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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01616368
Other study ID # MIRB 00458
Secondary ID
Status Completed
Phase Phase 0
First received June 6, 2012
Last updated November 18, 2014
Start date January 2012
Est. completion date January 2013

Study information

Verified date November 2014
Source Seattle Institute for Biomedical and Clinical Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Body Mass Index (BMI) > 26

Exclusion Criteria:

- Psychotic disorders

- Poorly controlled bipolar disorder

- Borderline or antisocial personality disorder

- A diagnosed eating disorder

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindful Eating and Living Course
An eight week course designed to teach mindfulness skills with an emphasis on mindful eating.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Seattle Institute for Biomedical and Clinical Research American College of Gastroenterology

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Change in Nutrition intake The ASA-24 and the DHQ will be administered to assess nutritional intake baseline, 2 months, 5 months No
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