Clinical trial NCT04797689: Managing Our Relationship With Food and Eating
Official title: Managing Our Relationship With Food and Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Eating Behavior
Stress, Psychological
Eating Habit
Lead sponsor: University of Lethbridge
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Intuitive Eating Behaviours
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
Secondary outcomes:
measure: Changes in Anxiety and Depression
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in addictive eating behaviours
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
Other outcomes:
measure: Changes in Body Image
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in Internalized Weight Bias
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in Tobacco Use
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in Alcohol Use
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in Cannabis Use
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in Physical Activity and Sedentary Behaviour
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in Self-Esteem
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
measure: Changes in Loneliness
timeFrame: Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)
Locations:
city: Lethbridge
country: Canada
facility: University of Lethbridge
state: Alberta
Study officials:
affiliation: University of Lethbridge
name: Cheryl Currie, PhD
role: PRINCIPAL_INVESTIGATOR
References: