Multidisciplinary Intervention and Cognitive Remediation Therapy for Adults With Obesity: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Changes from baseline in craving at week 18 and 3 months follow up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 19-60
- •BFP >25 (women)
- •BFP >32 (Men)
- •High waist circumference >88 cm (women)
- •High waist circumference >94 cm (men)
- •Signed informed consent
排除标准
- •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
结局指标
主要结局
Changes from baseline in craving at week 18 and 3 months follow up
时间窗: 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.
Changes from baseline in waist circumference at week 18 and 3 months follow up
时间窗: 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.
Changes from baseline in body fat at week 18 and 3 months follow up
时间窗: 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.
Changes from baseline in body mass index at week 18 and 3 months follow up
时间窗: 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
Changes from baseline in blood chemistry at week 18 and 3 months follow up
时间窗: 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.
Changes from baseline in eating behavior at week 18 and 3 months follow up
时间窗: 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.
Changes from baseline in body image at week 18 and 3 months follow up
时间窗: 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
次要结局
- 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)
- 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 ordering of words subscale of the the Neuropsychological Battery of Executive Functions and Frontal Lobes(18 weeks with 3 months follow up)
- 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)
- Processing speed-changes from baseline in processing speed index scale of the Wechsler Adult Intelligence Scale(18 weeks with 3 months follow up)