Multidisciplinary Intervention With Cognitive Remediation Therapy for Obese Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Cognitive remediation therapy and multidisciplinary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive remediation therapy and multidisciplinary intervention<br>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. | Behavioral: Cognitive remediation therapy and multidisciplinary intervention<br>* 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<br>|
| No Intervention: Control<br>The control group participants will not receive the treatment until the experimental group participants complete the intervention and carry out the measurements | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and week 18 with 3 months follow up | 
| 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. | Baseline and week 18 with 3 months follow up | 
| 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. | Baseline and week 18 with 3 months follow up | 
| 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. | Baseline and week 18 with 3 months follow up | 
| 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. | Baseline and week 18 with 3 months follow up | 
| 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. | Baseline and week 18 with 3 months follow up | 
| 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 | Baseline and week 18 with 3 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 weeks with 3 months follow-up | 
| 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. | 18 weeks with 3 months follow up | 
| 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. | 18 weeks with 3 months follow up | 
| 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. | 18 weeks with 3 months follow up | 
| 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. | 18 weeks with 3 months follow up | 
| 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. | 18 weeks with 3 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, obese, Cognitive remediation therapy, multidisciplinary