NCT04531436

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 11, 2020

Last Update Submit

August 26, 2020

Conditions

Keywords

Mindful eatingOverweightObesityIntuitive eatingOvereatingSelf-compassion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in body weight

    Baseline, week 9, and 24-week follow-up

Other Outcomes (4)

  • Change in mindful eating

    Baseline, week 7, 24-week follow-up

  • Self-compassion

    Baseline

  • Change in intuitive eating

    Baseline, week 7, 24-week follow-up

  • +1 more other outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Brief mindful eating intervention

Other: Brief mindful eating intervention

Interventions

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).

Intervention

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 25 to 45 kg/m2 (overweight/obese)
  • Willingness to commit to program and complete various assessment measures

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A1G1, Canada

Location

MeSH Terms

Conditions

HyperphagiaOverweightObesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Bärbel Knauper, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot feasibility trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
James McGill Professor

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 28, 2020

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations