NCT01616368

Brief Summary

The investigators propose to study the effect of mindfulness training on the eating behaviors and dietary intake of overweight or obese persons. Mindfulness skills training involves bringing non-judgmental attention to thoughts, emotions and bodily sensations - including hunger and satiety cues. It is hypothesized that as subjects advance through the 8-week class series, developing their capacity for mindfulness and in effect learn to pay attention to the sensations, assumptions, cognitions, and beliefs that underlie their eating behaviors, that their eating behaviors will improve. Specifically, the investigators hypothesize that 1) there will be significant improvements in the areas of uncontrolled and emotional eating, 2) there will be significant decreases in total caloric intake and significant increases in fruits and vegetables, and 3) there will be a positive significant relationship between the frequency/consistency of mindfulness practice and improvements from baseline to follow-up measures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for early_phase_1 obesity

Timeline
Completed

Started Jan 2012

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

June 6, 2012

Last Update Submit

November 18, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Eating behaviors

    The TFEQ will be administered. Subscales for emotional eating, uncontrolled eating and cognitive restraint will be assessed

    baseline, 2 months, 5 months

Secondary Outcomes (1)

  • Change in Nutrition intake

    baseline, 2 months, 5 months

Study Arms (1)

MEAL

EXPERIMENTAL

Participation in an 8-week mindful eating course

Behavioral: Mindful Eating and Living Course

Interventions

An eight week course designed to teach mindfulness skills with an emphasis on mindful eating.

Also known as: MEAL
MEAL

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index (BMI) \> 26

You may not qualify if:

  • Psychotic disorders
  • Poorly controlled bipolar disorder
  • Borderline or antisocial personality disorder
  • A diagnosed eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityFeeding Behavior

Interventions

Meals

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • David Kearney, MD

    Seattle Institute for Biomedical and Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 11, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 20, 2014

Record last verified: 2014-11