Multidisciplinary Intervention With Cognitive Remediation Therapy for Obese Adults

NCT05295745 | Unknown

• 1 other identifier: CIEB-2019-2-53
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. To evaluate them, psychometric, psychological, physiological, and physical activity tests will be taken.

Conditions

Obesity

Keywords

Adult; obese; Cognitive remediation therapy; multidisciplinary

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

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

  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

  18 weeks with 3 months follow up

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

  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

  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

  18 weeks with 3 months follow up

Study Arms (2)

Cognitive remediation therapy and multidisciplinary intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Cognitive remediation therapy and multidisciplinary intervention BEHAVIORAL

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

Cognitive remediation therapy and multidisciplinary intervention

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Ciudad Juarez: lead

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Loya Yolanda, PhD

  Universidad Autónoma de CIudad Juárez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graciela C Avitia, PhD

CONTACT

6882100; graciela.avitia@uacj.mx

ANA G GARCIA, MA

CONTACT

6882100; al182870@alumnos.uacj.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: March 25, 2022
• Study Start: August 8, 2022
• Primary Completion: November 8, 2022
• Study Completion: May 1, 2023
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: December 2022
• Access Criteria: Cognitive Remediation Therapy adult obesity