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ObesityNCT05295745

Multidisciplinary Intervention With Cognitive Remediation Therapy for Obese Adults

A study testing Cognitive remediation therapy and multidisciplinary intervention in people with Obesity, run by Universidad Autonoma de Ciudad Juarez.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 60 years
Conditions the study is for
Obesity
What is being tested?
Cognitive remediation therapy and multidisciplinary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
8 Aug 2022to May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Graciela C Avitia, PhD contact

6882100 ext. 3653

graciela.avitia@uacj.mx

ANA G GARCIA, MA contact

6882100 ext. 3688

al182870@alumnos.uacj.mx

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Obesity
Being tested
Cognitive remediation therapy and multidisciplinary intervention
Keywords
Adult, obese, Cognitive remediation therapy, multidisciplinary
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive remediation therapy and multidisciplinary interventionBehavioural

    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

Study groups in NCT05295745
Study groupRoleWhat they receive
Cognitive remediation therapy and multidisciplinary interventionExperimentalThe 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.
Receives: Behavioral: Cognitive remediation therapy and multidisciplinary intervention
ControlNo interventionThe control group participants will not receive the treatment until the experimental group participants complete the intervention and carry out the measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline in body mass index at week 18 and 3 months follow up

    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

    Measured: Baseline and week 18 with 3 months follow up

  2. Changes from baseline in waist circumference at week 18 and 3 months follow up

    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.

    Measured: Baseline and week 18 with 3 months follow up

  3. Changes from baseline in body fat at week 18 and 3 months follow up

    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.

    Measured: Baseline and week 18 with 3 months follow up

  4. Changes from baseline in blood chemistry at week 18 and 3 months follow up

    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.

    Measured: Baseline and week 18 with 3 months follow up

  5. Changes from baseline in eating behavior at week 18 and 3 months follow up

    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.

    Measured: Baseline and week 18 with 3 months follow up

  6. Changes from baseline in craving at week 18 and 3 months follow up

    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.

    Measured: Baseline and week 18 with 3 months follow up

  7. Changes from baseline in body image at week 18 and 3 months follow up

    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

    Measured: Baseline and week 18 with 3 months follow up

Secondary outcomes (6)

  1. 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.

    Measured: 18 weeks with 3 months follow-up

  2. 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.

    Measured: 18 weeks with 3 months follow up

  3. 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.

    Measured: 18 weeks with 3 months follow up

  4. 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.

    Measured: 18 weeks with 3 months follow up

  5. 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.

    Measured: 18 weeks with 3 months follow up

  6. 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.

    Measured: 18 weeks with 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start8 Aug 2022 (estimated)
  3. Primary completion8 Nov 2022 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295745
Sponsor's protocol ID
CIEB-2019-2-53
Status last verified
Mar 2022
First submitted
27 Oct 2021
Last updated
25 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will be published in index journals

Publications

  • 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.

    PubMed 21991597

  • 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.

    PubMed 29661241

  • 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.

    PubMed 20510377

  • 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.

    PubMed 32723530

  • 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.

    PubMed 25064302

  • 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.

    PubMed 28551113

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive remediation therapy and multidisciplinary intervention in people with Obesity, run by Universidad Autonoma de Ciudad Juarez.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Graciela C Avitia, PhD (6882100 ext. 3653, graciela.avitia@uacj.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in body mass index at week 18 and 3 months follow up (time frame: Baseline and week 18 with 3 months follow up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295745, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.

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