Effect of Mindful Eating on Body Mass Index in Obese Adolescents

NCT ID: NCT01764113

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adolescent Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindful Eating

Subjects and at least one of their parents will receive mindful eating based behavioral modification program

Group Type EXPERIMENTAL

Mindful Eating

Intervention Type BEHAVIORAL

Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions

Standard Dietary Couseling

Subjects and their parents will receive standard nutritional counseling provided by a registered dietician

Group Type ACTIVE_COMPARATOR

Standard dietary counselling

Intervention Type BEHAVIORAL

Interventions

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Mindful Eating

Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions

Intervention Type BEHAVIORAL

Standard dietary counselling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI at or greater than the 95th percentile for age and gender
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Seema Kumar

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seema Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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12-004401

Identifier Type: -

Identifier Source: org_study_id

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