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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04531436
Other study ID # 46-0617
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date September 1, 2018

Study information

Verified date August 2020
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project evaluated the effects of a brief manualized mindful eating intervention as a treatment for overeating with individuals with overweight and obesity.


Description:

Overeating leads to overweight and obesity. Effective eating regulation largely depends on an individual's responsiveness to internal cues of physiological hunger and satiety; this phenomenon is known as interoceptive awareness and has been shown to be lower in individuals with overweight or obesity. Mindfulness training may improve interoceptive awareness and thus may facilitate more effective regulation of eating through increased sensitivity to cues of hunger and fullness. Mindful eating programs have been shown to increase interoceptive awareness of hunger and satiety cues and decrease weight in individuals with obesity. Although these programs are effective, they involve lengthy group sessions, require extensively trained staff, and are not widely available outside of clinical research. Thus, the reach and impact of these programs are limited.

The present study developed and tested a brief mindful eating intervention inspired by Kristeller & Wolever's (2010) Mindfulness-Based Eating Awareness Training program to increase interoceptive awareness in individuals with overweight and obesity as a means to increase mindful and intuitive eating, reduce overeating and facilitate weight loss. The program consisted of 9 weekly 10-15 minute sessions structured around one simple evidence-based mindful eating exercise, and was delivered to adult (ages 18-67) employees from a Canadian university.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria:

- BMI of 25 to 45 kg/m2 (overweight/obese)

- Willingness to commit to program and complete various assessment measures

Exclusion Criteria:

- Having been pregnant in the past six months or planning on becoming pregnant in the next year

- Undergoing treatment for cancer

- Using medications that affect body weight or appetite

- Being diagnosed with bulimia nervosa, binge-eating disorder, major depressive disorder, or another severe psychiatric disease (including dementia)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Brief mindful eating intervention
Over the 9-week intervention, participants will be introduced to various mindful eating and intuitive eating practices which are aimed at reducing overeating and facilitating weight loss. Each session will focus on one simple, evidence-based message, aimed at modifying a current weight-relevant eating behavior of the patient. The intervention will focus on two key elements: (1) the mindful awareness of body cues (intuitive eating) and (2) the mindful awareness of external cues (mindful eating).

Locations

Country Name City State
Canada McGill University Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in mindful eating As measured by the Mindful Eating Questionnaire. Scores can range between 28 and 112, with higher scores indicating greater levels of mindful eating Baseline, week 7, 24-week follow-up
Other Self-compassion As measured by the Self-Compassion Scale Short Form. Scores range between 26 and 130, with higher scores indicating greater levels of self-compassion Baseline
Other Change in intuitive eating As measured by the Intuitive Eating Scale. Scores can range from 21 to 105, with higher scores indicating greater levels of intuitive eating Baseline, week 7, 24-week follow-up
Other Cognitive restraint As measured by the cognitive restraint subscale of the Three Factor Eating Questionnaire. Scores for this subscale range between 3 and 12, with higher scores indicating greater levels of cognitive restraint Baseline
Primary Change in overeating As measured by the Overeating Questionnaire. Scores can range from 0 to 40, with higher scores indicating a greater tendency to overeat Baseline, week 9, and 24-week follow-up
Secondary Change in body weight Change in body weight (lbs) Baseline, week 9, and 24-week follow-up
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