Mindfulness in Adolescents With Obesity
2021年3月19日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
11
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20001
- Children's National Medical Center - IDEAL Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Sessions Attended by Participant
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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).
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年2月19日
一次修了 (実際)
2019年8月31日
研究の完了 (実際)
2020年6月1日
試験登録日
最初に提出
2019年3月7日
QC基準を満たした最初の提出物
2019年3月12日
最初の投稿 (実際)
2019年3月14日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月14日
QC基準を満たした最後の更新が送信されました
2021年3月19日
最終確認日
2021年3月1日
詳しくは
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