Clinical trial NCT05295745: Multidisciplinary Intervention With Cognitive Remediation Therapy for Obese Adults
Official title: Multidisciplinary Intervention and Cognitive Remediation Therapy for Adults With Obesity: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Adult
obese
Cognitive remediation therapy
multidisciplinary
Lead sponsor: Universidad Autonoma de Ciudad Juarez
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in body mass index at week 18 and 3 months follow up
timeFrame: Baseline and week 18 with 3 months follow up
measure: Changes from baseline in waist circumference at week 18 and 3 months follow up
timeFrame: Baseline and week 18 with 3 months follow up
measure: Changes from baseline in body fat at week 18 and 3 months follow up
timeFrame: Baseline and week 18 with 3 months follow up
measure: Changes from baseline in blood chemistry at week 18 and 3 months follow up
timeFrame: Baseline and week 18 with 3 months follow up
measure: Changes from baseline in eating behavior at week 18 and 3 months follow up
timeFrame: Baseline and week 18 with 3 months follow up
measure: Changes from baseline in craving at week 18 and 3 months follow up
timeFrame: Baseline and week 18 with 3 months follow up
measure: Changes from baseline in body image at week 18 and 3 months follow up
timeFrame: Baseline and week 18 with 3 months follow up
Secondary outcomes:
measure: Mental flexibility-changes from baseline in the classification card subscale of the Neuropsychological Battery of Executive Functions and Frontal Lobes
timeFrame: 18 weeks with 3 months follow-up
measure: Inhibitory control-changes from baseline in the Stroop effect subscale of the Neuropsychological Battery of Executive Functions and Frontal Lobes
timeFrame: 18 weeks with 3 months follow up
measure: Working memory-changes from baseline in working memory index scale of the Wechsler Adult Intelligence Scale
timeFrame: 18 weeks with 3 months follow up
measure: Working memory-changes from baseline in self-directed signaling subscale of the Neuropsychological Battery of Executive Functions and Frontal Lobes
timeFrame: 18 weeks with 3 months follow up
measure: Working memory-changes from baseline in ordering of words subscale of the the Neuropsychological Battery of Executive Functions and Frontal Lobes
timeFrame: 18 weeks with 3 months follow up
measure: Processing speed-changes from baseline in processing speed index scale of the Wechsler Adult Intelligence Scale
timeFrame: 18 weeks with 3 months follow up
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autónoma de CIudad Juárez
name: Loya Yolanda, PhD
role: PRINCIPAL_INVESTIGATOR
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