Mindfulness in Adolescents With Obesity
19 de março de 2021 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
11
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20001
- Children's National Medical Center - IDEAL Clinic
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
12 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Sessions Attended by Participant
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).
Prazo: Change from Baseline to 6 weeks
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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)
Prazo: 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
Prazo: 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)
Prazo: 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).
Prazo: Change from Baseline to 6 weeks
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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
Prazo: 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.
The false alarm rate refers to incorrect No Go trials.
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Change from Baseline to 6 weeks
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Colaboradores e Investigadores
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Patrocinador
Colaboradores
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de fevereiro de 2019
Conclusão Primária (Real)
31 de agosto de 2019
Conclusão do estudo (Real)
1 de junho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
7 de março de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de março de 2019
Primeira postagem (Real)
14 de março de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de março de 2021
Última verificação
1 de março de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CNMC Pro00011128
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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