learning what matters for patients: qualitative evaluation of a health promotion program for those with serious mental illness. Health Promot Int. 2008;23:275–282. doi: 10.1093/heapro/dan018.
    1. Ussher M, Stanbury L, Cheeseman V, Faulkner G. Physical activity preferences and perceived barriers to activity among persons with severe mental illness in the United Kingdom. Psychiatr Serv. 2007;58:405–408. doi: 10.1176/appi.ps.58.3.405.
    1. Mauri M, Simoncini M, Castrogiovanni S, Lovieno N, Cecconi D, Dell’Agnello G. et al.A psychoeducational program for weight loss in patients who have experienced weight gain during antipsychotic treatment with olanzapine. Pharmacopsychiatry. 2008;41:17–23. doi: 10.1055/s-2007-992148.
    1. McKibbin CL, Patterson TL, Norman G, Patrick K, Jin H, Roesch S. et al.A lifestyle intervention for older schizophrenia patients with diabetes mellitus: a randomized controlled trial. Schizophr Res. 2006;86:36–44. doi: 10.1016/j.schres.2006.05.010.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe