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OpenTrials
Completed

NCT Number: NCT01764113

Effect of Mindful Eating on Body Mass Index in Obese Adolescents

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.

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Key information

Conditions

Adolescent Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Mindful Eating

Behavioral

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

Standard dietary counselling

Behavioral

Primary outcomes

  1. Body Mass Index

    Time frame: Baseline and 6 months

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

Secondary outcomes

  1. Quality of Life

    Time frame: Baseline and 6 months

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

Other outcomes

  1. Fasting glucose

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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