Multidisciplinary Intervention With Cognitive Remediation Therapy for Obese Adults

March 15, 2022 updated by: Universidad Autonoma de Ciudad Juarez

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive remediation therapy and multidisciplinary intervention
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

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
No Intervention: Control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Baseline and week 18 with 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
Time Frame: Baseline and week 18 with 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
Time Frame: Baseline and week 18 with 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
Time Frame: Baseline and week 18 with 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
Time Frame: Baseline and week 18 with 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
Time Frame: Baseline and week 18 with 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
Time Frame: 18 weeks with 3 months follow-up
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
Time Frame: 18 weeks with 3 months follow up
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
Time Frame: 18 weeks with 3 months follow up
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
Time Frame: 18 weeks with 3 months follow up
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
Time Frame: 18 weeks with 3 months follow up
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
Time Frame: 18 weeks with 3 months follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Ciudad Juarez

Investigators

  • Principal Investigator: Loya Yolanda, PhD, Universidad Autonoma de Ciudad Juarez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 8, 2022

Primary Completion (Anticipated)

November 8, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIEB-2019-2-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Will be published in index journals

IPD Sharing Time Frame

December 2022

IPD Sharing Access Criteria

Cognitive Remediation Therapy adult obesity

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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