Clinical trial NCT03874377: Mindfulness in Adolescents With Obesity
Official title: Examining the Feasibility of a Brief Adjunctive Mindfulness Intervention for Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Usual Care
Lead sponsor: American University
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2019-03-14
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Sessions Attended by Participant
timeFrame: 6 weeks post study start date
measure: Participant Satisfaction: Satisfaction Survey
timeFrame: 6 weeks post study start date
Secondary outcomes:
measure: Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).
timeFrame: Change from Baseline to 6 weeks
measure: Mindful Attention Awareness Scale-Adolescent (MAAS-A)
timeFrame: Change from Baseline to 6 weeks
measure: "Go" Reaction Time - Measure of Inhibitory Control
timeFrame: Change from Baseline to 6 weeks
measure: Body Mass Index (BMI)
timeFrame: Change from Baseline to 6 weeks
measure: Overeating - Eating Disorders Examination-Questionnaire (EDEQ).
timeFrame: Change from Baseline to 6 weeks
measure: Go No Go False Alarm Rate - Measure of Inhibitory Control
timeFrame: Change from Baseline to 6 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center - IDEAL Clinic
state: District of Columbia
Study officials:
References:
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.