Managing Our Relationship With Food and Eating (NOURISH)
30. července 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
158
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alberta
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Lethbridge, Alberta, Kanada, T1K 3M4
- University of Lethbridge
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Trauma Informed Yoga
Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.
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Online lekce povede jeden licencovaný instruktor jógy, vyškolený v poskytování jógy na základě traumatu.
Účastníci budou instruováni, aby se zapojili do třídy z podložky nebo židle ve svém domě nebo se mezi nimi pohybovali, jak se třída vyvíjí.
Vyučující zahájí hodinu představením tématu týdne (např.
uzemnění a bezpečí, nepřipoutanost, otisky minulosti a dopady na naše reakce na COVID-19, spojení s přírodou), následuje dechová praxe (10 min), cvičení jógy (50 min), meditační praxe (10 min) a závěrečná slova (10 min).
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Experimentální: Trauma Informed Psychotherapy
Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.
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Dva licencovaní poradci (vyškolení na MSW) budou spoluusnadňovat online verzi tohoto programu.
Facilitátoři zahájí relaci představením tématu týdne (např.
stanovení cílů při práci z domova, všímavost, zvládání zdravotního stavu) (10 min), následuje přednáška a aktivita k integraci učení (např.
diskuse ve velkých a malých skupinách pomocí Zoom breakout rooms, žurnálování) (70 min) a závěrečných slov (10 min).
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Žádný zásah: Control
These participants will not receive an intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes in Intuitive Eating Behaviours
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Changes in Anxiety and Depression
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes in Body Image
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. dubna 2021
Primární dokončení (Aktuální)
22. července 2021
Dokončení studie (Aktuální)
22. července 2021
Termíny zápisu do studia
První předloženo
10. března 2021
První předloženo, které splnilo kritéria kontroly kvality
10. března 2021
První zveřejněno (Aktuální)
15. března 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. srpna 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. července 2021
Naposledy ověřeno
1. července 2021
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2021 - 020
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De-identified data relevant to the researcher's research question may be shared upon a reasonable request
Časový rámec sdílení IPD
January 2023, for up to 10 years
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Klinické studie na Stres, psychologický
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VA Office of Research and DevelopmentVA St. Louis Health Care SystemUkončenoVeteráni podle St. Louis VAMC Stress TesSpojené státy