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
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
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014