Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
2019년 8월 9일 업데이트: Virginia Commonwealth University
The purpose of this research study is to pilot test a new intervention that helps young adult women learn adaptive eating and exercise strategies, increase their body acceptance, decrease unhealthy weight control behaviors and prevent future eating and problems.
This intervention is experimental, and the study will test its feasibility, acceptability, and effectiveness.
연구 개요
상세 설명
The intervention, Intuitive Eating, is an eating approach that addresses important risk factors and promotes adaptive eating attitudes and behaviors.
It has three central tenets: 1) unconditional permission to eat when hungry, 2) eating for physical rather than emotional reasons, and 3) eating according to hunger and satiety cues.
Intuitive Eating has ten principles that focus on rejecting the dieting mentality, honoring hunger cues, decreasing restrictive behaviors that lead to deprivation and bingeing, challenging rigid food rules, increasing awareness of satiety, discovering the satisfaction of food, coping with emotions without food, respecting and accepting one's body, using exercise as self-care, and balancing nutrition with satisfaction.
연구 유형
중재적
등록 (실제)
71
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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Virginia
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Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:
- Not currently pregnant
- Enrolled in postsecondary education at VCU
- Have body image or eating concerns
Exclusion Criteria:
- Eating disorder threshold risk
- Men
- Pregnant women
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intuitive Eating Group Intervention
Intuitive eating intervention delivered in a group format with 8-10 women, led by 2 facilitators.
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Participants in the group intervention will attend eight weekly, 90-minute sessions involving group activities and discussions.
They will complete homework between sessions to reinforce learning.
The intervention focuses on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
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실험적: Intuitive Eating Guided Self-Help
Participants in this condition engage in 8 weeks of self-study of the intuitive eating intervention have ~20 minute weekly phone call with a study interventionist.
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Participants in the GSH condition will follow the intuitive eating content through self-guided study, with eight weekly scheduled phone calls with an interventionist (~20 minutes each).
Interventionists will review homework assignments, answer questions, and reinforce adherence.
The intervention materials are the same as the group and also focus on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in diagnostic eating disorder symptoms
기간: Baseline to 16 weeks
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The Eating Disorder Diagnostic Scale (EDDS) is a brief self-report measure that screens for the presence of subthreshold or threshold levels of ED symptoms.
It yields a symptom composite score, to be used as the primary outcome measure.
Items assessing body dissatisfaction, overvaluation of shape/weight, and impairment are measured on a 0 to 6-point scale with higher ratings indicating greater body dissatisfaction.
Items evaluating the presence of compensatory behaviors and binge eating are rated yes/no and participants indicate the frequency these behaviors have occurred in the prior 3 months.
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Baseline to 16 weeks
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Change in global eating disorder symptoms
기간: Baseline to 16 weeks
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The EDE-Q is a 28-item self-report version of the Eating Disorder Examination that measures frequency of disordered eating cognitions and behaviors experienced in the previous 28 days.
Participants rate the number of days behaviors have occurred in the last 28 days, with 0 = no days and 6 = every day.
Yes/no questions identify the presence of compensatory and binge behaviors and participants indicate the frequency of these behaviors over the last 28 days.
Higher EDE-Q scores indicate greater eating pathology.
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Baseline to 16 weeks
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Changes in intuitive eating
기간: Baseline to 16 weeks
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The Intuitive Eating Scale-2 (IES-2) is a 23-item self-report measure of intuitive eating with three subscales: Unconditional Permission to Eat, Eating for Physical Rather Than Emotional Reasons, and Reliance on Hunger and Satiety Cues.
Items are rated on a 1 to 5-point scale with higher scores indicating higher levels of intuitive eating.
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Baseline to 16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in body appreciation
기간: Baseline to 16 weeks
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The Body Appreciation Scale-2 (BAS-2) is a 10-item measure of positive body image.
Specifically, it assesses body appreciation, which reflects acceptance of and favorable opinions and respect towards one's body and a rejection of the narrow beauty ideals promoted through mass media.
Items are rated on a 5-point scale with higher scores indicating greater body appreciation.
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Baseline to 16 weeks
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Changes in dietary restraint
기간: Baseline to 16 weeks
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The Dutch Restrained Eating Scale (DRES) contains 10 items that measure dietary restraint for the purpose of weight loss.
Items are rated on a 5-point scale with higher scores reflecting greater dietary restraint.
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Baseline to 16 weeks
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Changes in body functionality appreciation
기간: Baseline to 16 weeks
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The Functionality Appreciation Scale (FAS) is a 7-item scale that measures appreciation for the functionality of one's body, which is believed to help offset appearance concerns.
Items are rated on a 5-point scale with higher scores reflecting greater appreciation for the functionality of one's body.
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Baseline to 16 weeks
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Changes in interoceptive awareness
기간: Baseline to 16 weeks
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The Interoceptive Awareness subscale of the EDI-3 has 10 items that measure an individual's attunement to their internal state, including perceptions of emotions, hunger, and satiety.
Items are rated on a 6-point scale, with higher scores reflecting greater deficits in interoceptive awareness.
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Baseline to 16 weeks
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Changes in intuitive exercise
기간: Baseline to 16 weeks
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The Intuitive Exercise Scale (IEXS) measures adaptive exercise behaviors that are guided by physical cues and flexibility rather than rigid rules or feelings of obligation.
Items are rated on a 5-point scale, with higher scores reflecting more intuitive exercise behaviors.
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Baseline to 16 weeks
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Changes in weight bias internalization
기간: Baseline to 16 weeks
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The Modified Weight Bias Internalization Scale (WBIS-M) is a modified version of the Weight Bias Internalization Scale that was adapted for use with individuals across the weight spectrum.
The WBIS-M measures the degree to which individuals apply weight-based stereotypes to themselves and use those to guide their weight self-evaluations.
Items are rated on a 7-point scale, with higher scores reflecting greater degrees of weight bias internalization.
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Baseline to 16 weeks
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Changes in satisfaction with life
기간: Baseline to 16 weeks
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The Satisfaction with Life Scale (SWLS) is a 5-item scale that assesses global life satisfaction.
Items are scored on a 7-point scale, with higher scores reflecting greater life satisfaction.
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Baseline to 16 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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)
2018년 9월 14일
기본 완료 (실제)
2019년 6월 19일
연구 완료 (실제)
2019년 6월 19일
연구 등록 날짜
최초 제출
2018년 7월 27일
QC 기준을 충족하는 최초 제출
2018년 8월 1일
처음 게시됨 (실제)
2018년 8월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 8월 9일
마지막으로 확인됨
2019년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HM20012263
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
IPD will be available by researcher request only after study completion.
Interested researchers can email the primary study contact.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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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