Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight
2020년 10월 13일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
41
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Coro Building
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
13년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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BMI decrease
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Emotion Regulation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Wendy Hadley, PhD, University of Oregon
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 12월 1일
기본 완료 (실제)
2019년 6월 1일
연구 완료 (실제)
2019년 7월 1일
연구 등록 날짜
최초 제출
2017년 12월 11일
QC 기준을 충족하는 최초 제출
2018년 1월 5일
처음 게시됨 (실제)
2018년 1월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 10월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 10월 13일
마지막으로 확인됨
2019년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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