Eating Pace Retraining in Childhood Obesity Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Reduction of eating rate (mouthfuls/min)
研究概览
简要总结
The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace) to help children at risk for obesity (children who eat rapidly and have an overweight parent/legal guardian) develop a more normal eating rate.
详细描述
Childhood obesity is one of nation's foremost public health epidemics, for which more potent and enduring prevention interventions are needed. The goal of this program of research is to study novel methods which may help to prevent childhood obesity. The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - <96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian [ N = 15]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. The investigators hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.
As the sample size is relatively small, the aim is to develop an "effect size estimation," i.e., to generate an effect size that will be used to power an extramural grant application. Specifically, the investigators will generate Cohen's D as the effect size estimate, which is calculated as the difference in the group means divided by the pooled standard deviation. Cohen's D is an established quantitative measure for effect size estimation and informing power analysis for study design.
In addition, this study's objective is to develop and pilot a novel family-based eating behavior program for a prevention intervention in at risk children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 4 to 7 years of age.
- •Participants (the children) have a body mass index (BMI) for age and sex between the 65th-<96th percentile (thus, the children will not have a BMI at the 97th percentile or more).
- •Parental/guardian permission (informed consent).
- •Have an overweight or obese participating parent/guardian with a BMI of > 27 kg/m2
- •Increased child eating rate as reported on the questionnaire (Child Eating Behavior Questionnaire) by the parent/guardian
- •Parent/legal guardian of subject.
- •Age 21 years and above.
- •Have a BMI of > 27 kg/m2.
排除标准
- •Children who have any developmental, medical, or psychiatric condition which might affect study compliance, as described by parental (caregiver) report.
- •Children who have serious medical conditions or use of medications (e.g., chronic oral steroids, antipsychotic medications) known to affect food intake or body weight, as described by parental report.
- •Children who have food allergies which may influence consumption of test foods, as reported by the parent; any child with reported peanut allergy.
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Parents/guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
结局指标
主要结局
Reduction of eating rate (mouthfuls/min)
时间窗: 6 weeks
The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - \<96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian \[ N = 15\]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. We hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.
次要结局
- Reduction of food consumption(6 weeks)