Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Psychiatry
Published in: BMC Psychiatry 1/2014

Open Access 01-12-2014 | Study protocol

Changing the obesogenic environment of severe mentally ill residential patients: ELIPS, a cluster randomised study design

Authors: Anne Looijmans, Frederike Jörg, Robert A Schoevers, Richard Bruggeman, Ronald P Stolk, Eva Corpeleijn

Published in: BMC Psychiatry | Issue 1/2014

Login to get access

Abstract

Background

Severe mentally ill (SMI) patients have a reduced life expectancy of 13-30 years compared to the general population, largely due to an increased risk of cardiovascular mortality. Unhealthy lifestyle behaviours in SMI patients contribute to this increased risk. The obesogenic living environment of patients in residential facilities may even pose an extra risk. Although several studies have shown positive effects of lifestyle interventions on SMI patients' weight status, studies including residential patients and their obesogenic environment are scarce. This paper describes the Effectiveness of Lifestyle Interventions in PSychiatry trial (ELIPS). The goal of this trial is to improve cardiometabolic health in severe mentally ill residential patients by addressing the obesogenic environment.

Methods/design

The ELIPS study is a multi-site cluster randomised controlled trial (RCT) based on the principles of a pragmatic RCT. All residential and long-term clinical care teams of two large mental health care organisations in the North of the Netherlands serving SMI patients are invited to participate. The intervention is aimed at team level. Lifestyle coaches first develop a team specific lifestyle plan that tailors the ELIPS goals and protocol and then train teams on how to create a healthy environment and stimulate healthy behaviours in patients. After three months, teams take over the intervention after they have set out goals to achieve in the following nine months. In this phase, adherence to the lifestyle plan and pre-set goals is monitored. Patients in the control arm receive care as usual. Primary outcome measure is waist circumference at three and 12 months after baseline.

Discussion

ELIPS is different from previously published lifestyle intervention studies in three ways. First, it follows the principles of a pragmatic design, which enables the examination of effects in everyday practice. Second, by implementing the intervention at team level, we expect lifestyle activities to be maintained when interventionists leave. Last, by targeting the obesogenic environment we create a prerequisite for any sustainable health improvement, as patients can only make healthy choices in a healthy living environment.

Trial registration

Nederlands Trialregister NTR2720 (Dutch Trial Register, www.​trialregister.​nl). Registered 27 January 2011.
Literature
1.
Hert M, Correll CU, Bobes J, Cetkovich Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Möller H, Ndetei DM: 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.
McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA: Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the clinical antipsychotic trials of intervention effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005, 80 (1): 19-32. 10.1016/j.schres.2005.07.014.CrossRefPubMed
3.
Meyer JM, Stahl SM: The metabolic syndrome and schizophrenia. Acta Psychiatr Scand. 2009, 119 (1): 4-14. 10.1111/j.1600-0447.2008.01317.x.CrossRefPubMed
4.
Littrell KH, Hilligoss NM, Kirshner CD, Petty RG, Johnson CG: The effects of an educational intervention on antipsychotic-induced weight gain. J Nurs Scholarsh. 2003, 35 (3): 237-241. 10.1111/j.1547-5069.2003.00237.x.CrossRefPubMed
5.
Poulin MJ, Chaput JP, Simard V, Vincent P, Bernier J, Gauthier Y, Lanctot G, Saindon J, Vincent A, Gagnon S, Tremblay A: Management of antipsychotic-induced weight gain: prospective naturalistic study of the effectiveness of a supervised exercise programme. Aust N Z J Psychiatry. 2007, 41 (12): 980-989. 10.1080/00048670701689428.CrossRefPubMed
6.
Paris J, Mattick RP, McLaren J, Degenhardt L, Hall W, Voruganti LN, Whatham J, Rec D, Bard E, Parker G: Going beyond: an adventure-and recreation-based group intervention promotes well-being and weight loss in schizophrenia. Can J Psychiatr. 2006, 51: 575-580.
7.
Brown C, Goetz J, Hamera E: Weight loss intervention for people with serious mental illness: a randomized controlled trial of the RENEW program. Psychiatr Serv. 2011, 62 (7): 800-802. 10.1176/appi.ps.62.7.800.CrossRefPubMedPubMedCentral
8.
Daumit GL, Dickerson FB, Wang N, Dalcin A, Jerome GJ, Anderson CA, Young DR, Frick KD, Yu A, Gennusa JV: A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med. 2013, 368 (17): 1594-1602. 10.1056/NEJMoa1214530.CrossRefPubMedPubMedCentral
9.
Cabassa L, Ezell J, Lewis-Fernández R: Lifestyle interventions for adults with serious mental illness: a systematic literature review. Psychiatr Serv. 2010, 61 (8): 774-782. 10.1176/appi.ps.61.8.774.CrossRefPubMedPubMedCentral
10.
Gabriele J, Dubbert P, Reeves R: Efficacy of behavioural interventions in managing atypical antipsychotic weight gain. Obes Rev. 2009, 10 (4): 442-455. 10.1111/j.1467-789X.2009.00570.x.CrossRefPubMed
11.
Stanton R, Happell B: Exercise for mental illness: A systematic review of inpatient studies. Int J Ment Health Nurs. 2014, 23 (3): 232-242. 10.1111/inm.12045.CrossRefPubMed
12.
Cormac I, Ferriter M, Benning R, Saul C: Physical health and health risk factors in a population of long-stay psychiatric patients. Psychiatr Bull. 2005, 29 (1): 18-20. 10.1192/pb.29.1.18.CrossRef
13.
Swinburn B, Egger G, Raza F: Dissecting obesogenic environments: the development and application of a framework for identifying and prioritizing environmental interventions for obesity. Prev Med. 1999, 29 (6): 563-570. 10.1006/pmed.1999.0585.CrossRefPubMed
14.
Melamed Y, Stein-Reisner O, Gelkopf M, Levi G, Sivan T, Ilievici G, Rosenberg R, Weizman A, Bleich A: Multi-modal weight control intervention for people with persistent mental disorders. Psychiatr Rehabil J. 2008, 31 (3): 194-200. 10.2975/31.3.2008.194.200.CrossRefPubMed
15.
Weiss EC, Galuska DA, Kettel Khan L, Gillespie C, Serdula MK: Weight regain in US adults who experienced substantial weight loss, 1999-2002. Am J Prev Med. 2007, 33 (1): 34-40. 10.1016/j.amepre.2007.02.040.CrossRefPubMed
16.
Ross R, Bradshaw AJ: The future of obesity reduction: beyond weight loss. Nat Rev Endocrinol. 2009, 5 (6): 319-325. 10.1038/nrendo.2009.78.CrossRefPubMed
17.
Sbrocco T, Nedegaard RC, Stone JM, Lewis EL: Behavioral choice treatment promotes continuing weight loss: Preliminary results of a cognitive-behavioral decision-based treatment for obesity. J Consult Clin Psychol. 1999, 67 (2): 260-266. 10.1037/0022-006X.67.2.260.CrossRefPubMed
18.
Lutes LD, Winett RA, Barger SD, Wojcik JR, Herbert WG, Nickols-Richardson SM, Anderson ES: Small changes in nutrition and physical activity promote weight loss and maintenance: 3-month evidence from the ASPIRE randomized trial. Ann Behav Med. 2008, 35 (3): 351-357. 10.1007/s12160-008-9033-z.CrossRefPubMed
19.
Rothwell PM: External validity of randomised controlled trials:"to whom do the results of this trial apply?". Lancet. 2005, 365 (9453): 82-93. 10.1016/S0140-6736(04)17670-8.CrossRefPubMed
20.
Treweek S, Zwarenstein M: Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009, 10 (37): 9-
21.
Campbell MK, Piaggio G, Elbourne DR, Altman DG: Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012, 345: e5661-10.1136/bmj.e5661.CrossRefPubMed
22.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral
23.
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): 252-257. 10.1038/oby.2006.32.CrossRefPubMed
24.
Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C: Composition of the ESPEN Working Group: Bioelectrical impedance analysis-part I: review of principles and methods. Clin Nutr. 2004, 23 (5): 1226-1243. 10.1016/j.clnu.2004.06.004.CrossRefPubMed
25.
Sun SS, Chumlea WC, Heymsfield SB, Lukaski HC, Schoeller D, Friedl K, Kuczmarski RJ, Flegal KM, Johnson CL, Hubbard VS: 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): 331-340.PubMed
26.
Kay SR, Fiszbein A, Opler LA: The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987, 13 (2): 261-276. 10.1093/schbul/13.2.261.CrossRefPubMed
27.
Addington D, Addington J, Maticka-Tyndale E: Assessing depression in schizophrenia: the calgary depression scale. Br J Psychiatry. 1993, 163 (Suppl 22): 39-44.
28.
Priebe S, Huxley P, Knight S, Evans S: Application and results of the manchester short assessment of quality of life (MANSA). Int J Soc Psychiatry. 1999, 45 (1): 7-12. 10.1177/002076409904500102.CrossRefPubMed
29.
Wing JK, Curtis R, Beevor A: HoNOS: Health of the Nation Outcome Scales: report on research and development July 1993-December 1995. 1996, Royal College of Psychiatrists, London
30.
ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002, 166 (1): 111-117. 10.1164/ajrccm.166.1.at1102.
31.
Vancampfort D, Probst M, Sweers K, Maurissen K, Knapen J, De Hert M: Reliability, minimal detectable changes, practice effects and correlates of the 6-min walk test in patients with schizophrenia. Psychiatry Res. 2011, 187 (1): 62-67. 10.1016/j.psychres.2010.11.027.CrossRefPubMed
32.
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): 1163-1169. 10.1016/S0895-4356(03)00220-8.CrossRefPubMed
33.
Richtlijnen Goede Voeding 2006 [Guidelines for a Healthy Diet 2006. 2006, Health Council of the Netherlands, The Hague
34.
Hakkaart Van Roijen L, Straten A, Tiemens B, Donker M: Handleiding Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P). 2002
35.
Brazier JE, Roberts J: The estimation of a preference-based measure of health from the SF-12. Med Care. 2004, 42 (9): 851-859. 10.1097/01.mlr.0000135827.18610.0d.CrossRefPubMed
36.
McCrone P, Patel A, Knapp M, Schene A, Koeter M, Ammadeo F, Ruggeri M, Giessler A, Puschner B, Thornicroft G: 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
37.
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): 273-282. 10.1093/her/3.3.273.CrossRef
38.
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: 237-257. 10.1111/j.1559-1816.1995.tb01593.x.CrossRef
39.
Han T, Richmond P, Avenell A, Lean M: Waist circumference reduction and cardiovascular benefits during weight loss in women. Int J Obes Relat Metab Disord. 1997, 21 (2): 127-134. 10.1038/sj.ijo.0800377.CrossRefPubMed
40.
Hsieh FY, Lavori PW, Cohen HJ, Feussner JR: An overview of variance inflation factors for sample-size calculation. Eval Health Prof. 2003, 26 (3): 239-257. 10.1177/0163278703255230.CrossRefPubMed
41.
Engbers LH, van Poppel MN, Paw CA, Marijke JM, Van Mechelen W: Worksite health promotion programs with environmental changes: a systematic review. Am J Prev Med. 2005, 29 (1): 61-70. 10.1016/j.amepre.2005.03.001.CrossRefPubMed
42.
Cowan JA, Devine CM: Diet and body composition outcomes of an environmental and educational intervention among men in treatment for substance addiction. J Nutr Educ Behav. 2013, 45 (2): 154-158. 10.1016/j.jneb.2011.10.011.CrossRefPubMed
43.
Álvarez-Jiménez M, Martínez-García O, Pérez-Iglesias R, Ramírez ML, Vázquez-Barquero JL, Crespo-Facorro B: Prevention of antipsychoticinduced weight gain with early behavioural intervention in first-episode psychosis: 2-year results of a randomized controlled trial. Schizophr Res 2010, 116(1):16–19. 10.1016/j.schres.2009.10.012.CrossRefPubMed
44.
Rössner S, Hammarstrand M, Hemmingsson E, Neovius M, Johansson K: Long-term weight loss and weight-loss maintenance strategies. Obes Rev. 2008, 9 (6): 624-630. 10.1111/j.1467-789X.2008.00516.x.CrossRefPubMed
45.
Forsberg KA, Björkman T,, Sandman PO, Sandlund M: Physical health-a cluster randomized controlled lifestyle intervention among persons with a psychiatric disability and their staff. Nordic J Psychiatry. 2008, 62 (6): 486-495. 10.1080/08039480801985179.CrossRef
Metadata
Title
Changing the obesogenic environment of severe mentally ill residential patients: ELIPS, a cluster randomised study design
Authors
Anne Looijmans
Frederike Jörg
Robert A Schoevers
Richard Bruggeman
Ronald P Stolk
Eva Corpeleijn
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2014
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-014-0293-9

Other articles of this Issue 1/2014

BMC Psychiatry 1/2014 Go to the issue

Study protocol

Study protocol: safety correction of high dose antipsychotic polypharmacy in Japan

Research article

Mental health of indigenous school children in Northern Chile

Research article

Sleep complaints in adolescent depression: one year naturalistic follow-up study

Research article

Association between parental psychopathology and suicidal behavior among adult offspring: results from the cross-sectional South African Stress and Health survey

Research article

The household economic burden of eating disorders and adherence to treatment in Australia

Research article

Validation of the multi-dimensional scale of perceived social support (MSPSS) and the relationship between social support, intimate partner violence and antenatal depression in Malawi