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临床试验/NCT04624087
NCT04624087已完成不适用

The Effect of Go/No-Go Training Dosage on Weight Loss, Food Evaluation, and Disinhibition in Overweight and Obese Individuals: A Randomized Controlled Trial

University of Minnesota2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
Change in disinhibition scores from baseline to post 4-week intervention, to 6-month follow-up.

研究概览

简要总结

The purpose of this study is to assess the effect of a food-specific Go/No-Go (GNG) computerized training task on weight loss, food evaluation, and disinhibition in a population of overweight and obese individuals.

详细描述

Within the current obesogenic environment, the prevalence of overweight and obesity has dramatically increased over the past 40 years. As a result, approximately 40% of Americans attest to being on a diet, with most of these efforts being unsuccessful. Most weight loss diets rely on self-control and reflective thinking (e.g., making conscious food choices multiple times per day), despite the fact that responses to appetitive foods often occur through implicit (unconscious) processes. The proposed study is a randomized clinical trial for weight loss that targets these implicit processes through the use of a computerized, food-specific, go/no-go task. This task has previously resulted in reduced food consumption in laboratory settings, and small but significant weight loss in two brief intervention studies. The purpose of this study is to replicate one prior study and to compare different doses of the intervention. Participants will be assigned to one of three groups: high intensity, low intensity, or active control, and will be assessed on a number of variables pre- and post-intervention. Changes in body weight, food evaluation, frequency of self-reported food consumption, and eating disinhibition scores will be evaluated. It is hypothesized that individuals receiving the food-specific go/no-go training (high intensity and low intensity groups) will experience greater weight loss, decreased disinhibition with food, and reduced snacking of the targeted foods than those in the active control group. It is also hypothesized that the high intensity intervention will be more effective than the low intensity intervention across these variables. Moderators (e.g., dietary restraint, disinhibition) will also be explored throughout this study, along with the mechanism of devaluation of specific foods.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index (BMI) ≥ 25
  • Consume some of the determined "no-go" snack foods at least three times per week (assessed using a food frequency questionnaire)
  • A desire to lose weight

排除标准

  • Medical condition limiting dietary intake
  • Medical condition directly affecting weight
  • Current use of weight loss medication
  • Actively enrolled in a formal weight loss program currently or within the past 6 months (e.g., Weight Watchers)
  • History of bariatric surgery
  • Currently pregnant
  • Current smoker
  • Smoking cessation within the past year

结局指标

主要结局

Change in disinhibition scores from baseline to post 4-week intervention, to 6-month follow-up.

时间窗: baseline, post 4-week intervention, 6-month follow-up

This will be measured using the Disinhibition subscale of the Three Factor Eating Questionnaire; minimum value = 0; maximum value = 16; higher scores for this measure means worse outcomes

Change in body weight from baseline to post 4-week intervention, to 6-month follow-up

时间窗: baseline, post 4-week intervention, 6-month follow-up

Body weight will be measured by participant using personal or university scale. Participants will take a picture of their weight send it to the research team (Due to COVID-19 precautions, in person weighing is not possible).

Change in frequency of food consumption from baseline to post 4-week intervention, to 6-month follow-up.

时间窗: baseline, post 4-week intervention, 6-month follow-up

This will be measured using a food frequency questionnaire assessing food intake over the previous month.

次要结局

  • Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up.(baseline, post 4-week intervention, 6-month follow-up)
  • Change in liking of foods from baseline to post 4-week intervention, to 6-month(baseline, post 4-week intervention, 6-month follow-up)
  • Change in automatic responses to healthy and unhealthy foods from baseline to post 4-week intervention, to 6-month(baseline, post 4-week intervention, 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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