Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight
2020年10月13日 更新者：Rhode Island Hospital
Enhancing Emotion Regulation Among Overweight and Obese Adolescents Attempting to Lose Weight
While the prevalence of overweight and obesity among children and adolescents has plateaued, national data indicate that approximately 35% of children and adolescents continue to struggle with overweight/obesity.
While considerable attention has been given to comprehensive behavioral interventions to address obesity in children, there is less empirical evidence demonstrating efficacy of interventions with adolescents.
Additionally, there is great variability and limited impact of adolescent weight control interventions which may be attributable to the failure of these interventions to explicitly address emotion regulation abilities that are necessary for weight loss.
Notably, adolescents with poorer general emotion regulation have been found to consume more snack/junk food and report greater amounts of sedentary behavior.
Poor emotion regulation among adolescents has also been associated with more rapid weight gain and greater BMI.
This project adapts a previously validated Emotion Regulation intervention (TRAC) for at-risk adolescents, targeting sexual risk reduction, to focus on weight loss among a sample of overweight and obese adolescents (ages 12 to 18).
While sexual risk and weight management are distinct health behaviors, this same model of emotion regulation could be applied to overweight/obese adolescents attempting to lose weight.
In fact, data from overweight/obese adolescents attending a past outpatient weight management program (N=124) indicate that 82% of these youth report emotion regulation scores that are comparable to youth with significant mental health problems.
Furthermore, higher levels of emotional dysregulation was associated with greater BMI within this same sample.
These data suggest that emotion regulation is related to health decision making and will be relevant to the majority of overweight/obese adolescents seeking to lose weight.
The current study will be carried out across Phase 1a and 1b.
During Phase 1a, the initial acceptability and feasibility of the adapted intervention (HEALTH TRAC) with eight adolescents in an open pilot trial will be evaluated.
During Phase 1b, 48 adolescents between the ages of 13-17 years will be randomized to receive either the HEALTH TRAC or standard behavioral weight control intervention (SBWC) and examine the impact on emotion regulation abilities and BMI status over an eight-month period.
The information gained in this project will improve understanding of strategies to improve weight loss outcomes among overweight/obsess adolescents and how improving emotion regulation abilities can enhance these interventions.
研究概览
研究类型
介入性
注册 (实际的)
41
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rhode Island
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Providence、Rhode Island、美国、02903
- Coro Building
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
13年 至 17年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 13-17 years of age
- > 85th percentile for BMI but < a BMI of 50
- speak English
- agree to participation and randomization
Exclusion Criteria:
- they are currently in another weight loss program
- have a medical condition that precludes participation in physical activity or adherence to dietary recommendations
- are developmentally delayed such that the intervention will not be appropriate
- are in treatment for a major psychiatric disorder.
- cannot understand English
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：SBWC+ER
Participants randomized to the Standard Behavioral Weight Control and Emotional Regulation (SBWC+ER) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16.
They receive the same information as the Standard Behavioral Weight Control group, but weekly sessions also include elements of TRAC, and it is designed to help teach emotion regulation skills to decrease overeating and sedentary behaviors and increase the likelihood of maintaining diet and exercise behaviors that are taught as part of SBWC interventions.
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Emotion regulation content
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有源比较器：SBWC
Participants randomized to the Standard Behavioral Weight Control (SBWC) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16.
The intervention includes a dietary plan, a fitness plan, behavioral weight control management that includes self-monitoring, goal-setting, stimulus control strategies, and planning, as well as parental involvement.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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BMI decrease
大体时间：baseline, 4 months, and 8 month follow up
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A significant decrease in participant BMI due to weight loss
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baseline, 4 months, and 8 month follow up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Emotion Regulation
大体时间：baseline, 4 month, and 8 month follow up
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Difficulties in Emotion Regulation Scale (DERS)- a 36-item questionnaire designed to assess multiple aspects of emotion regulation (scale: 1 strongly disagree- 5 strongly agree).
Measure yields a total score as well as six scales derived through factor analysis: (1.
Nonacceptance of emotional response, 2. Difficulties engaging in goal directed behavior [goals], 3. Impulse control difficulties [impulse], 4. Lack of emotion awareness [awareness], 5. Limited access to emotion regulation strategies [strategies] 6. Lack of emotional clarity [clarity] ).
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baseline, 4 month, and 8 month follow up
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Emotion Regulation Strategy Usage
大体时间：baseline, 4 month, and 8 month follow up
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Emotion Regulation Behavior Scale (ERBS)- assesses use of emotion regulation strategies taught in intervention.
items include "in the last week, when you were having a strong feeling (e.g., sad, upset, etc.) how often did you...get away from whatever was causing your feeling?..."participants respond on a scale of 1 (never) to 5 (all the time) across 8 items, with higher scores indicating more regulatory behaviors (range: 8-40)
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baseline, 4 month, and 8 month follow up
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Emotion Regulation
大体时间：baseline, 4 month, and 8 month follow up
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Affect Dysregulation Scale (ADS)- 24 item scale adapted from the clinician-rated Affect Regulation and Experience q-sort questionnaire, modified with 6-items used to assess frequency of difficulty with affect regulation on 4-point Likert, with higher scores indicating more difficulty with affect (range: 6-36)
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baseline, 4 month, and 8 month follow up
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Emotion Regulation
大体时间：baseline, 4 month, and 8 month follow up
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Toronto Alexithymia Scale (TAS)- "20 item instrument that is one of the most commonly used measures of alexithymia. Alexithymia refers to people who have trouble identifying and describing emotions and who tend to minimize emotional experience and focus attention externally. 3 subscales: 1-difficulty describing emotions (5 items-2,4,11,12,17), 2- difficulty identifying emotions (7 items-1,3,6,7,9,13,14), and 3- the tendency of individuals to focus their attention externally (8 items-5,8,10,15,16,18,19,20) " (Likert scale: 1 completely disagree - 5 completely agree) (Total range: 20-200) |
baseline, 4 month, and 8 month follow up
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Distress Tolerance
大体时间：baseline and 4 months
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Behavior Indicator of Resiliency to Distress (BIRD)- Manipulation/measure of distress-tolerance.
The first level of the BIRD test lasts 3 minutes.
The level begins with a 5 second latency between dot presentations and changes this latency based on performance (correct answers will reduce the latency by 0.5 seconds whereas incorrect answers or non-responses increase the latency by 0.5 seconds).
At the conclusion of this level an average latency is calculated to index skill level.
The second level lasts five total minutes.
Following a brief rest period the final level begins and lasts for 5 minutes.
At all points in the final level the participant will have an escape option.
The "quit game" on the screen can be clicked at any time.
Therefore making the total time for this game roughly 10-15 minutes long.
(Amstadter et al, 2011)
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baseline and 4 months
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Emotion Regulation
大体时间：baseline, 4 month, and 8 month follow up
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Emotions as a Child scale- "examines parental emotional socialization from both parent and child perspectives across 45-items.
This measure generates 5 subscales of emotion socialization including parental encouragement of emotion expression, parental punishing of responses, parental neglect, parental matching, and parental overriding of child's emotions.
Reliability of subscales range from .80 to .87"
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baseline, 4 month, and 8 month follow up
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Emotion Regulation
大体时间：baseline, 4 month, and 8 month follow up
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Emotion Regulation Checklist (ERC)- "is an instrument for the hetero-evaluation of the level of emotion regulation of children by means of two scales, Emotion Regulation (ER) and Emotional Lability/ Negativity.
24 items that are assessed on a four point Likert scale (1=never, 2=sometimes, 3=often, and 4= almost always).
The ERC comprises two scales: one scale contains 8 items to assess ER, while the other scale contains 15 items that measure emotional liability/negativity, including lack of flexibility, emotional activation, reactivity, anger dysregulation, and mood reliability.
(L/N α = .96;
ER α = .83),
and the two scales are significantly correlated (r = -.50, p < .001).
One single measurement of ER is generated from the overall scores in both sub-scales (α = .89;
Shields & Cicchetti, 1997)."
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baseline, 4 month, and 8 month follow up
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Emotional Eating
大体时间：baseline, 4 month, and 8 month follow up
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Emotional Eating Scale (EES)- "25 item self report measure used to assess the propensity to cope with negative affect by eating.
Subjects rate their desire to eat in response to each emotion on 5 point scale from "1"I have no desire to eat"" through "5"I have a very strong desire to eat""" (Range 25- 125, with higher scores indicating more coping with affect by eating)
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baseline, 4 month, and 8 month follow up
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Eating Disorders
大体时间：baseline, 4 month, and 8 month follow up
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Eating Disorder Examination Questionnaire (EDEQ)- " 28 item questionnaire that has 2 additional questions for males and 5 additional questions for females.
Used to measure eating disorder psychopathology, with higher scores indicating higher eating disorder psychopathy.
Provides a measure of the range and severity of eating disorder features.
Also has the ability to generate operational eating disorder diagnoses.
Used to screen potential participants [Subscales: Restraint (items 1,2,3,4,5), Eating concern (items 7,9,19,20,21), Shape concern (items 6,8,10,11,23,26,27,28), Weight Concern (8,12,22,24,25) ]
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baseline, 4 month, and 8 month follow up
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Eating Habits Confidence
大体时间：baseline to 8 months
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Eating Habits Confidence Questionnaire (EHCQ)- "27-item scale questionnaire asks participants to rate confidence in their ability to adhere to specific dietary behaviors.
Response set consisted of a 5 point-linkert type scale ranging from 1, ""I know I cannot"" to 5, ""I know I can.""
Possible scores of this survey range from 27 to 135, with higher scores indicating higher self-efficacy.
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baseline to 8 months
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Eating Behavior
大体时间：baseline, 4 months, and 8 months
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Eating Behaviors Inventory- "Instrument for assessing behaviors that have been theoretically implicated in weight loss (self monitoring of food intake and of weight, refusing offers of food, eating at only one place, shopping from a list) 30 items are included that are each rate with a 5 point scale according to how often it was true for the respondent.
Items were scored such that the higher scores always reflected more appropriate eating patterns."
(Total range: 30- 150)
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baseline, 4 months, and 8 months
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Accelerometer (physical activity)
大体时间：baseline and 4 months
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Majority of studies say at least 5 days per week for at least 8 hours per day to receive accurate data on PA.
Device used to measure physical activity using criteria such as time spent in activities performed for various intensities and for the prediction of energy expenditure.
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baseline and 4 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Wendy Hadley, PhD、University of Oregon
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年12月1日
初级完成 (实际的)
2019年6月1日
研究完成 (实际的)
2019年7月1日
研究注册日期
首次提交
2017年12月11日
首先提交符合 QC 标准的
2018年1月5日
首次发布 (实际的)
2018年1月8日
研究记录更新
最后更新发布 (实际的)
2020年10月19日
上次提交的符合 QC 标准的更新
2020年10月13日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.