Effect of Mindful Eating on Body Mass Index in Obese Adolescents

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01764113
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Obesity	Behavioral: Mindful Eating; Behavioral: Standard dietary counselling	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Body Mass Index [Baseline and 6 months]

   Body Mass Index would be calculated at baseline, at 3 months and at 6 months

Secondary Outcome Measures

1. Quality of Life [Baseline and 6 months]

   Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.

Other Outcome Measures

1. Fasting glucose [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

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

Exclusion Criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Seema Kumar, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seema Kumar, Assistant Professor of Pediatrics, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01764113
• Other Study ID Numbers: 12-004401
• First Posted: Jan 9, 2013
• Last Update Posted: Jan 22, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Seema Kumar, Assistant Professor of Pediatrics, Mayo Clinic: Obesity; Adolescence; Mindful Eating
• Additional relevant MeSH terms: Pediatric Obesity

Study Results

No Results Posted as of Jan 22, 2014