Mindfulness, Usual Care
Conditions
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.
Interventions
BEHAVIORALMindfulness
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.
BEHAVIORALUsual 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.
Sponsors
Children's National Research Institute
American University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Body Mass Index (BMI) | Change from Baseline to 6 weeks | Height and weight will be assessed in order to calculate BMI. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Mindfulness |
|---|---|
| Age, Continuous | 14.36 years STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: 6 weeks post study start date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness | Number of Sessions Attended by Participant | 85 percentage of all sessions attended |
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.
Time frame: 6 weeks post study start date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness | Participant Satisfaction: Satisfaction Survey | 4.5 score on a scale | Standard Deviation 0.53 |
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.
Time frame: Change from Baseline to 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness | Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ). | 3.75 Number of days |
Secondary
Body Mass Index (BMI)
Height and weight will be assessed in order to calculate BMI.
Time frame: Change from Baseline to 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness | Body Mass Index (BMI) | 2.91 kg/m^2 |
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.
Time frame: Change from Baseline to 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness | Go No Go False Alarm Rate - Measure of Inhibitory Control | .06 percentage of no gos that are incorrect |
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.
Time frame: Change from Baseline to 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness | Go Reaction Time - Measure of Inhibitory Control | 34.87 milliseconds |
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.
Time frame: Change from Baseline to 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness | Mindful Attention Awareness Scale-Adolescent (MAAS-A) | .20 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness | Overeating - Eating Disorders Examination-Questionnaire (EDEQ). | 1.83 Number of days |