Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
11 participants
INTERVENTIONAL
2019-02-19
2020-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
NCT03611660
Mindfulness Training to Promote Healthy Diet and Physical Activity in Teens
NCT01975896
Family-Based Mindful Eating Intervention for Overweight Adolescents
NCT02114190
Parent Mentor Interventions for Early Childhood Obesity
NCT03330743
Family Based Mindfulness Intervention
NCT01974102
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* a current patient of our affiliated obesity clinic
* have a body mass index (BMI) between 30 and 45 kg/m2.
Exclusion Criteria
* 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
12 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's National Research Institute
OTHER
American University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elizabeth Cotter
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's National Medical Center - IDEAL Clinic
Washington D.C., District of Columbia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNMC Pro00011128
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.