Managing Our Relationship With Food and Eating

Stress, Psychological Clinical Trial

— NOURISH  

Official title:

Managing Our Relationship With Food and Eating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797689
• Other study ID #: 2021 - 020
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 22, 2021

Study information

• Verified date: July 2021
• Source: University of Lethbridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior
• Eating Habit
• Mental Health Wellness 1
• Stress, Psychological

Intervention

Behavioral:
• Trauma Informed Yoga
One licensed yoga instructor, trained in trauma-informed yoga delivery, will lead the online sessions. Participants will be instructed to engage in the class from a mat or chair in their home or move between them as the class unfolds. The instructor will begin the class by introducing the week's theme (e.g. grounding and safety, non-attachment, imprints of the past and impacts on our reactions to COVID-19, connection to nature), followed by a breath practice (10 min), a yoga practice (50 min), a meditation practice (10 min), and closing words (10 min).
• Trauma Informed Psychotherapy
Two licensed counsellors (MSW-trained) will co-facilitate the online version of this program. Facilitators will begin the session by introducing the week's theme (e.g. setting goals while working from home, being mindful, health coping) (10 min), followed by a lecture and activity to integrate learning (e.g. large and small group discussion using Zoom break out rooms, journaling) (70 min), and closing words (10 min).

Locations

Country	Name	City	State
Canada	University of Lethbridge	Lethbridge	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Lethbridge

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Body Image	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 (a 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)
Other	Changes in Internalized Weight Bias	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 (a = 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)
Other	Changes in Tobacco Use	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)
Other	Changes in Alcohol Use	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)
Other	Changes in Cannabis Use	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)
Other	Changes in Physical Activity and Sedentary Behaviour	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)
Other	Changes in Self-Esteem	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)
Other	Changes in Loneliness	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 a = 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)
Primary	Changes in Intuitive Eating Behaviours	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 (a = 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)
Secondary	Changes in Anxiety and Depression	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)
Secondary	Changes in addictive eating behaviours	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)