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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
158
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alberta
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Lethbridge、Alberta、カナダ、T1K 3M4
- University of Lethbridge
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Trauma Informed Yoga
Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.
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トラウマインフォームドヨガのトレーニングを受けた有資格のヨガインストラクター1名がオンラインセッションをリードします。
参加者は、自宅のマットまたは椅子からクラスに参加するか、クラスが展開するにつれてそれらの間を移動するように指示されます.
インストラクターは、その週のテーマを紹介することからクラスを開始します (例:
グラウンディングと安全、無執着、過去の痕跡とCOVID-19への反応への影響、自然とのつながり）、呼吸の練習（10分）、ヨガの練習（50分）、瞑想の練習（10分）分) と締めくくりの言葉 (10 分)。
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実験的：Trauma Informed Psychotherapy
Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.
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ライセンスを取得した 2 人のカウンセラー (MSW のトレーニングを受けた) が、このプログラムのオンライン バージョンを共同で推進します。
ファシリテーターは、その週のテーマを紹介することからセッションを開始します (例:
在宅勤務中に目標を設定し、注意を払い、健康に対処する）（10分）、その後、学習を統合するための講義と活動が続きます（例：
Zoom ブレイクアウト ルームを使用した大小のグループ ディスカッション、ジャーナリング) (70 分)、および結びの言葉 (10 分)。
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介入なし：Control
These participants will not receive an intervention.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Intuitive Eating Behaviours
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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).
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Anxiety and Depression
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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).
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in addictive eating behaviours
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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".
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Body Image
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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).
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Internalized Weight Bias
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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.
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Tobacco Use
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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.
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Alcohol Use
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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.
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Cannabis Use
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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.
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Physical Activity and Sedentary Behaviour
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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.
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Self-Esteem
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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.
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Loneliness
時間枠：Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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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.
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年4月1日
一次修了 (実際)
2021年7月22日
研究の完了 (実際)
2021年7月22日
試験登録日
最初に提出
2021年3月10日
QC基準を満たした最初の提出物
2021年3月10日
最初の投稿 (実際)
2021年3月15日
学習記録の更新
投稿された最後の更新 (実際)
2021年8月3日
QC基準を満たした最後の更新が送信されました
2021年7月30日
最終確認日
2021年7月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified data relevant to the researcher's research question may be shared upon a reasonable request
IPD 共有時間枠
January 2023, for up to 10 years
IPD 共有アクセス基準
Researchers must make a reasonable request to the PI
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いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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