Multidisciplinary Intervention With Cognitive Remediation Therapy for Obese Adults

Multidisciplinary Intervention and Cognitive Remediation Therapy for Adults With Obesity: Study Protocol for a Randomized Controlled Trial

This study aims to describe the research procedures and treatment of a multidisciplinary intervention with cognitive remediation therapy for adults with obesity in a Randomized Controlled Trial. The changes will be measured before and after the intervention and three months follow-up. To evaluate them, psychometric, psychological, physiological, and physical activity tests will be taken.

A randomized controlled clinical trial will be carried out, implementing a multidisciplinary intervention with cognitive remediation therapy on obese adults from Ciudad Juárez, Chihuahua, México. The efficacy of this therapy has been proved in several countries except México. A randomized controlled trial (RCT) will be executed with both an experimental group and a control group, with repeated measures taken before and after intervention and follow ups of three months. The study will be simple blind and randomization technique will be use to one assign to one of the two conditions. The experimental group will first receive the intervention and once finalized, it will be applied to the control group. The investigator's hypothesis suggests that an intervention of cognitive remediation therapy implemented simultaneously with nutritional education and physical activity improvement in body composition such a body mass index (BMI), waist ratio, body fat, blood chemistry, skin conductance, eating behavior, craving, and body image. An improvement is also expected for the values in the applied psychophysiological tests, the cognitive performance, as well as the eating behavior and physical activities of the participants.

This study has two arms, experimental and control group. The first one will receive the treatment and the control group that does not receive it until the intervention group completes the treatment. Both groups will be measured before and after completion, with three months follow-up

The participants will not be notified about the intervention group or the control group and will be randomly assigned. The procedures of this study will be available only to the researchers, therapists, and the bioethics committee of the Autonomous University of Ciudad Juárez

The participants (obese adults) in the experimental group will receive treatment with cognitive remediation therapy, nutritional and physical activity instruction through 18 weekly sessions of intervention.

The control group participants will not receive the treatment until the experimental group participants complete the intervention and carry out the measurements

The Randomized Controlled Trial will comprise of multidisciplinary intervention and remediation cognitive therapy which will be conducted with obese diagnosed adults of 19-60 years old. The enrolled patients will be randomized in a two-arm control trial with repeated measures and follow-up of three months. The experimental group participants will receive the intervention, while the control group remains on a waiting list. Nutritional and physical activity plus cognitive remediation therapy sessions to improve the thoughts style, problem-solving, planning and organization, the emotions and body image are included

Body Mass Index which will be determined as a participant weight in kg by his eight in meters² (kg/mts²). Basis will be the values set by World Health Organization

Waist ratio will mesure and expressed in centimeters. The individual will be measured in a straight position, from the narrowest part of the trunk, free of clothing, a flexible metric tape will be used, the middle part between the costal flange and the iliac crest serving as a reference point.

Will be recorded and determined through the Seca mBCA 525 body analysis monitor, which includes electronic stadimeter, weighing platform with a 300 kg. capacity, tactile monitor, automatic detection electrode system and electronic system for data recording through the Seca analyticsm BCA 115 software.

To determine the levels for glucose and lipids the CardioCkek PA capilar measurer will be used for it provides fast blood chemistry values and measurements. Basis will be the values set by the Diabetes Latin American Association for Latin American populations which establishes as normal for both glucose and lipids, values larger than or equal to 100 mg/dl establishes as normal for both glucose and lipids, values larger than or equal to 100 mg/dl.

The eating behavior it will established through the 24 hour dietary recall method, recording a normal day's food consumption throughout the day. A format will be used describing the ingredients, type and quantity of food and the hour and location of consumption. This procedure allows learning the quantity of calories consumed and type of macro-nutrients.

The Food Craving Questionnaire-Trait will be used in its Spanish version to measure the intensity with which the desire for eating presents itself. This scale assesses nine subscales: (1) plans and intentions for eating, (2) positive reinforcement anticipation that might result from eating, (3) relief anticipation regarding negative feelings state that result from eating, (4) lack of control over food, (5) thoughts or concerns about food, (6) craving as a physiological state, (7) emotions that might be felt before or during the craving for food or while eating, (8) craving trigger signs for food, (9) sense of guilt because of craving or for giving in to it.

A body form questionnaire will be used, which consists of a 34-item scale that explore the body image's self-perception and allows for the evaluation of both the body image dissatisfaction and the worry for it. This scale has a Cronbach's alpha of .98

Mental flexibility-changes from baseline in the classification card subscale of the Neuropsychological Battery of Executive Functions and Frontal Lobes

The classification card subtest assesses the ability to generate a classification hypothesis and ability of changes criteria (mental flexibility). The score is calculated recording the correct responses and three types of error; normal error, perseverations, deferred perseverations and maintenance errors.

Inhibitory control-changes from baseline in the Stroop effect subscale of the Neuropsychological Battery of Executive Functions and Frontal Lobes

The inhibitory control measurement will be performed using the Stroop effect subscale in his both forms A and B, which evaluates the capability of inhibitory control. In both parts two types of errors and execution time are logged. The types of errors can be made are Stroop and Non-Stroop error.

Working memory-changes from baseline in working memory index scale of the Wechsler Adult Intelligence Scale

The working memory index is a comprised of subtests that assess simultaneous and sequential processing, attention and concentration. Are included two core subtests: digit span, arithmetic and a supplemental subtest, letter-number sequencing, retention of digits, arithmetic and succession of numbers and letters that provide an evaluation of the work memory, measuring the capability to receive information, learn it in the short term and operate with it to achieve an objective.

Working memory-changes from baseline in self-directed signaling subscale of the Neuropsychological Battery of Executive Functions and Frontal Lobes

The subscale to be used will be the one denominated as self-directed signaling which evaluates the capability to use the viso-spatial work memory to point in a self-directed manner a set of figures and no repeat or omit any. The maximum score to achieve in this test is 25.

Working memory-changes from baseline in ordering of words subscale of the the Neuropsychological Battery of Executive Functions and Frontal Lobes

The subscale for alphabetical ordering of words will be used, which calculates the capability to manipulate and mentally order the verbal information contained in the working memory. The score is calculated based on the following aspects: Rehearsal number in which the list is played correctly, perseverance of words that the person repeats more than once, intrusions; words that mention but are not on the list, orders errors, words whose initial vowel or consonant does not correspond, and if the subject does not remember any words in the first trial.

Processing speed-changes from baseline in processing speed index scale of the Wechsler Adult Intelligence Scale

The processing speed index that will be used includes subtest measure the speed and graphomotor processing, includes two core subtests: symbol search and coding, and one supplemental subtest cancellation. Measurement of the processing speed is performed through the fast and correct response ability of those tasks that require observation and discrimination. For this purpose, the subscales denominated as symbols search, codes and cancellation will be used.

Inclusion Criteria: Ages 19-60 BMI >30 BFP >25 (women) BFP >32 (Men) High waist circumference >88 cm (women) High waist circumference >94 cm (men) Signed informed consent Exclusion Criteria: If the participant is enrolled in a weight control or physical exercise program. If the participant is under any medical psychological treatment If the participant is presenting any eating disorder, a thyroid or neurological diseases Pregnant women Unfinished procedures Less than 20% of assistance during the intervention

Smith E, Hay P, Campbell L, Trollor JN. A review of the association between obesity and cognitive function across the lifespan: implications for novel approaches to prevention and treatment. Obes Rev. 2011 Sep;12(9):740-55. doi: 10.1111/j.1467-789X.2011.00920.x. No abstract available.

ALAD (2019). Latin American Diabetes Association. ALAD Guidelines concerning the Diagnosis, Control and Treatment of Type 2 Mellitus Diabetes with Medicine based on Evidence 2019 Edition. Latin American Diabetes Association Magazine ISSN: 2248-6518 México: Permanyer https://www.revistaalad.com/guias/5600AX191_guias_alad_2019.pdf

Allom V, Mullan B, Smith E, Hay P, Raman J. Breaking bad habits by improving executive function in individuals with obesity. BMC Public Health. 2018 Apr 16;18(1):505. doi: 10.1186/s12889-018-5392-y.

Batterink L, Yokum S, Stice E. Body mass correlates inversely with inhibitory control in response to food among adolescent girls: an fMRI study. Neuroimage. 2010 Oct 1;52(4):1696-703. doi: 10.1016/j.neuroimage.2010.05.059. Epub 2010 May 25.

Cabas Hoyos, K., González Bracamonte Y. and Mendoza Álvarez C. (2017). Executive Functioning and Depression in college students with normoweight, overweight and obesity Type 1. Psychological Reports 18 (1) 133-144 https://doi.org/10.18566/infpsic.v18n1a07

Camacho Laraña, M., Alcalá Pérez, V. and Alcalá S.N. (2020). Gender differences in patients with morbid obesity tributary to bariatric surgery. Psychopathology and Clinical Psychology Magazine. ISSN: 1136-5420 doi:10.5944/rppc.vol.20.number.3.2015.15892 Spain: Spanish Association of Clinical Psychology and Psychopathology

Carretero Gomez J, Ena J, Arevalo Lorido JC, Segui Ripoll JM, Carrasco-Sanchez FJ, Gomez-Huelgas R, Perez Soto MI, Delgado Lista J, Perez Martinez P; en representacion del grupo de trabajo de Diabetes, Obesidad y Nutricion de la Sociedad Espanola de Medicina Interna. Obesity is a chronic disease. Positioning statement of the Diabetes, Obesity and Nutrition Workgroup of the Spanish Society of Internal Medicine (SEMI) for an approach centred on individuals with obesity. Rev Clin Esp. 2020 Jul 25:S0014-2565(20)30180-6. doi: 10.1016/j.rce.2020.06.008. Online ahead of print. English, Spanish.

Chao A, Grilo CM, White MA, Sinha R. Food cravings, food intake, and weight status in a community-based sample. Eat Behav. 2014 Aug;15(3):478-82. doi: 10.1016/j.eatbeh.2014.06.003. Epub 2014 Jun 18.

Dohle S, Diel K, Hofmann W. Executive functions and the self-regulation of eating behavior: A review. Appetite. 2018 May 1;124:4-9. doi: 10.1016/j.appet.2017.05.041. Epub 2017 May 25.

Flores Lázaro, J.C., OstroskyShejet, F. and Gutiérrez Loxano, A. (2014). Neuropsychological Development of frontal lobes and executive functions. Editorial/Publisher: The Modern Manual México

Gómez Puente, J.M. y Martínez Marcos, M. (2017). Overweight and Obesity: Efficiency of interventions in adults. Clinical Nursing 28(1) 65-74 ISSN: 1130-8621 Spain: Elsevier https: doi.org/10.1016/j.enfcli.201 7.06.005

González, M. (2018). Role of executive functions in comprehending food intake. Answers or voids? Gastroenterology Venezuelan Society Magazine Vol.72 Númber 2 pages 38-43 ISSN: 2477-975X On line: https://www.researchgate.net/publication/334045971_Rol_de_las_funcion

Guarch Domènech, J. y Navarro Odriozola, V. (2016) Cognitive Psychotherapies. Biological Psychiatry. 23 (S1): 40-45 ISSN: 1134-5934 Spain: Elsevier and Spanish Society of Biological Psychiatry.

Hernández Sampieri, R., Fernández Collado, C., y Baptista Lucio, P. (2014). Methodology of Research. México: Trillas Publisher/Editorial

INSP National Institute of Public Health. Results Report of the National Health and Nutrition Survey (ENSANUT) 2018. México: National Institute of Public Health. On Line: https://ensanut.insp.mx/encuestas/ensanut2018/informes.php

Lafuente, M.D. (2012). Cognitive Behavioral Treatment of Obesity Eating Behavior Disorders (14) 1490-1504 ISSN: 1699-7611 Spain: Behavioral Sciences Institute On Line: https://dialnet.unirioja.es/servlet/articulo?codigo=6250628

Marin-Soto MD, Leon CV, Perez-Vielma NM, Castillo-Ramirez M, Miliar-Garcia A, Murillo-Tovar MM, Mendez-Pena B, Aguilera-Sosa VR. Intense craving for appetizing foods: validation and standardization of the Food Cravings Questionnaire-Trait in Mexico. Gac Med Mex. 2020;156(1):27-33. doi: 10.24875/GMM.19005358.

Meza Peña, C. y Pompa-Guajardo, E.G. (2016). Gender, obesity and self-concept in a teen sample in México. Sports Sciences International Magazine 44 (12) 137-148. ISSN:1885-3137 Spain: Editorial/Publisher Ramón Cantó Alcaraz On Line: http://www.redalyc.org/articulo.oa?id=71044746005

Navarro Santos, F. (2014) Body Image Construction for Overweight Women. Guillén Riebeling, The Modern Manual, A.S. of V.C.

Polo García, D. (2014). Relationship between food anxiety constructos, impulsiveness and sensibility towards the rewards in a college population (master's thesis) Jaén College, Andalucía, Spain.

Raman J, Hay P, Smith E. Manualised Cognitive Remediation Therapy for adult obesity: study protocol for a randomised controlled trial. Trials. 2014 Nov 4;15:426. doi: 10.1186/1745-6215-15-426.

Raman J, Hay P, Tchanturia K, Smith E. A randomised controlled trial of manualized cognitive remediation therapy in adult obesity. Appetite. 2018 Apr 1;123:269-279. doi: 10.1016/j.appet.2017.12.023. Epub 2017 Dec 24.

Ramírez Molina, M.J. (2017). Body Image, body satisfaction, specific auto-efficiencies and risk and health behaviors to improve body image (doctoral thesis). University of Granada, Granada Spain. https://hera.ugr.es/tesisugr/26765640.pdf

Ríos Saldaña, M.R. Rodríguez Soriano, N.Y. and Álvarez Gasca, M.A. (2014). Incidence of Obesity, risks factors and emotional problems in college students. Psychology of Obesity Life Spheres Multidiscipline and complexity 63-74 México: The Modern Manual, A.S of V.C.

Risco, L. y Aros, C. (2019). Mood, nutrition and craving disorders. Chilean Journal of neuropsychiatry. 57 (30) 295-305 ISSN: 0717:9227 Chile: Neurology, Psychiatry and Neurology Society.

Salvador Castell, G., Serra Majem, L. and Ribas Barba, L. (2015). What and how much do we eat? The 24 hour remember method. Spanish Magazine for Community Nutrition 21 (Suppl. 1): 42-44 ISSN: 1135-3074 Spain: Spanish Society for Community Nutrition and Latin american Group for Community Nutrition. Doi10.14642/RENC.2015.21.sup1.5049

Segura, M., Roncero, M., Oltra Cucarella, J., Blasco, L., Ciscar, S., Portillo, M., Malea, A., Espert, R. y Perpiñá, C. (2017). Cognitive remediation Training and emotional abilities in a group format for patients with obesity: A pilot study. Psychopathology and Clinical Psychology Magazine. Vol.22 127-138 doi: 10.5944/rppc

Shama Levy, T., Villalpando-Hernández, S. y Rivera-Dommarco, J. (2006). Procedure's Manual for nutrition projects. Public Health National Institute. On line: http://www.salud.gob.mx/unidades/cdi/documentos/proy_nutricion.pdf

Smith, E., Hay, P. y Raman, J. (2014). Cognitive Remediation Therapy for obesity. En Tchanturia, K. Cognitive Remediation Therapy (CRT) for Eating and Weigth Disorders 176-190 England: Routledge

Sociedad Mexicana de Psicología, Código ético del psicólogo. [Mexican Society of Psychology (2010). Ethical Code for the Psychologist México], Trillas, Ciudad de México, México

Tchanturia, K., Davies, H., Reeder, C. y Wykes, T., (2012). Cognitive Remediation Therapy for Anorexia Nervosa. Translation by López, C., Escobar, T. and Carral, L.

Genders R, Tchanturia K. Cognitive remediation therapy (CRT) for anorexia in group format: a pilot study. Eat Weight Disord. 2010 Dec;15(4):e234-9. doi: 10.1007/BF03325304.

Torres, V., Castro Sánchez, A.M., Matarán Peñarocha, G.A., Lara Palomo, I., Aguilar Fernández, M.E. and Moreno Lorenzo, C. (2011). Benefits of cognitive-behavioral therapy in patients with obesity: randomized clinical trial: Hospital Nutrition (26) 1018-1024 ISSN: 0212-1611 ISSN: 1899-5198 Spain: Spanish Society for Parental and Enteral Nutrition. On Line: http://www.redalyc.org/pdf/3092/309228876015.pdf

Vázquez Arévalo, R., Galán Julio, J., López Aguilar, X., Alvarez Rayón, G.L., Marcilla Díaz, J.M., Caballero Romo, A. and Unikel Santoncini C. (2011). Validity of Body Shape Questionnaire (BSQ) in Mexican Women. Mexican Magazine for Eating Disorders Vol. 2 pages. 45-52 ISSN: 2007-1523 México: Autonomous National University of México

Verdejo-Garcia A, Bechara A. [Neuropsychology of executive functions]. Psicothema. 2010 May;22(2):227-35. Spanish.

WHO World Health Organization. 10 facts about obesity. On Line: https://www.who.int/features/factfiles/obesity/es/, https://www.who.int/es/news- room/fact-sheets/detail/obesity-and-overweight

WHO World Health Organization. GPAQ Analysis Guide On Line: https://www.who.int/ncds/surveillance/steps/resources/GPAQ_Analysis_Guide.pdf