Clinical trial NCT02893150: Mindfulness Intervention for Overweight Primary Care Patients
Official title: Mindfulness as a Complementary Intervention for Overweight Primary Care Patients: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Mindful Eating
Overweight
Primary Care
Randomized Clinical Trial
Lead sponsor: Centro Mente Aberta de Mindfulness
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-09-08
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Mindfulness has been applied in the United States and Europe to improve both physical and psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its lack, may also have particular relevance to obesity and eating disorders, reducing the episodes of "binge eating", which are partly responsible for weight regain for many people, and improving the eating behavior in order to promote awareness of emotional states which distort the physiological signals generated by the process. The hypothesis is that Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a sustainable fashion, improve biochemical, psychometric and anthropometric parameters in primary care patients with overweight.

Detailed description: A randomized-controlled trial will be conducted to compare treatment-as-usual (TAU) in Primary Care combined a generic MBI (with 8 sessions) developed by our research group, called "Mindfulness-Based Health Promotion" (MBHP) program versus TAU plus MB-EAT. It will be included women aged ≥18 and \< 60, literate , with a BMI (body mass index) ≥ 25 kg/m2. The primary outcome is the improvement of the eating behaviour measured by DEBQ. Secondary outcomes are: It is expected improvement of nutritional status (reduction of body weight by at least 5% of the weight) along the intervention, as well as maintenance of this (without weight regain) which could lead to the prevention of multiple morbidities related to excess body weight. Will be assessed the levels of Mindfulness, stress, anxiety (psychometric scale and serum cortisol) and self-compassion. There will be performed basal (baseline), at post-intervention, 3 and 6 months follow-up measurements. The control group will receive the intervention that has been shown to be more effective at the end of the study (MBHP or MB-EAT).

Eligibility criteria: Inclusion Criteria:

* women aged 18-59 years old, literate;
* Primary Care patients who have the body mass index (BMI) ≥25kgm2 and \< 40kg/m2
* People who have an interest in the objectives of this study and consented to be randomized to one of three arms.
* Those who have participated in 75% of sessions or only two absences in the program

Exclusion Criteria:

* those who are under pharmacological treatment for overweight;
* pregnant women;
* those who have problems with substance use (drugs and alcohol);
* untreated hypothyroidism or hyperthyroidism;
* those who are in acute phase of depression (less than 6 months in depression); schizophrenia or psychotic disorders or who are using drugs that cause cognitive attentional and concentration losses (such as powerful anti-anxiety drugs);
* current practitioners of Mindfulness, meditation, yoga, or the like, in the last 6 months (with formal practice at least once a week);
* those who have undergone any type of Bariatric Surgery.

Primary outcomes:
measure: Feeding Behaviour
timeFrame: Up to 3-month of follow-up
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: Up to 3-month of follow-up
measure: levels of mindfulness,
timeFrame: Up to 3-month of follow-up
measure: Levels of depression
timeFrame: Up to 3-month of follow-up
measure: Levels of anxiety
timeFrame: Up to 3-month of follow-up
measure: Serum cortisol
timeFrame: Up to 3-month of follow-up
measure: Self-compassion
timeFrame: Up to 3-month of follow-up
measure: HBA1C (glycated hemoglobina)
timeFrame: Up to 3-month of follow-up
measure: Insulin
timeFrame: Up to 3-month of follow-up
Other outcomes:
measure: Cholesterol and fractions, triglycerides
timeFrame: Up to 3-month of follow-up
measure: C-reactive protein
timeFrame: Up to 3-month of follow-up
measure: waist perimeter
timeFrame: Up to 3-month of follow-up
measure: food consumption
timeFrame: Up to 3-month of follow-up
measure: Body fat
timeFrame: Up to 3-month of follow-up
measure: Basal metabolism rate
timeFrame: Up to 3-month of follow-up
measure: Physical Activity
timeFrame: Up to 3-month of follow-up
measure: Risk of eating Disorder
timeFrame: Up to 3-month of follow-up
Locations:
city: São Paulo
country: Brazil
facility: Centro Mente Aberta de Mindfulness e Promoção de Saúde
state: SP
Study officials:
affiliation: UNIFESP - Federal University of Sao Paulo, Brazil
name: Marcelo Demarzo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Estratégias para o cuidado da pessoa com doença crônica : obesidade / Ministério da Saúde, Secretaria de Atenção à Saúde, Departamento de Atenção Básica. - Brasília : Ministério da Saúde, 2014. 212 p. : il. - (Cadernos de Atenção Básica, n. 38)- Academy of Nutrition and Dietetics. Weight Management Matters, 7 (4), Spring; 2010
citation: IBGE. Pesquisa de Orçamentos Familiares 2008-2009: análise do consumo alimentar pessoal no Brasil. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística, 2011
citation: Moura EC, Silva SA, Malta DC, Morais Neto OL. [Risk and protective factors for chronic non-communicable diseases: the VIGITEL telephone disease surveillance system, Brazil, 2007]. Cad Saude Publica. 2011 Mar;27(3):486-96. doi: 10.1590/s0102-311x2011000300009. Portuguese.
citation: ______. Pesquisa de Orçamentos Familiares 2008-2009: análise do consumo alimentar pessoal no Brasil. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística, 2011.
citation: Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.
citation: Glanz K. Review of nutritional attitudes and counseling practices of primary care physicians. Am J Clin Nutr. 1997 Jun;65(6 Suppl):2016S-2019S. doi: 10.1093/ajcn/65.6.2016S.
citation: De Nooijer J, Van Assema P, De Vet E, Brug J. How stable are stages of change for nutrition behaviors in the Netherlands? Health Promot Int. 2005 Mar;20(1):27-32. doi: 10.1093/heapro/dah504. Epub 2005 Jan 24.
citation: Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
citation: Byrne S, Cooper Z, Fairburn C. Weight maintenance and relapse in obesity: a qualitative study. Int J Obes Relat Metab Disord. 2003 Aug;27(8):955-62. doi: 10.1038/sj.ijo.0802305.
citation: Gusmão, J. L. et al. Adesão ao tratamento em hipertensão arterial sistólica isolada. Revista Brasileira de Hipertensão. 2009. 16(1): p. 38-43.
citation: Santos, A. C. A inserção do nutricionista na estratégia da saúde da família: o olhar de diferentes trabalhadores da saúde. Fam. Saúde Desenv. 2005.7(3): p.257-265.
citation: Oliveira DC, Sa CP, Gomes AM, Ramos Rde S, Pereira NA, Santos WC. [Brazilian National Health Policy: health professionals' social representations]. Cad Saude Publica. 2008 Jan;24(1):197-206. doi: 10.1590/s0102-311x2008000100020. Portuguese.
citation: ______. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Política Nacional de Atenção Básica. Brasília: Ministério da Saúde, 2006f. (Série A. Normas e Manuais Técnicos), (Série Pactos pela Saúde, v. 4).
citation: Demarzo MMP. Mindfulness e Promoção da Saúde. RESC. 2015. 2(3): e82.
citation: Keng SL, Smoski MJ, Robins CJ. Effects of mindfulness on psychological health: a review of empirical studies. Clin Psychol Rev. 2011 Aug;31(6):1041-56. doi: 10.1016/j.cpr.2011.04.006. Epub 2011 May 13.
citation: Camilleri GM, Mejean C, Bellisle F, Hercberg S, Peneau S. Association between Mindfulness and Weight Status in a General Population from the NutriNet-Sante Study. PLoS One. 2015 Jun 3;10(6):e0127447. doi: 10.1371/journal.pone.0127447. eCollection 2015.
citation: Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
citation: Demarzo MMP. Meditação aplicada à saúde. Programa Atualização em Med Família e Comunidade. 6th ed. Porto Alegre-RS: Artmed. 2011. 6(1): p.1-18.
citation: Monshat K, Castle DJ. Mindfulness training: an adjunctive role in the management of chronic illness? Med J Aust. 2012 May 21;196(9):569-71. doi: 10.5694/mja11.10974.
citation: Berg, Raquel. Uma análise freudiana da obesidade- Dissertação de Mestrado- programa de Pós-graduação em Psicologia da Universidade de São Paulo, 2008 136p.
citation: Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
citation: Kaliman P, Alvarez-Lopez MJ, Cosin-Tomas M, Rosenkranz MA, Lutz A, Davidson RJ. Rapid changes in histone deacetylases and inflammatory gene expression in expert meditators. Psychoneuroendocrinology. 2014 Feb;40:96-107. doi: 10.1016/j.psyneuen.2013.11.004. Epub 2013 Nov 15.
citation: Schutte NS, Malouff JM. A meta-analytic review of the effects of mindfulness meditation on telomerase activity. Psychoneuroendocrinology. 2014 Apr;42:45-8. doi: 10.1016/j.psyneuen.2013.12.017. Epub 2014 Jan 7.
citation: Daubenmier J, Kristeller J, Hecht FM, Maninger N, Kuwata M, Jhaveri K, Lustig RH, Kemeny M, Karan L, Epel E. 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. Epub 2011 Oct 2.
citation: Dalen J, Smith BW, Shelley BM, Sloan AL, Leahigh L, Begay D. Pilot study: Mindful Eating and Living (MEAL): weight, eating behavior, and psychological outcomes associated with a mindfulness-based intervention for people with obesity. Complement Ther Med. 2010 Dec;18(6):260-4. doi: 10.1016/j.ctim.2010.09.008. Epub 2010 Nov 11.
citation: O'Reilly GA, Cook L, Spruijt-Metz D, Black DS. Mindfulness-based interventions for obesity-related eating behaviours: a literature review. Obes Rev. 2014 Jun;15(6):453-61. doi: 10.1111/obr.12156. Epub 2014 Mar 18.
citation: Godfrey KM, Gallo LC, Afari N. Mindfulness-based interventions for binge eating: a systematic review and meta-analysis. J Behav Med. 2015 Apr;38(2):348-62. doi: 10.1007/s10865-014-9610-5. Epub 2014 Nov 23.
citation: Satter E. Eating competence: definition and evidence for the Satter Eating Competence model. J Nutr Educ Behav. 2007 Sep-Oct;39(5 Suppl):S142-53. doi: 10.1016/j.jneb.2007.01.006.
citation: Mantzios M, Wilson JC. Mindfulness, Eating Behaviours, and Obesity: A Review and Reflection on Current Findings. Curr Obes Rep. 2015 Mar;4(1):141-6. doi: 10.1007/s13679-014-0131-x.
citation: Olson KL, Emery CF. Mindfulness and weight loss: a systematic review. Psychosom Med. 2015 Jan;77(1):59-67. doi: 10.1097/PSY.0000000000000127.
citation: 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 Apr;15(2):197-204. doi: 10.1016/j.eatbeh.2014.01.005. Epub 2014 Feb 1.
citation: Academy of Nutrition and Dietetics. Weight Management Matters, 7 (4), Spring; 2010
citation: Kristeller JL, Wolever RQ. Mindfulness-based eating awareness training for treating binge eating disorder: the conceptual foundation. Eat Disord. 2011 Jan-Feb;19(1):49-61. doi: 10.1080/10640266.2011.533605.
citation: Kristeller, J. L. Mindfulness, wisdom and eating: Applying a multi-domain model of meditation effects. Journal of Constructivism in the Human Sciences, 2003. 8: p. 107-118.
citation: 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 Sep;2(3):179-185. doi: 10.1007/s12671-011-0057-2.
citation: Hill CL, Updegraff JA. Mindfulness and its relationship to emotional regulation. Emotion. 2012 Feb;12(1):81-90. doi: 10.1037/a0026355. Epub 2011 Dec 12.
citation: Chiesa A, Malinowski P. Mindfulness-based approaches: are they all the same? J Clin Psychol. 2011 Apr;67(4):404-24. doi: 10.1002/jclp.20776. Epub 2011 Jan 19.
citation: Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
citation: Green, S. M., & Bieling, P. J. Expanding the scope of mindfulness-based cognitive therapy: Evidence for effectiveness in a heterogeneous psychiatric sample. Cognitive and Behavioral Practice, 2012. 19(1): p.174- 180.
citation: Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
citation: Alberts HJ, Mulkens S, Smeets M, Thewissen R. Coping with food cravings. Investigating the potential of a mindfulness-based intervention. Appetite. 2010 Aug;55(1):160-3. doi: 10.1016/j.appet.2010.05.044. Epub 2010 May 21.
citation: Caldwell K, Baime M, Wolever R. Mindfulness based approaches to obesity and weight loss maintenance. J Men Health Couns, 2012. 34: p.269.
citation: 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 Jun;43(2):427-35. doi: 10.1016/j.beth.2011.10.005. Epub 2011 Dec 1.
citation: Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring). 2013 Jun;21(6):1119-26. doi: 10.1002/oby.20169. Epub 2013 May 13.
citation: Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
citation: Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
citation: Cordás TA, Neves JEP. Escalas de avaliação de transtornos alimentares. Rev Psiq Clin. 1999, 26: p. 41-8.
citation: Cordás TA, Hochgraf PO. "BITE": instrumento para avaliação da bulimia nervosa - versão português. J Bras Psiquiatr ,1993. 42: p.141-4.
citation: Castro M, Moreira AC. Análise Crítica do Cortisol Salivar na Avaliação do Eixo Hipotálamo-Hipófise-Adrenal. Arq Bras Endocrinol Metab, 2003.7(4):p. 358-367.
citation: Raff H. Salivary cortisol: a useful measurement in the diagnosis of Cushing's syndrome and the evaluation of the hypothalamic-pituitary-adrenal axis. The Endocrinologist, 2000. 10: p. 9-17.
citation: de Salvo VL, Gimeno SG. [Reproducibility and validity of a food frequency questionnaire]. Rev Saude Publica. 2002 Aug;36(4):505-12. doi: 10.1590/s0034-89102002000400018. Portuguese.
citation: Duarte, A. C. et al. Síndrome metabólica: semiologia, bioquímica e prescrição nutricional. Rio de Janeiro: Axcel Books do Brasil, 2005.
citation: Faria SL, Faria OP, Cardeal MD, Ito MK. Validation study of multi-frequency bioelectrical impedance with dual-energy X-ray absorptiometry among obese patients. Obes Surg. 2014 Sep;24(9):1476-80. doi: 10.1007/s11695-014-1190-5.
citation: Rodrigues AE, Marostegan PF, Mancini MC, Dalcanale L, Melo ME, Cercato C, Halpern A. [Analysis of resting metabolic rate evaluated by indirect calorimetry in obese women with low and high caloric intake]. Arq Bras Endocrinol Metabol. 2008 Feb;52(1):76-84. doi: 10.1590/s0004-27302008000100011. Portuguese.
citation: Melo CM, Tirapegui J, Ribeiro SM. [Human energetic expenditure: concepts, assessment methods and relationship to obesity]. Arq Bras Endocrinol Metabol. 2008 Apr;52(3):452-64. doi: 10.1590/s0004-27302008000300005. Portuguese.
citation: Barros, V. V., E. H. Kozasa, I. C. W. Souza and T. M. Ronzani .
citation: Neff, K. The development and validation of a scale to measure self-compassion. Self and Identity, 2003a. 2: p. 85-101.
citation: Neff, K. Self-Compassion: An Alternative Conceptualization of a Healthy Attitude Toward Oneself. Self and Identity, 2003. 2: p. 85-101.
citation: Neff, K. Self-compassion and adaptive psychological functioning. Journal of Research in Personality, 2007. 41: p. 139-154.
citation: Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.
citation: BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
citation: Cunha, J. A. Manual da versão em português das Escalas Beck. São Paulo: Casa do Psicólogo, 2001.
citation: Queiroz DT, Vall J, Souza AMA, Vieira NFC. Observação participante na pesquisa qualitativa: conceitos e aplicações na área da saúde. R Enferm UERJ, 2007.15(2): p.276-83.
citation: Kerrigan D, Johnson K, Stewart M, Magyari T, Hutton N, Ellen JM, Sibinga EM. Perceptions, experiences, and shifts in perspective occurring among urban youth participating in a mindfulness-based stress reduction program. Complement Ther Clin Pract. 2011 May;17(2):96-101. doi: 10.1016/j.ctcp.2010.08.003. Epub 2010 Sep 16.
citation: Nakamura E. O Método Etnográfico em Pesquisas na Área da Saúde: uma reflexão antropológica Saúde Soc. São Paulo, 2011. 20(1): p.95-103.
citation: Sociedade Brasileira de Endocrinologia e Metabologia- Projeto Diretrizes - Obesidade: Terapia Cognitivo-Comportamental, 2005 10p.
citation: Salvo V, Schveitzer MC, Sanudo A, Favarato ML, Demarzo M. Exploring perceptions about Mindfulness and Mindful Eating Programs for low-income women with overweight in primary health care. Nutr Health. 2023 Jun;29(2):319-329. doi: 10.1177/02601060221075537. Epub 2022 Feb 9.
citation: Salvo V, Kristeller J, Montero Marin J, Sanudo A, Lourenco BH, Schveitzer MC, D'Almeida V, Morillo H, Gimeno SGA, Garcia-Campayo J, Demarzo M. Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial. Trials. 2018 May 11;19(1):277. doi: 10.1186/s13063-018-2639-y.