The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in zBMI
研究概览
简要总结
This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.
详细描述
The study will be mostly observational but will also include a randomized, cross-over design (the restricted access paradigm). The investigators will recruit children at risk for obesity in Erie County, New York (N=100, 50 boys, 50 girls). The study will include 4 visits at baseline and follow-up visits at 6 and 12 months. At the first visit, the participants will complete consent, height/weight/body fat, questionnaires, and complete a delayed discount task and the relative reinforcing value task. The participants will be randomized to have two weeks of restricted access first or two weeks of non-restricted access first, and then will come into the laboratory to do the loss of control test meal. Then they will have a one-week washout period, and will then complete the other two weeks of restricted/not restricted access. Following this, they will complete the loss of control test meal again. At the follow-up visits, participants will come into the laboratory to have their height/weight/body fat measured, complete questionnaires, and complete the delayed discounting task, food reinforcement and loss of control test meals. Participants will be compensated for their time after each visit. The details of the measures and procedures are outlined below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children (male and female) ages 8-11
- •At risk for obesity or with obesity (defined as either having a BMI percentile that classifies the child as having overweight-BMI >85th percentile but <99th OR one + biological parent with overweight/obesity-BMI >25)
- •Rating of neutral or higher for 50% of the study foods
- •Consumption of one of the study foods at least twice/week
排除标准
- •Children below age 8 or above age 11
- •Not at risk for obesity (defined as having a BMI percentile that classifies the child as having normal weight-BMI <85th percentile without having a parent with overweight or obesity)
- •Allergic to study foods
- •Dislike of study foods (Less than 50% of the study foods rated neutral or higher)
- •Does not consume at least one study food at least twice/week
- •Current diagnosis of a clinical eating disorder (ED)
- •Use of medications known to affect appetite (Ritalin, Adderall, Concerta, Wellbutrin, Prednisone, etc)
- •Unwillingness to complete study visits
研究组 & 干预措施
Behavioral restriction
In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. In the structured intake period period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period.
干预措施: Restricted access task (Behavioral)
结局指标
主要结局
Change in zBMI
时间窗: Baseline to 12 months
Change in zBMI from baseline to 12 month follow-up
次要结局
- Change in body fat percentage(Baseline to 12 months)
- Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating.(Baseline)
- Association between relative reinforcing value of high energy dense foods and LOC(Baseline)
- Relationship between self-reported LOC eating and consumption during LOC test meal(Baseline)
研究者
Katherine Balantekin
Principal Investigator
State University of New York at Buffalo