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Effect of Mindful Eating on Body Mass Index in Obese Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seema Kumar, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01764113
First received: January 7, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Adolescent Obesity
Behavioral: Mindful Eating
Behavioral: Standard dietary counselling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Body Mass Index would be calculated at baseline, at 3 months and at 6 months


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.


Other Outcome Measures:
  • Fasting glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindful Eating
Subjects and at least one of their parents will receive mindful eating based behavioral modification program
Behavioral: Mindful Eating
Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions
Active Comparator: Standard Dietary Couseling
Subjects and their parents will receive standard nutritional counseling provided by a registered dietician
Behavioral: Standard dietary counselling

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

Exclusion Criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764113

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Seema Kumar, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Seema Kumar, Assistant Professor of Pediatrics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01764113     History of Changes
Other Study ID Numbers: 12-004401
Study First Received: January 7, 2013
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Obesity
Adolescence
Mindful Eating

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014