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Managing Our Relationship With Food and Eating (NOURISH)

30. juli 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

158

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Lethbridge, Alberta, Canada, T1K 3M4
        • University of Lethbridge

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Trauma Informed Yoga
Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.
Adfærdsmæssigt: Traume-informeret yoga
En autoriseret yogainstruktør, uddannet i traume-informeret yoga levering, vil lede online sessionerne. Deltagerne vil blive instrueret i at engagere sig i klassen fra en måtte eller stol i deres hjem eller flytte mellem dem, mens klassen udfolder sig. Instruktøren vil begynde klassen med at introducere ugens tema (f. jordforbindelse og sikkerhed, ikke-tilknytning, aftryk fra fortiden og indvirkning på vores reaktioner på COVID-19, forbindelse til naturen), efterfulgt af en åndedrætspraksis (10 min), en yogapraksis (50 min), en meditationspraksis (10 min. min), og afsluttende ord (10 min).
Eksperimentel: Trauma Informed Psychotherapy
Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.
Adfærdsmæssigt: Traume-informeret psykoterapi
To licenserede rådgivere (MSW-uddannede) vil co-facilitere onlineversionen af ​​dette program. Facilitatorer vil begynde sessionen med at introducere ugens tema (f.eks. opstilling af mål, mens du arbejder hjemmefra, er opmærksom, helbredsmæssig mestring) (10 min), efterfulgt af et foredrag og aktivitet for at integrere læring (f.eks. store og små gruppediskussioner ved hjælp af Zoom break-out rum, journalføring) (70 min) og afsluttende ord (10 min).
Ingen indgriben: Control
These participants will not receive an intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Intuitive Eating Behaviours
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Anxiety and Depression
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Body Image
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Lethbridge

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2021

Primær færdiggørelse (Faktiske)

22. juli 2021

Studieafslutning (Faktiske)

22. juli 2021

Datoer for studieregistrering

Først indsendt

10. marts 2021

Først indsendt, der opfyldte QC-kriterier

10. marts 2021

Først opslået (Faktiske)

15. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021 - 020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified data relevant to the researcher's research question may be shared upon a reasonable request

IPD-delingstidsramme

January 2023, for up to 10 years

IPD-delingsadgangskriterier

Researchers must make a reasonable request to the PI

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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