Inhibitory Control Training for the Treatment of Excess Weight: Behavioural, Cognitive and Anthropometric Changes (InhibeT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI). Mean change from baseline at post-intervention
研究概览
简要总结
People with excess weight (EW) are characterized by high impulsivity, high levels of craving for high-calorie foods, deficits in inhibitory control, and maladaptive decision-making. The proposed intervention seeks to target these issues. Thus, the present study aims to determine the effectiveness of combining inhibitory control training with usual treatment (diet and physical exercise) in treating people with EW to produce cognitive, behavioral and anthropometric changes. Participants will be randomly allocated to one of two groups: 1) the experimental group that would receive active inhibitory control training and (2) the active control group that will receive placebo inhibitory control training. Both groups will receive individualized diet and physical exercise guidelines. Training requires to inhibit responding to certain foods presented during computerized tasks. Using a food Go/No-Go paradigm, individuals are asked to press a button when a Go cue is presented next to an image and to refrain from pressing a button when a No-Go cue (e.g., a bold frame) is presented. In the experimental group, pictures of healthy and unhealthy foods are always paired with the Go and the No-Go signal, respectively whereas in the control group healthy and unhealthy foods are paired 50% of the time with the Go and 50% with the No-Go signal. It is hypothesized that the experimental intervention would be effective improving (i) Body Mass Index (BMI), (ii) food craving, (iii) anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (iv) eating and physical exercise behaviors (decreased caloric intake and increased frequency and time of physical activity), (v) emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), and (vi) cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making).
详细描述
- HYPOTHESIS: Inhibitory control training with the food Go/NoGo paradigm will be effective in treating people with EW. Thus, the active intervention, compared to the placebo, will achieve: (i) decreased BMI, (ii) decreased craving, (iii) improved anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (iv) improved eating and exercise behaviors (decreased caloric intake increased frequency and time of physical activity), (v) improved emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), (vi) improved cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making).
GENERAL OBJECTIVE: To determine the effectiveness of inhibitory control training for the treatment of people with EW (improvements in BMI, craving, anthropometric measures, food and physical exercise behaviours, emotional symptoms and emotional eating, and cognitive measures). 2. METHODOLOGY
2.1. Design: Randomized controlled trial of parallel groups. The sample size calculation was performed with the G*Power 3.1 tool. To do so, it will be relied on the only study to date that applied food Go/NoGo training (4 sessions in one week) on a median effect size for reducing BMI post-treatment (Cohen's d = 0.57) and at 6-month follow-up (Cohen's d = 0.48). Thus, considering a median effect size for conducting ANOVAs (f= 0.25), the minimum recommended N to reach a power of 0.80, assuming an alpha level of 0.05 with two groups and three repeated measures, was 44 participants, 22 per group. Nevertheless, a conservative approach will be adopted and decided to increase groups to 27 participants.
The participants (N=54) will be randomly allocated to two groups: (i) experimental group (active inhibitory control training); n=27 and (ii) active control group (placebo inhibitory control training); n=27).
2.3. Interventions
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 39.9
- •Age between 18 and 60 years
- •Proficiency in the Spanish language
- •Internet access
- •Computer and smartphone
排除标准
- •Traumatic, digestive, metabolic or systemic disorders that affect the central nervous system, autonomic or endocrine
- •Severe psychopathological disorders, moderate depressive symptoms or treatment for depression
- •Eating disorders
结局指标
主要结局
Body Mass Index (BMI). Mean change from baseline at post-intervention
时间窗: Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)
BMI is a measure of body fat based on height and weight. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m\^2. Height and weight will be obtained with a pharmacy digital weight.
次要结局
- Food Craving. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Waist circumference (WC). Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)])
- Waist-to-hip ratio (WHR). Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)])
- Waist-to-height ratio (WHtR). Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)])
- Eating behaviour. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)])
- Physical activity behaviour. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)])
- Anxiety and Stress. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Depression symptoms. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Non homeostatic eating. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Reward-related eating. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Emotional eating. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Emotion Regulation Strategies. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Motor inhibition. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Cognitive inhibition. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Delay of gratification. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Inhibition and activation systems. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Self-reported impulsivity. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Working Memory. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Cognitive flexibility. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Decision making. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
研究者
Raquel Vilar López
Principal Investigator
Universidad de Granada