Back to resultsEffect of Mindful Eating on Body Mass Index in Obese Adolescents
Primary Purpose
Adolescent Obesity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mindful Eating
Standard dietary counselling
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Obesity focused on measuring Obesity, Adolescence, Mindful Eating
Eligibility Criteria
Inclusion Criteria
- BMI at or greater than the 95th percentile for age and gender
Exclusion Criteria
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindful Eating
Standard Dietary Couseling
Arm Description
Subjects and at least one of their parents will receive mindful eating based behavioral modification program
Subjects and their parents will receive standard nutritional counseling provided by a registered dietician
Outcomes
Primary Outcome Measures
Body Mass Index
Body Mass Index would be calculated at baseline, at 3 months and at 6 months
Secondary Outcome Measures
Quality of Life
Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01764113
Brief Title
Effect of Mindful Eating on Body Mass Index in Obese Adolescents
Official Title
Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to study the effect of a family based mindfulness training program with special focus on diet and nutrition on weight and cardiovascular risk markers in obese adolescents.
Detailed Description
40 obese adolescents would be randomized into either a mindfulness based behavioral modification program or standard dietary counseling. At least one parent would be expected to attend the counseling sessions. Patients would be followed for a period of 6 months. Anthropometric parameters, questionaiires relating to quality of life and blood tests would be drawn at baseline and and at 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity
Keywords
Obesity, Adolescence, Mindful Eating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindful Eating
Arm Type
Experimental
Arm Description
Subjects and at least one of their parents will receive mindful eating based behavioral modification program
Arm Title
Standard Dietary Couseling
Arm Type
Active Comparator
Arm Description
Subjects and their parents will receive standard nutritional counseling provided by a registered dietician
Intervention Type
Behavioral
Intervention Name(s)
Mindful Eating
Intervention Description
Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions
Intervention Type
Behavioral
Intervention Name(s)
Standard dietary counselling
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Body Mass Index would be calculated at baseline, at 3 months and at 6 months
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Fasting glucose
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
BMI at or greater than the 95th percentile for age and gender
Exclusion Criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seema Kumar, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Effect of Mindful Eating on Body Mass Index in Obese Adolescents
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