Mindfulness in Adolescents With Obesity
19 mars 2021 mis à jour par: Elizabeth Cotter, American University
Examining the Feasibility of a Brief Adjunctive Mindfulness Intervention for Adolescents With Obesity
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
11
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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District of Columbia
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Washington, District of Columbia, États-Unis, 20001
- Children's National Medical Center - IDEAL Clinic
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
12 ans à 17 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Sessions Attended by Participant
Délai: 6 weeks post study start date
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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.
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6 weeks post study start date
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Participant Satisfaction: Satisfaction Survey
Délai: 6 weeks post study start date
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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.
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6 weeks post study start date
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).
Délai: 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.
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Change from Baseline to 6 weeks
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Mindful Attention Awareness Scale-Adolescent (MAAS-A)
Délai: Change from Baseline to 6 weeks
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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.
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Change from Baseline to 6 weeks
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"Go" Reaction Time - Measure of Inhibitory Control
Délai: Change from Baseline to 6 weeks
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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.
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Change from Baseline to 6 weeks
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Body Mass Index (BMI)
Délai: Change from Baseline to 6 weeks
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Height and weight will be assessed in order to calculate BMI.
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Change from Baseline to 6 weeks
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Overeating - Eating Disorders Examination-Questionnaire (EDEQ).
Délai: 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.
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Change from Baseline to 6 weeks
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Go No Go False Alarm Rate - Measure of Inhibitory Control
Délai: 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.
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Change from Baseline to 6 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
19 février 2019
Achèvement primaire (Réel)
31 août 2019
Achèvement de l'étude (Réel)
1 juin 2020
Dates d'inscription aux études
Première soumission
7 mars 2019
Première soumission répondant aux critères de contrôle qualité
12 mars 2019
Première publication (Réel)
14 mars 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 avril 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 mars 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CNMC Pro00011128
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
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