Mindfulness in Adolescents With Obesity

• Sponsor: American University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03874377
• Collaborator: Children's National Research Institute (Other)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.4
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness; Usual Care	Behavioral: Mindfulness; Behavioral: Usual Care	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Examining the Feasibility of a Brief Adjunctive Mindfulness Intervention for Adolescents With Obesity
• Actual Study Start Date: Feb 19, 2019
• Actual Primary Completion Date: Aug 31, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Sessions Attended by Participant [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 [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 Outcome Measures

1. Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ). [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) [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 [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) [Change from Baseline to 6 weeks]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's National Medical Center - IDEAL Clinic	Washington	District of Columbia	United States	20001

Sponsors and Collaborators

• American University
• Children's National Research Institute

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 22, 2021

More Information

Publications

None provided.

• Responsible Party: Elizabeth Cotter, Assistant Professor, American University
• ClinicalTrials.gov Identifier: NCT03874377
• Other Study ID Numbers: CNMC Pro00011128
• First Posted: Mar 14, 2019
• Last Update Posted: Apr 14, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Mindfulness
Arm/Group 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.
Period Title: Overall Study
STARTED	11
COMPLETED	8
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Mindfulness
Arm/Group 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.
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.36 (1.90)
Sex: Female, Male (Count of Participants)
Female	8 72.7%
Male	3 27.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 63.6%
White	2 18.2%
More than one race	2 18.2%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	11
Number [percentage of all sessions attended]	85

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	8
Mean (Standard Deviation) [score on a scale]	4.5 (.53)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	11
Mean (95% Confidence Interval) [Number of days]	3.75

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	11
Mean (95% Confidence Interval) [score on a scale]	.20

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	11
Mean (95% Confidence Interval) [milliseconds]	34.87

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	11
Mean (95% Confidence Interval) [kg/m^2]	2.91

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	11
Mean (95% Confidence Interval) [Number of days]	1.83

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness
Arm/Group 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.
Measure Participants	11
Mean (95% Confidence Interval) [percentage of "no gos that are incorrect]	.06

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Mindfulness
Arm/Group 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.
All Cause Mortality
	Mindfulness
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	Mindfulness
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.