Program for the Comprehensive Neurocognitive Treatment of Excess Weight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mean change from baseline in Body Mass Index at post-intervention and follow-ups
研究概览
简要总结
The present study aims to determine the effectiveness of a comprehensive neurocognitive program for the treatment of excess weight. The program will include sessions to improve multiple cognitive processes implicated in weight gain and obesity. These cognitive processes include approach-avoidance bias, inhibition control, implementation intentions and episodic future thinking. Participants will be randomly allocated to one of three groups: 1) the experimental group will receive active neurocognitive sessions, 2) an active control group that will receive sham sessions and 3) a usual treatment control group. All three groups will receive a motivational interviewing session, along with personalized diet and physical exercise recommendations. We hypothesized that the neurocognitive program will decrease body mass index in people with overweight and obesity. In addition, the neurocognitive program will improve other anthropometric measures (waist circumference, waist-to-hip and waist-to-height ratios), lifestyle behaviors (eating behavior and physical activity), as well as cognitive processes (approach-avoidance bias, food inhibition, food liking and delay of gratification). Finally, the program will show its efficiency in the economic balance of cost-effectiveness and cost-utility.
详细描述
- STARTING HYPOTHESES AND GENERAL OBJECTIVE HYPOTHESIS: The treatment of excess weight with a comprehensive program based on experimental knowledge about the functioning and modification of the impulsive and executive systems will be effective for the treatment of overweight and obesity. Thus, the neurocognitive training will reduce body mass index (BMI) in people with overweight and obesity, compared to a sham treatment and to only usual treatment. In addition, the neurocognitive program will improve other anthropometric measures (waist circumference, waist-to-hip and waist-to-height ratios), lifestyle behaviors (eating behavior and physical activity), as well as cognitive processes (approach-avoidance bias, food inhibition, food liking and delay of gratification). Finally, the program will show its efficiency in the economic balance of cost-effectiveness and cost-utility.
GENERAL OBJECTIVE: To determine the effectiveness of a comprehensive neurocognitive program for the treatment of excess weight.
1.1. Specific Aims: Objective 1: To examine the effectiveness of a comprehensive neurocognitive training to reduce BMI in the short, medium and long term (post-treatment, 3-month follow-up and 6-month follow-up).
Objective 2: To study the effectiveness of the comprehensive neurocognitive program to change food behaviors, physical activity and body measures.
Objective 3: To investigate which active ingredients have an impact on the results of the program as outlined below:
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
- Double (Participant, Outcomes Assessor)
盲法说明
The psychologists that conduct the assessments (screening, assessment sessions and follow-ups) will be blinded to the group allocation during the whole project. Moreover, since all assessments will be computerized and online, they are not subject to the biases of the evaluator. Further, all participants will be blind to their condition. Also, the people who perform the statistical analyses will be blind to the condition of the groups, through the coding of the interventions. Only the therapist performing the interventions will not be blind to the allocation of the participants.
入排标准
- 年龄范围
- 18 Years 至 55 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 55 years
- •Good command of the Spanish language
- •Have at least two electronic devices available, one of them a smartphone with a gyroscope
排除标准
- •Traumatic, digestive, metabolic or systemic disorders that affect the central nervous system, autonomic or endocrine
- •Cardiovascular or any other disorders that prevent physical exercise
- •Psychopathological disorders or presence of severe symptoms in the Depression Anxiety and Stress Scale-21 (DASS-21)
- •Eating disorders or presence of criteria in the Questionnaire on Eating and Weight Patterns-5 (QEWP-5)
- •Pharmacological or any other kind of treatment for losing weight at present
- •Candidates for bariatric surgery
- •Food conditions that could interfere with the stimulus of the program (allergies, spru, vegetarianism, veganism)
- •Current pregnancy or breastfeeding (or expected pregnancy in the following six months)
- •Weight loss >5% on the 3 months previous to the program
- •Use of medication that affects weight
- •Frequent use of alcohol or other drugs that affects food intake.
结局指标
主要结局
Mean change from baseline in Body Mass Index at post-intervention and follow-ups
时间窗: Through study completion (8 months)
Body mass index (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
- Mean change from baseline in delay of gratification on Now or Later at 1 week(Counterbalanced week 6 or 3 (days 1 and 7))
- Mean change from baseline in the Approach-avoidance bias on the Tilt Task app at 1 week(Counterbalanced week 3 or 6 (days 1 and 7))
- Mean change from baseline in food liking at post-intervention(Baseline (week 1), intermediate assessment (week 5) and post-treatment assessment (week 8))
- Mean change from baseline in food inhibitory control on the Food Training app at 1 week(Counterbalanced week 4 or 7 (days 1 and 7))
- Mean change from baseline in Implementation of Intentions on a self-reported diary at 1 week(Baseline (week 1) and counterbalanced week 7 or 4 (days 1 to 7))
- Mean change from baseline in healthy eating at post-intervention and follow-ups(Weeks 4, 5, 6, 7, 8, 20 and 32)
- Mean change from baseline in adherence to Mediterranean diet at post-intervention(Baseline (week 1) and post-treatment assessment (week 8))
- Mean change from baseline in food choice at post-intervention(Baseline (week 1), intermediate assessment (week 5) and post-treatment assessment (week 8))
- Mean change from baseline in waist-to-height ratio at post-intervention and follow-ups(8 months (at baseline-week 1-, weeks 5, 8, 20 and 32))
- Mean change from baseline on a self-reported 72-hours intake foods at post-intervention and follow-ups(8 months (at baseline-week 1-, weeks 5, 8, 20 and 32))
- Mean change from baseline in exercise habits at post-intervention and follow-ups(Weeks 4, 5, 6, 7, 8, 20 and 32)
- Mean change from baseline in diary footsteps at post-intervention and follow-ups(Through study completion (8 months))
- Mean change from baseline in waist circumference at post-intervention and follow-ups(8 months (at baseline-week 1-, weeks 5, 8, 20 and 32))
- Mean change from baseline in waist-to-hip ratio at post-intervention and follow-ups(8 months (at baseline-week 1-, weeks 5, 8, 20 and 32))
- Mean change from baseline in the IPAQ at post-intervention and follow-ups(8 months (at baseline-week 1-, weeks 5, 8, 20 and 32))
研究者
Raquel Vilar López
Principal Investigator
Universidad de Granada