Managing Our Relationship With Food and Eating

NCT04797689 | Completed

• 1 other identifier: 2021 - 020
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 (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)

Secondary Outcomes (2)

• Changes in Anxiety and Depression

  Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)

• Changes in addictive eating behaviours

  Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)

Other Outcomes (8)

• Changes in Body Image

  Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)

• Changes in Internalized Weight Bias

  Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)

• Changes in Tobacco Use

  Baseline, Mid-point (6 weeks), Post-Intervention (12 weeks)

Study Arms (3)

Trauma Informed Yoga

EXPERIMENTAL

Participants will receive 12 x 60 min group-based yoga sessions, delivered synchronously over Zoom.

Behavioral: Trauma Informed Yoga

Trauma Informed Psychotherapy

EXPERIMENTAL

Participants will receive 12 x 120 min group-based psychotherapy sessions, delivered synchronously over Zoom.

Behavioral: Trauma Informed Psychotherapy

Control

NO INTERVENTION

These participants will not receive an intervention.

Interventions

Trauma Informed Yoga BEHAVIORAL

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 Yoga

Trauma Informed Psychotherapy BEHAVIORAL

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).

Trauma Informed Psychotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-community dwelling
• Not currently residing in Alberta, Canada

Sponsors & Collaborators

• University of Lethbridge: lead

Study Sites (1)

University of Lethbridge

Lethbridge, Alberta, T1K 3M4, Canada

Location

MeSH Terms

Conditions

Feeding Behavior; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Behavioral Symptoms

Study Officials

• Cheryl Currie, PhD

  University of Lethbridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2021
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: January 2023, for up to 10 years
• Access Criteria: Researchers must make a reasonable request to the PI

Locations

CA (1)