Managing Our Relationship With Food and Eating (NOURISH)
2021년 7월 30일 업데이트: Cheryl Currie, University of Lethbridge
There is a need for population-level intervention research to address the impacts of the COVID-19 pandemic on disordered eating and unhealthy eating behaviours.
Systematic reviews have demonstrated that psychotherapy and yoga can help to reduce binge eating and disordered eating habits, however, these interventions were tested in person.
Studies examining the effectiveness of these interventions in an online, group-based format are warranted.
In 2019, the investigators launched a RCT to test gender-stratified group interventions to address mental health and addictive behaviours among community-based adults in southern Alberta.
The investigators implemented this intervention with more than 200 adults in person before this study was paused due to COVID-19; In 2020, the investigators adapted this intervention for online delivery to 200 community-dwelling women across Alberta.
The most recent iteration of this study indicated the participants were particularly concerned about their relationship with food and how they were engaging in different eating behaviours to cope with the stress of COVID-19.
연구 개요
상세 설명
The primary objective of this project is to adapt two existing mental health and substance use interventions and RCT for online delivery to address unhealthy eating behaviours and a negative relationship with food for women within the context of COVID-19.
The second objective is to test if an online group body-oriented intervention (trauma-sensitive yoga) that has been designed to increase awareness of physical sensations, is superior to an online group verbal narrative intervention (mental wellness talking circle), and to control group.
The investigators theorize that the body-oriented intervention may offer the opportunity to reprogram automatic physiologic hyperarousal in response to COVID-19 triggers and increase positive body awareness, and mindful attention to the ways in which habitual self-protective behaviours, like unhealthy eating behaviours, may be impacting health.
The third objective is to examine the impacts of the interventions on adults with pre-existing mental health and disordered eating issues, and those with previous experiences that may make them more susceptible to these problems during COVID-19.
The investigators will track other supports they engage in during the study and the perceived impacts of these supports on their outcomes with the goal of shedding light on how to best match COVID-19 related services to adults who need them the most.
연구 유형
중재적
등록 (실제)
158
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Alberta
-
Lethbridge, Alberta, 캐나다, T1K 3M4
- University of Lethbridge
-
-
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, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:
- Women between 18-75 years living in Alberta, Canada
- Need to have reliable access to the internet, a device with a webcam for the next 2 months
- Need to self-identify that they are currently struggling with at least one of: stress eating, alcohol use, drug use, tobacco use, or gambling during the pandemic
Exclusion Criteria:
- Non-community dwelling
- Not currently residing in Alberta, Canada
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 |
|---|---|
|
실험적: Trauma Informed Yoga
Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.
|
트라우마 정보에 입각한 요가 전달 훈련을 받은 면허가 있는 요가 강사 한 명이 온라인 세션을 이끌 것입니다.
참가자들은 집에 있는 매트나 의자에서 수업에 참여하거나 수업이 진행됨에 따라 그들 사이를 이동하도록 지시받을 것입니다.
강사는 주간 주제(예:
접지 및 안전, 비집착, 과거의 각인 및 COVID-19에 대한 우리의 반응에 미치는 영향, 자연과의 연결), 호흡 연습(10분), 요가 연습(50분), 명상 연습(10분) 분) 및 마무리 단어(10분).
|
|
실험적: Trauma Informed Psychotherapy
Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.
|
2명의 면허 상담사(MSW 훈련)가 이 프로그램의 온라인 버전을 공동 진행합니다.
퍼실리테이터는 이번 주 주제(예:
재택근무 중 목표 설정, 마음챙김, 건강 대처)(10분), 학습 통합을 위한 강의 및 활동(예:
Zoom 소회의실, 일지 작성)(70분) 및 마무리 단어(10분)를 사용한 크고 작은 그룹 토론.
|
|
간섭 없음: Control
These participants will not receive an intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Intuitive Eating Behaviours
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Intuitive eating behaviours will be assessed using the 23-item The Intuitive Eating Scale-2 (IES-2).
Items are measured on a 5-point Likert, with options ranging from "Strongly Disagree" to "Strongly Agree".
Among women, the IES-2 has good internal consistency (α = 0.87), good convergent validity with the original IES (r = 0.87), and strong test-retest reliability (r = 0.88).
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Anxiety and Depression
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Anxiety and depression will be assessed through the 14-item Hospital Anxiety and Depression Scale (HADS).
Seven items assess anxiety while the remaining seven measure depression.
There are four response options (0-3), which create scale values from 0-21 for each scale.
Three ranges of scores have been identified: 0-7 (non-cases), 8-10 (doubtful cases) and 11-21 (cases).
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in addictive eating behaviours
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
To assess addiction-like eating behaviours, questions regarding food cravings, loss of control over food and eating, prioritization of food and eating, and guilty feelings due to food or eating will be measured on a 5-point Likert scale with frequencies ranging from "Never" to "4+ times per week".
Questions regarding concern from others will be measured on a 3-point Likert scale, with the options "Never", "Yes, but not in the past year", and "Yes, in the past year".
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Body Image
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
The 12-item Body Image-Acceptance and Action Questionnaire (BI-AAQ) will be used to assess participants' flexibility with their body image.
The items are measured on a 7-point Likert scale, with options ranging from "Never True" to "Always True".
The BI-AAQ has excellent internal consistency across three samples (α range = 0.92 - 0.93), good test-retest reliability (r = 0.80), and showed divergent validity with body image dissatisfaction (r = -0.80),
dieting (r = -0.70),
food preoccupation (r = -0.61),
and oral control (r = -0.27).
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in Internalized Weight Bias
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Participant experience with weight-based self-stigma will be assessed using 10 items of the 11-item Modified Weight Bias Internalization Scale (WBIS-M).
Items are measured on a 7-point Likert scale with options ranging from "Strongly Disagree" to "Strongly Agree".
The WBIS-M has excellent internal consistency (α = 0.94), and is valid against relevant psychological measures.
The WBIS-M will be administered at all timepoints to assess changes in weight-based self-stigma over the intervention period.
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in Tobacco Use
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Participants will be asked to self-report if tobacco use has changed during the pandemic via a 5-point likert.
Options range from increased a lot to decreased a lot.
If participants indicate their tobacco use has changed, they will be asked to identify the primary reason for this change.
Changes in tobacco use will be re-assessed at each time point.
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in Alcohol Use
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Past year alcohol consumption will be assessed through the Alcohol Use Disorder Identification Test (AUDIT).
Scores on the AUDIT range from 0 to 40; a score over 8 is indicative of problematic or hazardous alcohol use.
Changes in alcohol consumption since the beginning of the pandemic will be identified through a 5-point likert.
Changes in alcohol use will be re-assessed at each time point.
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in Cannabis Use
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Past year cannabis use will be assessed through the Cannabis Use Disorder Identification Test - Revised.
Scores range from 0-31; a score over 8 is indicative of problematic or hazardous use.
Changes in cannabis use will be re-assessed at each time point.
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in Physical Activity and Sedentary Behaviour
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Physical activity will be assessed through the International Physical Activity Questionnaire - Short Form.
The questionnaire asks about frequency and duration of vigorous (VPA) and moderate physical activity (MPA) over the past 7 days.
Weekly Metabolic Equivalents (MET) minutes will be calculated based on responses.
Participants will be categorized into high (>1500 MET min/week with 3+ days of VPA or >3000 METmin/week with 7+ days of MVPA); medium (5+ days of 20+ minutes of VPA per day, 5+ days with 30+ minutes of MPA per day, or 5+ days of MVPA that achieves 600+ MET min/week); low (participant does not meet other cut points).
Frequency and duration of walking and sitting time are also assessed.
The IPAQ has good reliability and criterion validity.
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in Self-Esteem
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Self-esteem will be measured using the 10-item Rosenberg Self Esteem Scale.
The scale is a widely used measure that correlates well with other measures of self-esteem and has strong internal consistency (0.92) and test-retest reliability (0.88).
Scores range from 4 to 40; a higher score indicates higher self esteem.
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
|
Changes in Loneliness
기간: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
Loneliness will be evaluated using a shortened (3 item) version of the UCLA Loneliness Scale.
This scale asks about feelings of companionship, being left out, and being isolated from others in the last month, with a 3-item list of answer options (hardly ever, some of the time, often).
This scale has good reliability (r = 0.73), validity, and internal consistency (Cronbach's α = 0.84-0.94).
The scale also showed convergent validity with other commonly used measures of loneliness.
Scores range from 1 to 9; higher scores indicate higher levels of loneliness.
|
Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
|
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)
2021년 4월 1일
기본 완료 (실제)
2021년 7월 22일
연구 완료 (실제)
2021년 7월 22일
연구 등록 날짜
최초 제출
2021년 3월 10일
QC 기준을 충족하는 최초 제출
2021년 3월 10일
처음 게시됨 (실제)
2021년 3월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 7월 30일
마지막으로 확인됨
2021년 7월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified data relevant to the researcher's research question may be shared upon a reasonable request
IPD 공유 기간
January 2023, for up to 10 years
IPD 공유 액세스 기준
Researchers must make a reasonable request to the PI
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. .
스트레스, 심리적에 대한 임상 시험
-
Goethe UniversityLudwig-Maximilians - University of Munich완전한
-
Istituto Auxologico ItalianoUniversity of Bergen; Catholic University of the Sacred Heart; University of Liege; University... 그리고 다른 협력자들완전한우울증 | 불안 장애 | 스트레스 | 사회적 격리 | Covid-19 Pandemic Psychological 영향이탈리아
트라우마 정보 요가에 대한 임상 시험
-
Istanbul University모집하지 않고 적극적으로
-
University of California, San FranciscoUniversity of California, Davis; University of California, Merced; California Department... 그리고 다른 협력자들완전한
-
University Hospital, Basel, Switzerland완전한
-
University of Zurich모병원발성 폐암 또는 이차성 폐 전이스위스
-
Vanderbilt University Medical Center모집하지 않고 적극적으로
-
Oslo University HospitalAkershus University Hospital, Lørenskog, Norway; Koc University Hospital, Istanbul, Turkey 그리고 다른 협력자들완전한우울증 | 스트레스 | 불명증 | 불안 | 낙천주의 | 대인 관계 이탈 | 전문적인 이행 | 일의 피로 | 자가 보고 의료 오류 | 의사 소진칠면조
-
Stryker Craniomaxillofacial모집하지 않고 적극적으로하악 골절 | 안면 골절 | 상악 골절 | 악교정 수술 절차미국