The Effects of Food-Specific Inhibitory Control Training on Weight, Diet, and Neural Indices in Overweight and Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Caloric Intake
研究概览
简要总结
Overweight and obese individuals will be randomly assigned to a food-specific or generic inhibitory control training. Food intake, weight, and neural indices of inhibitory control will be assessed prior, immediately after the 4-week intervention, and 12-weeks after intervention completion to assess the effectiveness of a mobile inhibitory control training intervention over time for health outcomes.
详细描述
All participants will report to the lab for a baseline session, where their weight, average food intake for three days (using the Automated Self-Administer 24-hour Dietary Recall [ASA24] system), neural indices of inhibitory control (as assessed by the N2 event-related potential component during a food and genetic go/no-go task), appetitive drive toward food (as measured by the Power of Food Scale) and basic demographic information will be assessed. Based off their gender and baseline levels of inhibitory control (indicated by the N2), participants will be assigned to a four week food-specific inhibitory control training or a generic inhibitory control training. Trainings are administered on a mobile device via an app and participants select four our of five business days to complete the trainings on. Immediately after the four weeks, participants will come in for a follow-up session where their weight, food intake, N2, and appetitive drive to food will be assessed again. Finally, participants will have a 12-week waiting period where they do not complete the trainings. After the 12 weeks, they will come in for a final lab visit where their weight, food intake, N2, and appetitive drive to food will be assessed one last time.
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
Participants are told there is only one intervention for the study and are not aware if they have been assigned to the intervention group or the active control. Research assistants collecting data are blind to what arm the participant was assigned to. During data preprocessing steps, individuals will be blind to what group a participant belongs too (and all data will be preprocessed together). Only when conducting statistical analyses will the principle investigator be aware of what participant belongs to what group, in order to conduct group analyses.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight or Obese (BMI > 25 kg/m2)
排除标准
- •Diagnosis of a psychological disorder (e.g., major depressive disorder, general anxiety disorder), neurological disorder (e.g., epilepsy, stroke), learning disability, or eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
- •Metabolic/chronic disease (e.g., cardiovascular disease, Type II diabetes)
- •Pregnant or lactating
- •Current participation in a weight loss diet
- •Food allergies
- •Head injury that resulted in a loss of consciousness
- •Avid exercisers (i.e., participate in at least 20 minutes of vigorous physical activity more than three times a week)
结局指标
主要结局
Caloric Intake
时间窗: Three days will be completed at baseline, immediately after the intervention, and at the 12 week follow-up visit (total of 9 recalls)
Using the Automated Self-Administered 24-hour Dietary Recall (ASA24), participants will record their food intake for two weekdays and one weekend, two of which will be randomly assigned and one which will be the day they report to their lab visit. Caloric intake, as quantified by ASA24, will be averaged for the three days and statistically analyzed to see if average caloric intake changes over time due to the inhibitory control training arm.
Weight
时间窗: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Weight will be measured in kilograms using a stadiometer to see if weight changes over the course of the study.
N2 Event-Related Potential Component
时间窗: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
The N2 is a negative deflection in the event-related potential waveform occurring 200 to 300 ms after the onset of a stimulus and is larger (i.e., more negative) when an individual has to withhold a dominant response. It is a neural reflection of inhibitory control. The investigators will assess if the N2 amplitude gets larger as a result of inhibitory control training (as individuals will be better at recruiting inhibitory control resources). The investigators will also see if the N2 predicts who is successful at losing weight and reducing caloric intake after the intervention, to better understand the mechanism of action for inhibitory control training.
次要结局
- No-Go Accuracy(Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.)
- Correct Go Reaction Times(Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.)
研究者
Kaylie Carbine
Principal Investigator
Brigham Young University