Mindfulness in Adolescents With Obesity

NCT ID: NCT03874377

Last Updated: 2021-04-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-19

Study Completion Date

2020-06-01

Brief Summary

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The goal of this study is to conduct a single arm open trial to examine the feasibility of a brief, adjunctive mindfulness intervention tailored to the needs of adolescents with severe obesity.

Detailed Description

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The purpose of this study is to examine whether it is feasible to integrate a brief, adjunctive mindfulness intervention with the standard medical management of obesity in adolescents with severe obesity. Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. Mindfulness training enhances one's ability to cope with negative emotions and one's awareness of decision-making processes and internal experiences.

The proposed study has two specific aims: 1) to conduct a single arm open trial to examine the feasibility and acceptability of the mindfulness intervention in a sample of 15 adolescents with severe obesity; and 2) to examine the preliminary efficacy of the mindfulness intervention on BMI, emotion regulation, eating and weight-related behaviors, impulsivity, waist circumference, and blood pressure in comparison to the standard of care.

Conditions

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Mindfulness Usual Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness

The mindfulness intervention consists of 6 weekly sessions, blending material from the evidence-based Learning to BREATHE and Mindfulness-Based Eating Awareness Training manualized interventions. Sessions will focus on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.Participants in this arm will also receive the usual care provided by the weight management clinic.

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. The mindfulness intervention consists of 6 weekly sessions focused on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.

Usual Care

Intervention Type BEHAVIORAL

Participants will receive the recommended standard of medical management of overweight and obesity. The clinic team conducts a comprehensive evaluation of the patient to assess dietary and activity behavior change needs of each patient and family, as well as obesity-associated comorbidities. In addition to management of comorbidities, goals for improved physical activity and dietary behaviors are set with the patient and family at each visit.

Interventions

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Mindfulness

Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. The mindfulness intervention consists of 6 weekly sessions focused on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.

Intervention Type BEHAVIORAL

Usual Care

Participants will receive the recommended standard of medical management of overweight and obesity. The clinic team conducts a comprehensive evaluation of the patient to assess dietary and activity behavior change needs of each patient and family, as well as obesity-associated comorbidities. In addition to management of comorbidities, goals for improved physical activity and dietary behaviors are set with the patient and family at each visit.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* between the ages of 12 - 17 years
* a current patient of our affiliated obesity clinic
* have a body mass index (BMI) between 30 and 45 kg/m2.

Exclusion Criteria

* have a known genetic cause of obesity
* have been diagnosed with a severe intellectual or learning disability
* have been diagnosed with an autism spectrum disorder or current psychosis
* are taking a medication intended to reduce body weight
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's National Research Institute

OTHER

Sponsor Role collaborator

American University

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Cotter

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's National Medical Center - IDEAL Clinic

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Cotter EW, Hornack SE, Fotang JP, Pettit E, Mirza NM. A pilot open-label feasibility trial examining an adjunctive mindfulness intervention for adolescents with obesity. Pilot Feasibility Stud. 2020 Jun 6;6:79. doi: 10.1186/s40814-020-00621-1. eCollection 2020.

Reference Type DERIVED
PMID: 32518670 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CNMC Pro00011128

Identifier Type: -

Identifier Source: org_study_id

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