Managing Our Relationship With Food and Eating (NOURISH)
30 juillet 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
158
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alberta
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Lethbridge, Alberta, Canada, T1K 3M4
- University of Lethbridge
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Trauma Informed Yoga
Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.
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Un instructeur de yoga agréé, formé à la prestation de yoga tenant compte des traumatismes, dirigera les séances en ligne.
Les participants seront invités à participer au cours depuis un tapis ou une chaise dans leur maison ou à se déplacer entre eux au fur et à mesure du déroulement du cours.
L'instructeur commencera le cours en introduisant le thème de la semaine (par ex.
ancrage et sécurité, détachement, empreintes du passé et impacts sur nos réactions au COVID-19, connexion à la nature), suivies d'une pratique de respiration (10 min), d'une pratique de yoga (50 min), d'une pratique de méditation (10 min) et mots de clôture (10 min).
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Expérimental: Trauma Informed Psychotherapy
Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.
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Deux conseillers agréés (formés par MSW) co-animeront la version en ligne de ce programme.
Les animateurs commenceront la session en présentant le thème de la semaine (par ex.
fixer des objectifs tout en travaillant à domicile, être conscient, faire face à la santé) (10 min), suivi d'une conférence et d'une activité pour intégrer l'apprentissage (par ex.
discussion en petits et grands groupes à l'aide de salles de sous-commissions Zoom, journalisation) (70 min) et mots de clôture (10 min).
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Aucune intervention: Control
These participants will not receive an intervention.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Intuitive Eating Behaviours
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Anxiety and Depression
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Body Image
Délai: 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).
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Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
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Changes in Internalized Weight Bias
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2021
Achèvement primaire (Réel)
22 juillet 2021
Achèvement de l'étude (Réel)
22 juillet 2021
Dates d'inscription aux études
Première soumission
10 mars 2021
Première soumission répondant aux critères de contrôle qualité
10 mars 2021
Première publication (Réel)
15 mars 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 août 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 juillet 2021
Dernière vérification
1 juillet 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021 - 020
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
De-identified data relevant to the researcher's research question may be shared upon a reasonable request
Délai de partage IPD
January 2023, for up to 10 years
Critères d'accès au partage IPD
Researchers must make a reasonable request to the PI
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .