Mindfulness in Adolescents With Obesity

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874377
• Other study ID #: CNMC Pro00011128
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2021
• Source: American University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 1, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness
• Obesity
• Usual Care

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's National Medical Center - IDEAL Clinic	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
American University	Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks post study start date
Primary	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.	6 weeks post study start date
Secondary	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.	Change from Baseline to 6 weeks
Secondary	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.	Change from Baseline to 6 weeks
Secondary	"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.	Change from Baseline to 6 weeks
Secondary	Body Mass Index (BMI)	Height and weight will be assessed in order to calculate BMI.	Change from Baseline to 6 weeks
Secondary	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.	Change from Baseline to 6 weeks
Secondary	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.	Change from Baseline to 6 weeks