Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial

Vera Salvo, Jean Kristeller, Jesus Montero Marin, Adriana Sanudo, Bárbara Hatzlhoffer Lourenço, Mariana Cabral Schveitzer, Vania D'Almeida, Héctor Morillo, Suely Godoy Agostinho Gimeno, Javier Garcia-Campayo, Marcelo Demarzo, Vera Salvo, Jean Kristeller, Jesus Montero Marin, Adriana Sanudo, Bárbara Hatzlhoffer Lourenço, Mariana Cabral Schveitzer, Vania D'Almeida, Héctor Morillo, Suely Godoy Agostinho Gimeno, Javier Garcia-Campayo, Marcelo Demarzo

Abstract

Background: Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training.

Methods/design: A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods.

Discussion: This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of this study confirm the effectiveness of mindfulness programmes in this population, it will be possible to improve quality of life and health while optimising public resources and reaching a greater number of people. In addition, on the basis of the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy.

Trial registration: ClinicalTrials.gov, NCT02893150 . Registered retrospectively on 30 March 2017.

Keywords: Mindfulness-Based Eating Awareness Training (MB-EAT); Nutritional status; Obesity; Primary health care; Randomised controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the ethics committee of the Universidade Federal de São Paulo (CAAE; protocol 55970016.9.0000.5505). Informed consent will be obtained from all participants.

Consent for publication

Consent will be obtained from all participants.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Diagram of planned study flow. TAU Treatment as usual, MBHP Mindfulness-Based Health Promotion, MB-EAT Mindfulness-based eating awareness training
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram. Abbreviations: TAU, Treatment as usual; MBHP, Mindfulness based Health Promotion; MB-EAT, Mindfulness Based Eating Awareness Training; HADS, Hospital Anxiety and Depression Scale; BES, Binge Eating Scale; BES, Binge Eating Scale; BPAAT, Brief Physical Activity Assessment Tool; DEBQ, Dutch Food Behavior Questionnaire; EAT 26, Eating Attitude Test; FFQ, Food Frequency Questionnaire; HADS, Hospital Anxiety and Depression Scale, HBA1C, glycated hemoglobin; BDNF, Brain Derived Neurotrophic Factor; MAAS, Mindful Attention Awareness Scale; SCS, Self Compassion Scale; T1: 8 or 10 weeks Post Intervention, (TAU, TAU+ MBHP, TAU + MB-EAT); T2: 3 Months Post Intervention (TAU, TAU+ MBHP, TAU + MB-EAT); US-CRP, Ultra-sensitive C Reactive Protein

References

    1. Básica BM da SS de A à SD de A . Estratégias para o cuidado da pessoa com doença crônica: obesidade. 2014.
    1. FAO/OPS. 2016 América latina y el caribe: panorama de la seguridad alimentaria y nutricional. Santiago, Chile: Organización de las Naciones Unidas para la Alimentación y la Agricultura y la Organización Panamericana de la Salud; 2017. . Accessed 2 July 2017.
    1. IBGE . Instituto Brasileiro de Geografia e Estatística, Coordenação de Trabalho e Rendimento. Pesquisa de Orçamentos Familiares: 2008–2009. Análise do Consumo Alimentar Pessoal no Brasil. 2011.
    1. de Oliveira DC, de Sá CP, Gomes AMT, de Souza Ramos R, Pereira NA, Rocha dos Santos WC. Brazilian National Health Policy: health professionals’ social representations [in Portuguese] Cad Saude Publica. 2008;24:197–206. doi: 10.1590/S0102-311X2008000100020.
    1. Brasil Ministério da Saúde . Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Cadernos de Atenção Básica no 12. Obesidade. 2006.
    1. Berg R. Uma análise freudiana da obesidade. 2008. p. 136.
    1. Rogers JM, Ferrari M, Mosely K, Lang CP, Brennan L. Mindfulness-based interventions for adults who are overweight or obese: a meta-analysis of physical and psychological health outcomes. Obes Rev. 2017;18:51–67. doi: 10.1111/obr.12461.
    1. Sedlmeier P, Eberth J, Schwarz M, Zimmermann D, Haarig F, Jaeger S, et al. The psychological effects of meditation: a meta-analysis. Psychol Bull. 2012;138:1139–1171. doi: 10.1037/a0028168.
    1. Keng SL, Smoski MJ, Robins CJ. Effects of mindfulness on psychological health: a review of empirical studies. Clin Psychol Rev. 2011;31:1041–1056. doi: 10.1016/j.cpr.2011.04.006.
    1. Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003;84:822–848. doi: 10.1037/0022-3514.84.4.822.
    1. Camilleri GM, Méjean C, Bellisle F, Hercberg S, Péneau S. Association between mindfulness and weight status in a general population from the NutriNet-Santé study. PLoS One. 2015;10:e0127447. doi: 10.1371/journal.pone.0127447.
    1. O’Reilly G, Cook L, Spruijt-Metz D, Black DS. Mindfulness-based interventions for obesity-related eating behaviors: a literature review. Obes Rev. 2014;15:453–461. doi: 10.1111/obr.12156.
    1. Carlson LE. Mindfulness-based interventions for physical conditions: a narrative review evaluating levels of evidence. ISRN Psychiatry. 2012;2012:651583. doi: 10.5402/2012/651583.
    1. Kaliman P, Álvarez-López MJ, Cosín-Tomás M, Rosenkranz MA, Lutz A, Davidson RJ. Rapid changes in histone deacetylases and inflammatory gene expression in expert meditators. Psychoneuroendocrinology. 2014;40:96–107. doi: 10.1016/j.psyneuen.2013.11.004.
    1. Kristeller JL, Hallett CB. An exploratory study of a meditation-based intervention for binge eating disorder. J Health Psychol. 1999;4:357–363. doi: 10.1177/135910539900400305.
    1. Kristeller J, Wolever RQ, Sheets V. Mindfulness-Based Eating Awareness Training (MB-EAT) for binge eating: a randomized clinical trial. Mindfulness (N Y) 2014;5:282–297. doi: 10.1007/s12671-012-0179-1.
    1. Godfrey KM, Gallo LC, Afari N. Mindfulness-based interventions for binge eating: a systematic review and meta-analysis. J Behav Med. 2015;38:348–362. doi: 10.1007/s10865-014-9610-5.
    1. Daubenmier J, Kristeller J, Hecht FM, Maninger N, Kuwata M, Jhaveri K, et al. Mindfulness intervention for stress eating to reduce cortisol and abdominal fat among overweight and obese women: an exploratory randomized controlled study. J Obes. 2011;2011:651936. doi: 10.1155/2011/651936.
    1. Mason AE, Epel ES, Kristeller J, Moran PJ, Dallman M, Lustig RH, et al. Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial. J Behav Med. 2016;39:201–213. doi: 10.1007/s10865-015-9692-8.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55. doi: 10.1016/j.ijsu.2011.10.001.
    1. Zwarentein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement [in Chinese] Zhong Xi Yi Jie He Xue Bao. 2009;7:392–397.
    1. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39:175–191. doi: 10.3758/BF03193146.
    1. J P, C T, C A, Bahia L MJ. The Brazilian health system: history, advances, and challenges. Lancet. 2011;377:1778–1797. doi: 10.1016/S0140-6736(11)60054-8.
    1. Pinto AGA, Jorge MSB, Vasconcelos MGF, Sampaio JJC, Lima GP, Bastos VC, et al. Matrixing support as an instrument of primary healthcare in mental health: multiple views and devices for resolution. Cien Saude Colet. 2012;17:653–660. doi: 10.1590/S1413-81232012000300011.
    1. Bighetti F. Translation and validation of the Eating Attitudes Test (EAT-26) in female adolescents in Ribeirão Preto city – SP [in Portuguese]. Master’s thesis, Nursing School of Ribeirão Preto, Universidade de São Paulo, Brasil. 10.11606/D.22.2003.tde-12042004-234230.
    1. Wardle J. Eating style: a validation-study of the Dutch Eating Behaviour Questionnaire in normal subjects and women with eating disorders. J Psychosom Res. 1987;31:161–169. doi: 10.1016/0022-3999(87)90072-9.
    1. Estilos de comer DEBQ Almeida 2001.
    1. Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7:47–55. doi: 10.1016/0306-4603(82)90024-7.
    1. Freitas S, Lopes CS, Coutinho W, Appolinario JC. Translation and adaptation into Portuguese of the Binge-Eating Scale [in Portuguese] Rev Bras Psiquiatr. 2001;23:215–220. doi: 10.1590/S1516-44462001000400008.
    1. de de Barros VV, Kozasa EH, Weiss de Souza IC, Ronzani TM. Validity evidence of the Brazilian version of the Mindful Attention Awareness Scale (MAAS) Psicol Reflex Crit. 2015;28:87–95. doi: 10.1590/1678-7153.201528110.
    1. Neff K. Self-compassion: an alternative conceptualization of a healthy attitude toward oneself. Self Identity. 2003;2:85–101. doi: 10.1080/15298860309032.
    1. de Souza LK, Hutz CS. Adaptation of the Self-Compassion Scale for use in Brazil: evidence of construct validity. Temas Psicol. 2016;24:159–172. doi: 10.9788/TP2016.1-11.
    1. Germer CK. The mindful path to self-compassion: freeing yourself from destructive thoughts and emotions. New York: Guilford Press; 2009.
    1. Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011;18:250–255. doi: 10.1002/cpp.702.
    1. Neff KD, Kirkpatrick KL, Rude SS. Self-compassion and adaptive psychological functioning. J Res Pers. 2007;41:139–154. doi: 10.1016/j.jrp.2006.03.004.
    1. Snaith RP, Zigmond AS. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Marcolino JÁM, Mathias LADST, Piccinini Filho L, Guaratini ÁA, Suzuki FM, Alli LAC. Escala hospitalar de ansiedade e depressão: estudo da validade de critério e da confiabilidade com pacientes no pré-operatório. Rev Bras Anestesiol. 2007;57:52–62. doi: 10.1590/S0034-70942007000100006.
    1. Puig Ribera A, Peña Chimenis Ò, Romaguera Bosch M, Duran Bellido E, Heras Tebar A, Solà Gonfaus M, et al. Cómo identificar la inactividad física en atención primaria: validación de las versiones Catalana y Española de 2 cuestionarios breves. Aten Primaria. 2012;44:485–493. doi: 10.1016/j.aprim.2012.01.005.
    1. Puig-Ribera A, Martín-Cantera C, Puigdomenech E, Real J, Romaguera M, Magdalena-Belio JF, et al. Screening physical activity in family practice: validity of the Spanish version of a brief physical activity questionnaire. PLoS One. 2015;10:e0136870. doi: 10.1371/journal.pone.0136870.
    1. Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997;12:38–48. doi: 10.4278/0890-1171-12.1.38.
    1. de Menezes MC, Mingoti SA, Cardoso CS, de Deus Mendonça R, ACS L. Intervention based on Transtheoretical Model promotes anthropometric and nutritional improvements — a randomized controlled trial. Eat Behav. 2015;17:37–44. doi: 10.1016/j.eatbeh.2014.12.007.
    1. Chang CT. Applicability of the stages of change and Weight Efficacy Lifestyle Questionnaire with natives of Sarawak, Malaysia. Rural Remote Health. 2007;7:864.
    1. Hawkins DS, Hornsby PP, Schorling JB. Stages of change and weight loss among rural African American women. Obes Res. 2001;9:59–67. doi: 10.1038/oby.2001.8.
    1. de Salvo VLMA, SGA G. Reproducibility and validity of a food frequency questionnaire [in Portuguese] Rev Saude Publica. 2002;36:505–512. doi: 10.1590/S0034-89102002000400018.
    1. World Health Organization (WHO) Obesity: preventing and managing the global epidemic: report of a WHO consultation (WHO Technical Report Series 894) Geneva: WHO; 2000.
    1. Faria SL, Faria OP, Cardeal MDA, Ito MK. Validation study of multi-frequency bioelectrical impedance with dual-energy X-ray absorptiometry among obese patients. Obes Surg. 2014;24:1476–1480. doi: 10.1007/s11695-014-1190-5.
    1. Rodrigues AE, Marostegan PF, Mancini MC, Dalcanale L, de Melo ME, Cercato C, et al. Analysis of resting metabolic rate evaluated by indirect calorimetry in obese women with low and high caloric intake [in Portuguese] Arq Bras Endocrinol Metabol. 2008;52:76–84. doi: 10.1590/S0004-27302008000100011.
    1. de Melo CM, Tirapegui J, Ribeiro SML. Human energetic expenditure: concepts, assessment methods and relationship to obesity [in Portuguese] Arq Bras Endocrinol Metabol. 2008;52:452–464. doi: 10.1590/S0004-27302008000300005.
    1. São Paulo (cidade) Secretaria da Saúde. Programas E Políticas De Saúde Secretaria Municipal Da Saúde. Cad Coleta Exames Lab I Bras. 2006. pp. 1–120.
    1. Tang YY, Hölzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci. 2015;16:213–225. doi: 10.1038/nrn3916.
    1. Demarzo MMP, Cebolla A, Garcia-Campayo J. The implementation of mindfulness in healthcare systems: a theoretical analysis. Gen Hosp Psychiatry. 2015;37:166–171. doi: 10.1016/j.genhosppsych.2014.11.013.
    1. Kabat-Zinn J. Mindfulness-based stress reduction (MBSR) Constr Hum Sci. 2003;8:73–107.
    1. Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982;4:33–47. doi: 10.1016/0163-8343(82)90026-3.
    1. Demarzo M, Garcia-Campayo J. Manual prático de mindfulness: curiosidade e aceitação. São Paulo: Palas Athena; 2015.
    1. Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, et al. Efficacy of mindfulness-based cognitive therapy in prevention of depressive relapse: an individual patient data meta-analysis from randomized trials. JAMA Psychiatry. 2016;73:565–574. doi: 10.1001/jamapsychiatry.2016.0076.
    1. Cusens B, Duggan GB, Thorne K, Burch V. Evaluation of the Breathworks Mindfulness-based pain management programme: effects on well-being and multiple measures of mindfulness. Clin Psychol Psychother. 2010;17:63–78.
    1. Kristeller JL, Wolever RQ. Mindfulness-based eating awareness training for treating binge eating disorder: the conceptual foundation. Eat Disord. 2011;19:49–61. doi: 10.1080/10640266.2011.533605.
    1. StataCorp. Stata 14 Base Reference Manual. College Station: Stata Press; 2015.
    1. Kerrigan D, Johnson K, Stewart M, Magyari T, Hutton N, Ellen JM, et al. Perceptions, experiences, and shifts in perspective occurring among urban youth participating in a mindfulness-based stress reduction program. Complement Ther Clin Pract. 2011;17:96–101. doi: 10.1016/j.ctcp.2010.08.003.
    1. Nakamura E. The ethnographic method in health research: an anthropological reflection. Saude Soc. 2011;20:95–103. doi: 10.1590/S0104-12902011000100012.
    1. Mantzios M, Wilson JC. Mindfulness, eating behaviours, and obesity: a review and reflection on current findings. Curr Obes Rep. 2015;4:141–146. doi: 10.1007/s13679-014-0131-x.
    1. Olson KL, Emery CF. Mindfulness and weight loss: a systematic review. Psychosom Med. 2015;77:59–67. doi: 10.1097/PSY.0000000000000127.
    1. Katterman SN, Kleinman BM, Hood MM, Nackers LM, Corsica JA. Mindfulness meditation as an intervention for binge eating, emotional eating, and weight loss: a systematic review. Eat Behav. 2014;15:197–204. doi: 10.1016/j.eatbeh.2014.01.005.
    1. Carrière K, Khoury B, Günak MM, Knäuper B. Mindfulness-based interventions for weight loss: a systematic review and meta-analysis. Obes Rev. 2018;19:164–177. doi: 10.1111/obr.12623.
    1. Kristeller J. Mindfulness, wisdom and eating: applying a multi-domain model of meditation effects. Constr Hum Sci. 2003;8:1–15.
    1. Black DS, Semple RJ, Pokhrel P, Grenard JL. Component processes of executive function—mindfulness, self-control, and working memory—and their relationships with mental and behavioral health. Mindfulness (N Y) 2011;2:179–185. doi: 10.1007/s12671-011-0057-2.
    1. Hill CLM, JA U. Mindfulness and its relationship to emotional regulation. Emotion. 2012;12:81–90. doi: 10.1037/a0026355.
    1. Chiesa A, Malinowski P. Mindfulness-based approaches: are they all the same? J Clin Psychol. 2011;67:404–424. doi: 10.1002/jclp.20776.
    1. Goyal M, Singh S, Sibinga EMS, Gould NF, Rowland-Seymour A, Sharma R, et al. Meditation programs for psychological stress and well-being. JAMA Intern Med. 2014;174:357–368. doi: 10.1001/jamainternmed.2013.13018.
    1. Green SM, Bieling PJ. Expanding the scope of mindfulness-based cognitive therapy: evidence for effectiveness in a heterogeneous psychiatric sample. Cogn Behav Pract. 2012;19:174–180. doi: 10.1016/j.cbpra.2011.02.006.
    1. Hofmann S, Sawyer A, Witt A, Oh D. The effect of mindfulness-based therapy on anxiety and depression: a meta-analytic review. J Consult Clin Psychol. 2010;78:169–183. doi: 10.1037/a0018555.
    1. Alberts HJEM, Mulkens S, Smeets M, Thewissen R. Coping with food cravings. Investigating the potential of a mindfulness-based intervention. Appetite. 2010;55:160–163. doi: 10.1016/j.appet.2010.05.044.
    1. Caldwell K, Baime M, Wolever R. Mindfulness based approaches to obesity and weight loss maintenance. J Ment Health Couns. 2012;34:269–282. doi: 10.17744/mehc.34.3.t016616717774643.
    1. Niemeier HM, Leahey T, Palm Reed K, Brown RA, Wing RR. An acceptance-based behavioral intervention for weight loss: a pilot study. Behav Ther. 2012;43:427–435. doi: 10.1016/j.beth.2011.10.005.
    1. Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, et al. The Mind Your Health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring) 2013;21:1119–1126. doi: 10.1002/oby.20169.

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