Managing Our Relationship With Food and Eating (NOURISH)
30 juli 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
158
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alberta
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Lethbridge, Alberta, Canada, T1K 3M4
- University of Lethbridge
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Trauma Informed Yoga
Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.
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Een gediplomeerde yoga-instructeur, getraind in trauma-geïnformeerde yoga-levering, zal de online sessies leiden.
Deelnemers worden geïnstrueerd om deel te nemen aan de les vanaf een mat of stoel in hun huis of tussen hen in te bewegen terwijl de les zich ontvouwt.
De instructeur begint de les met het introduceren van het thema van de week (bijv.
aarding en veiligheid, niet-gehechtheid, indrukken uit het verleden en impact op onze reacties op COVID-19, verbinding met de natuur), gevolgd door een ademoefening (10 min), een yoga-oefening (50 min), een meditatie-oefening (10 min) en slotwoorden (10 min).
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Experimenteel: Trauma Informed Psychotherapy
Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.
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Twee gediplomeerde counselors (opgeleid door MSW) zullen de online versie van dit programma mede faciliteren.
Facilitators beginnen de sessie met een introductie van het thema van de week (bijv.
doelen stellen tijdens thuiswerken, mindful zijn, omgaan met gezondheid) (10 min), gevolgd door een lezing en activiteit om leren te integreren (bijv.
grote en kleine groepsdiscussie met behulp van Zoom break-out rooms, journaling) (70 min) en afsluitende woorden (10 min).
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Geen tussenkomst: Control
These participants will not receive an intervention.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in Intuitive Eating Behaviours
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in Anxiety and Depression
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in Body Image
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 april 2021
Primaire voltooiing (Werkelijk)
22 juli 2021
Studie voltooiing (Werkelijk)
22 juli 2021
Studieregistratiedata
Eerst ingediend
10 maart 2021
Eerst ingediend dat voldeed aan de QC-criteria
10 maart 2021
Eerst geplaatst (Werkelijk)
15 maart 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 augustus 2021
Laatste update ingediend die voldeed aan QC-criteria
30 juli 2021
Laatst geverifieerd
1 juli 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021 - 020
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
De-identified data relevant to the researcher's research question may be shared upon a reasonable request
IPD-tijdsbestek voor delen
January 2023, for up to 10 years
IPD-toegangscriteria voor delen
Researchers must make a reasonable request to the PI
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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