Effect of Mindful Eating on Body Mass Index in Obese Adolescents

Adolescent Obesity Clinical Trial

Official title:

Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764113
• Other study ID #: 12-004401
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2013
• Last updated: January 21, 2014
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

Inclusion Criteria

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

Exclusion Criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Mindful Eating
Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions
• Standard dietary counselling

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting glucose		6 months	No
Primary	Body Mass Index	Body Mass Index would be calculated at baseline, at 3 months and at 6 months	Baseline and 6 months	No
Secondary	Quality of Life	Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.	Baseline and 6 months	No