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Effect of Mindful Eating on Body Mass Index in Obese Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764113
First Posted: January 9, 2013
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seema Kumar, Mayo Clinic
January 7, 2013
January 9, 2013
January 22, 2014
December 2012
December 2013   (Final data collection date for primary outcome measure)
Body Mass Index [ Time Frame: Baseline and 6 months ]
Body Mass Index would be calculated at baseline, at 3 months and at 6 months
Body Mass Index [ Time Frame: 6 months ]
Body Mass Index would be calculated at baseline, at 3 months and at 6 months
Complete list of historical versions of study NCT01764113 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: Baseline and 6 months ]
Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.
Quality of Life [ Time Frame: 6 months ]
Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.
Fasting glucose [ Time Frame: 6 months ]
Same as current
 
Effect of Mindful Eating on Body Mass Index in Obese Adolescents
Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Adolescent Obesity
  • Behavioral: Mindful Eating
    Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions
  • Behavioral: Standard dietary counselling
  • Experimental: Mindful Eating
    Subjects and at least one of their parents will receive mindful eating based behavioral modification program
    Intervention: Behavioral: Mindful Eating
  • Active Comparator: Standard Dietary Couseling
    Subjects and their parents will receive standard nutritional counseling provided by a registered dietician
    Intervention: Behavioral: Standard dietary counselling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • BMI at or greater than the 95th percentile for age and gender

Exclusion Criteria

Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01764113
12-004401
No
Not Provided
Not Provided
Seema Kumar, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Seema Kumar, MD Mayo Clinic
Mayo Clinic
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP