Managing Our Relationship With Food and Eating (NOURISH)
2021年7月30日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
158
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
-
-
Alberta
-
Lethbridge、Alberta、加拿大、T1K 3M4
- University of Lethbridge
-
-
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
18年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
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
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Trauma Informed Yoga
Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.
|
一位在创伤知情瑜伽传授方面接受过培训的持照瑜伽教练将主持在线课程。
将指示参与者在家中的垫子或椅子上上课，或者随着课程的展开在他们之间移动。
讲师将通过介绍本周的主题（例如
接地和安全、不依赖、过去的印记和对我们对 COVID-19 反应的影响、与自然的联系），然后进行呼吸练习（10 分钟）、瑜伽练习（50 分钟）、冥想练习（10分钟）和结束语（10 分钟）。
|
|
实验性的：Trauma Informed Psychotherapy
Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.
|
两名获得许可的辅导员（受过 MSW 培训）将共同促进该计划的在线版本。
主持人将通过介绍本周的主题（例如
在家工作时设定目标、注意、健康应对）（10 分钟），然后进行讲座和活动以整合学习（例如
大型和小型小组讨论使用 Zoom 分组讨论、日记）（70 分钟）和结束语（10 分钟）。
|
|
无干预：Control
These participants will not receive an intervention.
|
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 |
|---|---|---|
|
Changes in Intuitive Eating Behaviours
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Anxiety and Depression
大体时间：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
大体时间：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)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Body Image
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
|
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。
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)
2021年4月1日
初级完成 (实际的)
2021年7月22日
研究完成 (实际的)
2021年7月22日
研究注册日期
首次提交
2021年3月10日
首先提交符合 QC 标准的
2021年3月10日
首次发布 (实际的)
2021年3月15日
研究记录更新
最后更新发布 (实际的)
2021年8月3日
上次提交的符合 QC 标准的更新
2021年7月30日
最后验证
2021年7月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified data relevant to the researcher's research question may be shared upon a reasonable request
IPD 共享时间框架
January 2023, for up to 10 years
IPD 共享访问标准
Researchers must make a reasonable request to the PI
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.