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OpenTrials
Completed

NCT Number: NCT03874377

Mindfulness in Adolescents With Obesity

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.

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Key information

Conditions

Mindfulness Usual Care

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Medical Center - IDEAL Clinic

Washington D.C., District of Columbia, 20001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mindfulness

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

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.

Primary outcomes

  1. Number of Sessions Attended by Participant

    Time frame: 6 weeks post study start date

    Retention will be tracked via attendance; research staff will take attendance during each assessment period and intervention session to determine the feasibility of retaining participants.

  2. Participant Satisfaction: Satisfaction Survey

    Time frame: 6 weeks post study start date

    We will assess participants' satisfaction with the intervention by having them complete a satisfaction survey at the end of the program to assess perceived helpfulness of the intervention and to elicit feedback on the various components. Participants respond to 6 questions (e.g., "I enjoyed being a part of this program") on a scale of 1 (strongly disagree) to 5 (strongly agree). An average across scores will be calculated with higher scores reflecting greater satisfaction. Possible scores range from 1 to 5.

Secondary outcomes

  1. Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).

    Time frame: Change from Baseline to 6 weeks

    Participants will report instances of binge eating via items of the Eating Disorders Examination-Questionnaire (EDEQ). Participants report how often they engaged in binge eating over the past 28 days 0 (no days) to 28 (every day). Higher scores represent greater eating pathology.

  2. Mindful Attention Awareness Scale-Adolescent (MAAS-A)

    Time frame: Change from Baseline to 6 weeks

    Participants rate how frequently they experience episodes of mindless behavior via the Mindful Attention Awareness Scale-Adolescent (MAAS-A). The MAAS-A is a 15-item measure of dispositional mindfulness. Participants respond to statements on a scale from 1 (almost always) to 6 (almost never). Items are summed with scores ranging from 15 to 90, with higher scores representing higher levels of mindfulness.

  3. "Go" Reaction Time - Measure of Inhibitory Control

    Time frame: Change from Baseline to 6 weeks

    The Go No Go Task examines inhibitory control via a computerized program. Participants are instructed to press a button when a certain image is shown on the screen (e.g., a green rectangle, a cross). They are instructed not to respond when another image is shown on the screen (e.g., a blue rectangle, an X). Poor inhibitory control is evident by more failures to inhibit responses in the "no go" condition. Reaction time is the processing speed for correct Go trials.

  4. Body Mass Index (BMI)

    Time frame: Change from Baseline to 6 weeks

    Height and weight will be assessed in order to calculate BMI.

  5. Overeating - Eating Disorders Examination-Questionnaire (EDEQ).

    Time frame: Change from Baseline to 6 weeks

    Participants report instances of overeating via items of the Eating Disorders Examination-Questionnaire (EDEQ). Participants report how often they engaged in overeating over the past 28 days 0 (no days) to 28 (every day). Higher scores represent greater overeating.

  6. Go No Go False Alarm Rate - Measure of Inhibitory Control

    Time frame: Change from Baseline to 6 weeks

    The Go No Go Task examines inhibitory control via a computerized program. Participants are instructed to press a button when a certain image is shown on the screen (e.g., a green rectangle, a cross). They are instructed not to respond when another image is shown on the screen (e.g., a blue rectangle, an X). Poor inhibitory control is evident by more failures to inhibit responses in the "no go" condition. The false alarm rate refers to incorrect No Go trials.

Sponsors and collaborators

Lead sponsor

American University

Other

Collaborators

  • Children's National Research Institute

Registry information

Official study title

Examining the Feasibility of a Brief Adjunctive Mindfulness Intervention for Adolescents With Obesity

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 14, 2019
Registry last updated
Apr 14, 2021

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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