- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05031611
Intuitive Eating for Disordered Eating (IERCT)
A Web-based Intuitive Eating Intervention for Young Women With Disordered Eating: A Pilot Randomized Controlled Trial
Purpose: Research on intuitive eating is growing, but there are few interventions demonstrating the effect of learning to eat intuitively for people with disordered eating. Young women in particular are at high-risk for developing disordered eating. This study aimed to test the outcomes of a novel intuitive eating intervention for young women with disordered eating.
Methods: This study is the first randomized controlled trial introducing intuitive eating to a sample of participants with disordered eating. Participants with current eating disorders were excluded from this study. Women (n=123) ages 18-30 with high levels of disordered eating participated in this study and were randomized to either a treatment (10-week web-based intervention) or control group (10-week waitlist).
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Bronx, New York, 미국, 10461
- Study was conducted exclusively online
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female
- Between 18 and 30 years of age
- Located in the United States or Canada
- No eating disorder
- No previous participation in an intuitive eating intervention
- Score greater than or equal to 25 on the TFEQ-r18 at baseline
Exclusion Criteria:
- Gender not female
- Younger than 18 years of age
- Older than 30 years of age
- Located outside the United States or Canada
- Score less than 25 on the TFEQ-r18 at baseline
- Previously participated in an intuitive eating intervention
- Current eating disorder
공부 계획
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 Treatment
The intervention was a novel 10-week program aimed at promoting IE through pre-recorded videos, reading material, and bi-weekly discussion sessions. The intervention introduced the following modules sequentially: Unconditional Permission to Eat, Reliance to Hunger and Fullness Cues, Body-Food Choice Congruence, Gentle Nutrition, and Joyful Movement. Every other week, a new module was introduced. Participants were taught the concept of this module through video and reading, then prompted to practice it over the week. On opposite weeks, the module last introduced was discussed in greater detail through video, and participants were given the opportunity to discuss amongst one another and have all questions answered by the researchers. |
Participants received a brief web-based intervention for disordered eating which focused on a style of eating behavior called "intuitive eating".
Please see arm description for more details.
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간섭 없음: Waitlist Control
Waitlist control group participants completed a series of questionnaires at the beginning and end of a 10-week interval, to compare changes in those who completed the intervention versus those who did not.
This group was subsequently invited to participate in the intervention after their time on the wait-list.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intuitive Eating
기간: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Intuitive eating was measured by the Intuitive Eating Scale, 2nd edition (IES-2).
Scores on this scale range from 1 to 5, with higher scores indicating greater levels of Intuitive Eating.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Disordered Eating
기간: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Revised Three Factor Eating Questionnaire (TFEQ-r18)
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Appreciation
기간: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Body appreciation was measured by the Body Appreciation Scale, 2nd edition (BAS-2).
Scores on this scale range from 13 to 65, with higher scores indicating greater levels of body appreciation.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Dichotomous Thinking Around Food
기간: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Dichotomous thinking around food was measured by the Dichotomous Thinking Scale (DT).
Scores on this scale range from 11 to 44, with higher scores indicating greater levels of dichotomous thinking around food.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Psychological Flexibility
기간: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Psychological flexibility was measured by the Acceptance and Action Questionnaire, 2nd edition (AAQ-2).
Scores on this scale range from 7 to 49, with higher scores indicating greater psychological flexibility.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Food Intake
기간: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Food intake was measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data on respondents' food intake.
Participants are asked to recall the frequency in which they consumed various food items over the past 3 days.
Frequencies are grouped by food type (i.e., vegetables, fruits, dairy, etc.) and summed.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Body Mass Index (BMI)
기간: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Weight/Height used to calculate BMI
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20200516
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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