The effectiveness and applicability of different lifestyle interventions for enhancing wellbeing: the study design for a randomized controlled trial for persons with metabolic syndrome risk factors and psychological distress

BMC Public Health

Marjukka Kolehmainen²  Miikka Ermes⁵  Osmo Saarelma¹  Eija Kutinlahti¹  Jaana Laitinen⁶  Heli Järnefelt⁶  Jussi Pihlajamäki²  Leila Karhunen²  Aino Ahtinen⁵  Kirsikka Kaipainen⁵  Elina Mattila⁵  Katri Peuhkuri⁷  Tero Myllymäki³  Urho M Kujala⁴  Sampsa Puttonen⁶  Riitta Korpela⁷  Sanni Rantala⁷  Elina Järvelä²  Essi Sairanen³  Raimo Lappalainen³ 

[1] Duodecim Medical Publications Ltd, Helsinki, Finland;Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, Kuopio, Finland;Department of Psychology, University of Jyväskylä, Ylistönmäentie 33, P. O. Box 35, 40014 Jyväskylä, Finland;Department of Health Sciences, University of Jyväskylä, Jyväskylä, Finland;VTT Technical Research Centre of Finland, Tampere, Finland;Finnish Institute of Occupational Health, Helsinki, Finland;Institute of Biomedicine, University of Helsinki, Helsinki, Finland

关键词: Technology-aided interventions;    Web-based intervention;    Mobile application;    Cognitive behavioral therapy;    Acceptance and Commitment Therapy;    Stress;    Obesity;    Well-being;    Lifestyle;   

Others  :  1131705
DOI  :  10.1186/1471-2458-14-310

 received in 2014-03-10, accepted in 2014-03-25,  发布年份 2014

【 摘 要 】

Background

Obesity and stress are among the most common lifestyle-related health problems. Most of the current disease prevention and management models are not satisfactorily cost-effective and hardly reach those who need them the most. Therefore, novel evidence-based controlled interventions are necessary to evaluate models for prevention and treatment based on self-management. This randomized controlled trial examines the effectiveness, applicability, and acceptability of different lifestyle interventions with individuals having symptoms of metabolic syndrome and psychological distress. The offered interventions are based on cognitive behavioral approaches, and are designed for enhancing general well-being and supporting personalized lifestyle changes.

Methods/Design

339 obese individuals reporting stress symptoms were recruited and randomized to either (1) a minimal contact web-guided Cognitive Behavioral Therapy-based (CBT) intervention including an approach of health assessment and coaching methods, (2) a mobile-guided intervention comprising of mindfulness, acceptance and value-based exercises, (3) a face-to-face group intervention using mindfulness, acceptance and value-based approach, or (4) a control group. The participants were measured three times during the study (pre = week 0, post = week 10, and follow-up = week 36). Psychological well-being, lifestyles and habits, eating behaviors, and user experiences were measured using online surveys. Laboratory measurements for physical well-being and general health were performed including e.g. liver function, thyroid glands, kidney function, blood lipids and glucose levels and body composition analysis. In addition, a 3-day ambulatory heart rate and 7-day movement data were collected for analyzing stress, recovery, physical activity, and sleep patterns. Food intake data were collected with a 48 -hour diet recall interview via telephone. Differences in the effects of the interventions would be examined using multiple-group modeling techniques, and effect-size calculations.

Discussion

This study will provide additional knowledge about the effects of three low intensity interventions for improving general well-being among individuals with obesity and stress symptoms. The study will show effects of two technology guided self-help interventions as well as effect of an acceptance and value–based brief group intervention. Those who might benefit from the aforesaid interventions will increase knowledge base to better understand what mechanisms facilitate effects of the interventions.

Trial registration

Current Clinical Trials NCT01738256, Registered 17 August, 2012.

【 授权许可】

   
2014 Lappalainen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

Figure 5.

【 参考文献 】

• [1]Eckel RH, Grundy SM, Zimmet PZ: The metabolic syndrome. Lancet 2005, 365(9468):1415-1428.
• [2]Galassi A, Reynolds K, He J: Metabolic syndrome and risk of cardiovascular disease: A meta-analysis. Am J Med 2006, 119(10):812-819.
• [3]Lindström J, Peltonen M, Eriksson J, Ilanne-Parikka P, Aunola S, Keinänen-Kiukaanniemi S, Uusitupa M, Tuomilehto J: 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.
• [4]Gillies CL, Lambert PC, Abrams KR, Sutton AJ, Cooper NJ, Hsu RT, Davies MJ, Khunti K: Different strategies for screening and prevention of type 2 diabetes in adults: Cost effectiveness analysis. Br Med J 2008, 336(7654):1180-1185.
• [5]Kouvonen A, Kivimaki M, Cox SJ, Cox T, Vahtera J: Relationship between work stress and body mass index among 45,810 female and male employees. Psychosom Med 2005, 67(4):577-583.
• [6]Iversen LB, Strandberg-Larsen K, Prescott E, Schnohr P, Rod NH: Psychosocial risk factors, weight changes and risk of obesity: The copenhagen city heart study. Eur J Epidemiol 2012, 27(2):119-130.
• [7]Kottwitz MU, Grebner S, Semmer NK, Tschan F, Elfering A: Social stress at work and change in women's body weight. Ind Health 2014.
• [8]Milczarek M, Schneider E, Rial González E: OSH in figures: Stress at work – facts and figures. European Risk Observatory Report. Luxembourg: Office for Official Publications of the European Communities: European Agency for Safety and Health at Work; 2009:9.
• [9]Kypri K, Saunders JB, Williams SM, McGee RO, Langley JD, Cashell Smith ML, Gallagher SJ: Web based screening and brief intervention for hazardous drinking: A double blind randomized controlled trial. Addiction 2004, 99(11):1410-7.
• [10]Hurling R, Catt M, Boni MD, Fairley BW, Hurst T, Murray P, Richardson A, Sodhi JS: Using internet and mobile phone technology to deliver an automated physical activity program: Randomized controlled trial. J Med Intern Res 2007, 9(2):e7.
• [11]Shahab L, McEwen A: Online support for smoking cessation: A systematic review of the literature. Addiction 2009, 104(11):1792-804.
• [12]Arem H, Irwin M: A review of web-based weight loss interventions in adults. Obes Rev 2011, 12(5):e236-43.
• [13]Webb TL, Joseph J, Yardley L, Michie S: Using the internet to promote health behavior change: A systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res 2010, 12(1):97-114.
• [14]Spring B, Schneider K, McFadden HG, Vaughn J, Kozak AT, Smith M, Moller AC, Epstein LH, DeMott A, Hedeker D: Multiple behavior changes in diet and activity: A randomized controlled trial using mobile technology. Arch Intern Med 2012, 172(10):789-96.
• [15]Cuijpers P, van Straten A, Andersson G: Internet-administered cognitive behavior therapy for health problems: A systematic review. J Behav Med 2008, 31(2):169-77.
• [16]Bennett GG, Glasgow RE: The delivery of public health interventions via the internet: Actualizing their potential. Annu Rev Public Health 2009, 30:273-92.
• [17]Bennett-Levy J, Richards D, Farrand P, Christensen H, Griffiths K: Oxford Guide to Low Intensity CBT Interventions. New York, NY: Oxford University Press; 2010.
• [18]Kashdan TB, Rottenberg J: Psychological flexibility as a fundamental aspect of health. Clin Psychol Rev 2010, 30(7):865-78.
• [19]Cavanagh K, Strauss C, Forder L, Jones F: Can mindfulness and acceptance be learnt by self-help?: A systematic review and meta-analysis of mindfulness and acceptance-based self-help interventions. Clin Psychol Rev 2014, 34(2):118-129.
• [20]Nevanperä N, Lappalainen R, Kuosma E, Hopsu L, Uitti J, Laitinen J: Psychological flexibility, occupational burnout and eating behavior among working women. Open J Prev Med 2013, 3(4):355-361.
• [21]Hayes SC, Strosahl KD, Wilson KG: Acceptance and Commitment Therapy: The Process and Practice of Mindful Change. New York, NY: Guilford Press; 2011.
• [22]Gregg JA, Callaghan GM, Hayes SC, Glenn-Lawson JL: Improving diabetes self-management through acceptance, mindfulness, and values: A randomized controlled trial. J Consult Clin Psychol 2007, 75(2):336-43.
• [23]Nes AAG, Eide H, Kristjánsdóttir ÓB, van Dulmen S: Web-based, self-management enhancing interventions with e-diaries and personalized feedback for persons with chronic illness: A tale of three studies. Patient Educ Couns 2013, 93(3):451-8.
• [24]Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J: Acceptance and commitment therapy: Model, processes and outcomes. Behav Res Ther 2006, 44(1):1-25.
• [25]Ruiz FJ: Acceptance and commitment therapy versus traditional cognitive behavioral therapy: A systematic review and meta-analysis of current empirical evidence. Int J Psychol Psychol Ther 2012, 12(3):333-357.
• [26]Hesser H, Gustafsson T, Lundén C, Henrikson O, Fattahi K, Johnsson E, Bendelin N, Furmark T, Anderson G: A randomized controlled trial of internet-delivered cognitive behavior therapy and acceptance and commitment therapy in the treatment of tinnitus. J Consult Clin Psychol 2012, 80(4):649.
• [27]Buhrman M, Skoglund A, Husell J, Bergström K, Gordh T, Hursti T, Bendelin N, Furmark T, Anderson G: Guided internet-delivered acceptance and commitment therapy for chronic pain patients: A randomized controlled trial. Behav Res Ther 2013, 51(6):307-15.
• [28]Lappalainen P, Kaipainen K, Lappalainen R, Hoffren H, Myllymaki T, Kinnunen M, Mattila E, Happonen AP, Rusko H, Korhonen I: Feasibility of a personal health technology-based psychological intervention for men with stress and mood problems: Randomized controlled pilot trial. J Med Intern Res 2013, 2(1):e1.
• [29]Ahtinen A, Mattila E, Välkkynen P, Kaipainen K, Vanhala T, Ermes M, Sairanen E, Myllymäki T, Lappalainen R: Mobile mental wellness training for stress management: Feasibility and design implications based on a one-month field study. J Med Internet Res 2013., 1(2)
• [30]Ly KH, Dahl J, Carlbring P, Andersson G: Development and initial evaluation of a smartphone application based on acceptance and commitment therapy. SpringerPlus 2012, 1:11. BioMed Central Full Text
• [31]Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A: The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: A systematic review. PLoS Med 2013, 10(1):n/a-e1001362.
• [32]Makowska Z, Merecz D, Moscicka A, Kolasa W: The validity of general health questionnaires, GHQ-12 and GHQ-28, in mental health studies of working people. Int J Occup Med Environ Health 2002, 15(4):353-62.
• [33]Peltonen M, Saarikoski L, Lund L, Salminen I, Laatikainen T, Jousilahti P, Männistö S, Vartiainen E: Kansallinen FINRISKI 2007-terveystutkimus: Tutkimuksen toteutus ja tulokset: Menetelmät. Helsinki, Finland: National Public Health Institute, Finland. B36/2008; 2008.
• [34]Laliberte M, McCabe RE, Taylor V: The Cognitive Behavioral Workbook for Weight Management: A Step-By-Step Program. Oakland, CA: New Harbinger Publications; 2009.
• [35]Edinger JD, Carney CE: Overcoming Insomnia: A Cognitive-Behavioral Therapy Approach Therapist Guide: A Cognitive-Behavioral Therapy Approach Therapist Guide. New York, NY: Oxford University Press; 2008.
• [36]Epstein EE, McCrady BS: A Cognitive-Behavioral Treatment Program for Overcoming Alcohol Problems: Therapist Guide. New York, NY, US: Oxford University Press, New York, NY; 2009.
• [37]Perkins KA, Conklin CA, Levine MD: Cognitive-Behavioral Therapy for Smoking Cessation: A Practical Guidebook to the Most Effective Treatments. New York, NY: CRC Press; 2008.
• [38]Emmons RA, McCulough ME: Counting blessings versus burdens: An experimental investigation of gratitude and subjective well-being in daily life. J Pers Soc Psychol 2003, 84(2):377-389.
• [39]King LA: The health benefits of writing about life goals. Person Soc Psychol Bull 2001, 27(7):798-807.
• [40]Seligman MEP: Authentic Happiness: Using the New Positive Psychology to Realize Your Potential for Lasting Fulfillment. New York, NY, US: Free Press, New York, NY; 2002.
• [41]Seligman MEP, Steen TA, Park N, Peterson C: Positive psychology progress: Empirical validation of interventions. Am Psychol 2005, 60(5):410-21.
• [42]Joutsenniemi K, Langinvainio H, Mattila A, Saarelma O, Pankakoski M, Lönnqvist J, Mustonen P: Happiness, health and work. 2012. In press
• [43]Cohen S, Kamarck T, Mermelstein R: A global measure of perceived stress. J Health Soc Behav 1983, 24(4):385-96.
• [44]Beck AT, Steer RA, Ball R, Ranieri WF: Comparison of beck depression inventories-IA and-II in psychiatric outpatients. J Pers Assess 1996, 67(3):588-97.
• [45]Antonovsky A: Unraveling the Mystery of Health: How People Manage Stress and Stay Well. San Francisco, CA: Jossey-Bass; 1987.
• [46]Antonovsky A: The structure and properties of the sense of coherence scale. Soc Sci Med 1993, 36(6):725-733.
• [47]Aalto A, Aro AR, Teperi J: RAND-36 terveyteen liittyvän elämänlaadun mittarina: Mittarin luotettavuus ja suomalaiset väestöarvot. Helsinki: Stakes; 1999.
• [48]Hays RD, Sherbourne CD, Mazel RM: The rand 36‒item health survey 1.0. Health Econ 1993, 2(3):217-27.
• [49]Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD: Preliminary psychometric properties of the acceptance and action Questionnaire–II: A revised measure of psychological inflexibility and experiential avoidance. Behav Ther 2011, 42(4):676-88.
• [50]Lillis J, Hayes SC: Measuring avoidance and inflexibility in weight related problems. Int J Behav Consult Ther 2007, 4(1):30-40.
• [51]Gifford EV, Kohlenberg BS, Hayes SC, Antonuccio DO, Piasecki MM, Rasmussen-Hall ML, Palm KM: Acceptance-based treatment for smoking cessation. Behav Ther 2004, 35(4):689-705.
• [52]Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L: Using self-report assessment methods to explore facets of mindfulness. Assessment 2006, 13(1):27-45.
• [53]Kujala UM, Kaprio J, Sarna S, Koskenvuo M: Relationship of leisure-time physical activity and mortality: The finnish twin cohort. JAMA 1998, 279(6):440-4.
• [54]Waller K, Kaprio J, Kujala U: Associations between long-term physical activity, waist circumference and weight gain: A 30-year longitudinal twin study. Int J Obes 2008, 32(2):353-61.
• [55]Buysse DJ, Ancoli-lsrael S, Edinger JD, Lichstein KL, Morin CM: Recommendations for a standard research assessment of insomnia. J Sleep Sleep Disord Res 2006, 29(9):1155-73.
• [56]Partinen M, Gislason T: Basic nordic sleep questionnaire (BNSQ): A quantitated measure of subjective sleep complaints. J Sleep Res 1995, 4(s1):150-5.
• [57]Johns MW: A new method for measuring daytime sleepiness: The epworth sleepiness scale. J Sleep Sleep Disord Res 1991, 14(6):540-5.
• [58]Paturi M: Ruokien annoskuvakirja. Helsinki: National Public Health Institute; 2006.
• [59]Leppälä J, Lagström H, Kaljonen A, Laitinen K: Construction and evaluation of a self-contained index for assessment of diet quality. Scand J Public Health 2010, 38(8):794-802.
• [60]Tylka TL, Wilcox JA: Are intuitive eating and eating disorder symptomatology opposite poles of the same construct? J Couns Psychol 2006, 53(4):474.
• [61]Karlsson J, Persson L, 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.
• [62]Krall JS, Lohse B: Cognitive testing with female nutrition and education assistance program participants informs validity of the satter eating competence inventory. J Nutr Educ Behav 2010, 42(4):277-83.
• [63]Krall JS, Lohse B: Validation of a measure of the satter eating competence model with low-income females. Int J Behav Nutr Phys Act 2011, 8(1):26. BioMed Central Full Text
• [64]Satter E: Eating competence: Definition and evidence for the satter eating competence model. J Nutr Educ Behav 2007, 39(5):S142-53.
• [65]Roininen K, Lähteenmäki L, Tuorila H: Quantification of consumer attitudes to health and hedonic characteristics of foods. Appetite 1999, 33(1):71-88.
• [66]Tuomi K, Oja G: Work Ability Index. Helsinki: Finnish Institute of Occupational Health Helsinki; 1998.
• [67]Camm A, Malik M, Bigger J, Breithardt G, Cerutti S, Cohen R, Coumel P, Fallen EL, Kennedy HL, Kleiger RE: Heart rate variability: Standards of measurement, physiological interpretation and clinical use. task force of the european society of cardiology and the north american society of pacing and electrophysiology. Circulation 1996, 93(5):1043-65.
• [68]Lamminmäki E, Saarinen A, Lötjönen J, Partinen M, Korhonen I: Differences in light sleep and deep sleep measured with IST vivago® WristCare. EMBEC Proc 2005., 11(1)
• [69]Lotjonen J, Korhonen I, Hirvonen K, Eskelinen S, Myllymaki M, Partinen M: Automatic sleep-wake and nap analysis with a new wrist worn online activity monitoring device vivago WristCare®. Sleep-New York Then Westchester 2003, 26(1):86-90.
• [70]Muthén LK, Muthén BO: Statistical analysis with latent variables. Los Angeles, CA: Muthén & Muthén; 1998:1998-2012. [Mplus User’s Guide]
• [71]Cohen J: Statistical Power Analysis for the Behavioral Sciences (Rev. ed.). Hillsdale, NJ, England: Lawrence Erlbaum Associates, Inc, Hillsdale, NJ; 1977.
• [72]Kohtala A, Lappalainen R, Savonen L, Timo E, Tolvanen A: A four-session acceptance and commitment therapy based intervention for depressive symptoms delivered by masters degree level psychology students: A preliminary study. Behav Cogn Psychother 2013, 11(11):1-14.
• [73]World Health Organization: Regional Office for Europe. Mental health: Facing the challenges, building solutions: Report from the WHO European Ministerial Conference of Helsinki. Copenhagen: WHO Regional Office for Europe; 2005.
• [74]Blumenthal R, Endicott J: Barriers to seeking treatment for major depression. Depress Anxiety 1997, 4(6):273-8.
• [75]Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS: Lifetime and 12-month prevalence of DSM-III—R psychiatric disorders in the united states: Results from the national comorbidity study. Arch Gen Psychiatry 1994, 51(1):8-19.
• [76]Herbert JD, Forman EM: Acceptance and Mindfulness in Cognitive Behavior Therapy: Understanding and Applying the New Therapies. Hoboken, New Jersey: John Wiley & Sons; 2011.
• [77]McCracken L: Mindfulness and Acceptance in Behavioral Medicine: Current Theory and Practice. Oakland, CA: New Harbinger Publications; 2011.