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Mindfulness in Adolescents With Obesity

Primary Purpose

Mindfulness, Usual Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Usual Care
Sponsored by
American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mindfulness

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's National Medical Center - IDEAL Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Sessions Attended by Participant
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.
Participant Satisfaction: Satisfaction Survey
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 Outcome Measures

Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).
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.
Mindful Attention Awareness Scale-Adolescent (MAAS-A)
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.
"Go" Reaction Time - Measure of Inhibitory Control
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.
Body Mass Index (BMI)
Height and weight will be assessed in order to calculate BMI.
Overeating - Eating Disorders Examination-Questionnaire (EDEQ).
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.
Go No Go False Alarm Rate - Measure of Inhibitory Control
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.

Full Information

First Posted
March 7, 2019
Last Updated
March 19, 2021
Sponsor
American University
Collaborators
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03874377
Brief Title
Mindfulness in Adolescents With Obesity
Official Title
Examining the Feasibility of a Brief Adjunctive Mindfulness Intervention for Adolescents With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University
Collaborators
Children's National Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Usual Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Number of Sessions Attended by Participant
Description
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.
Time Frame
6 weeks post study start date
Title
Participant Satisfaction: Satisfaction Survey
Description
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.
Time Frame
6 weeks post study start date
Secondary Outcome Measure Information:
Title
Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).
Description
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.
Time Frame
Change from Baseline to 6 weeks
Title
Mindful Attention Awareness Scale-Adolescent (MAAS-A)
Description
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.
Time Frame
Change from Baseline to 6 weeks
Title
"Go" Reaction Time - Measure of Inhibitory Control
Description
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.
Time Frame
Change from Baseline to 6 weeks
Title
Body Mass Index (BMI)
Description
Height and weight will be assessed in order to calculate BMI.
Time Frame
Change from Baseline to 6 weeks
Title
Overeating - Eating Disorders Examination-Questionnaire (EDEQ).
Description
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.
Time Frame
Change from Baseline to 6 weeks
Title
Go No Go False Alarm Rate - Measure of Inhibitory Control
Description
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.
Time Frame
Change from Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's National Medical Center - IDEAL Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32518670
Citation
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.
Results Reference
derived

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Mindfulness in Adolescents With Obesity

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