Effectiveness of a Cognitive Training Therapy for Overweight/Obesity Treatment: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Total weight loss percentage
研究概览
简要总结
This randomized clinical trial was carried out from January 2017 to December 2017 at the facilities of the Catholic University of Murcia. Written informed consent was required from each patient. The protocols of the present clinical trial follow the CONSORT standards. To measure the impact of cognitive training on weight loss in overweight / obese subjects, a double-blind study (de facto masking) was designed.
Both the participants and the statistical assessors were unaware of the study hypothesis. Participants were unaware of treatments and possible assignments between groups, and only those subjects who were randomly assigned to the cognitive training group were informed that such training was part of dietary therapy.
The principal investigator of the present study (J.J.H.M.) carried out the randomization, with the assistance of the Microsoft Excell program, with the help of a macro designed in Visual Basic® for that purpose.
The randomization divided the subjects into two groups, as they were treated with a hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).
In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1 allocation ratio was performed.
Cognitive performance measures were performed before and after training. One week before the beginning of the cognitive and dietary intervention, the participants performed a series of cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were reexamined to measure performance on neurocognitive tests.
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
Randomization was performed by the principal investigator. The interventions were carried out individually, so the participants were unaware of the existence of another study arms.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present a BMI> 27 kg / m2, and want to be part of the study voluntarily
排除标准
- •subjects with diabetes mellitus type 2
- •subjects with a history of a cardiovascular event (acute myocardial infarction, intermittent claudication, etc.)
- •subjects with kidney or liver failure or some other significant pathology (cancer)
- •subjects under pharmacological treatment that could affect body weight (corticoids, thyroxine, etc.)
- •subjects who were on a diet or had been on a diet at least 6 months before their participation in the study were also excluded.
研究组 & 干预措施
Cognitive
The participants of the COGNITIVE group performed cognitive training during 12 sessions during the 3 months of hypocaloric treatment. The training was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.
干预措施: Cognitive Training (Behavioral)
Control
As a control group, we used nutrition education sessions of approximately the same duration (30 min) where we simply reinforced the knowledge that was already provided during the sessions with the patient, such as concepts about the balanced diet, nutrient composition and micronutrients, etc. The objective of this control group was to avoid the effect of time with the researcher.
结局指标
主要结局
Total weight loss percentage
时间窗: 12 weeks
Percentage of weight loss from baseline measurement to the end-of-treatment weight, calculated as (baseline weight - weight at week 12)/baseline weight \* 100
次要结局
未报告次要终点
研究者
Juan Jose Hernández Morante
Professor
Universidad Católica San Antonio de Murcia