Healthy Behaviors Learning Task and Sleep (NAP)
Sleep Conditioning and Healthy Food Choices
調査の概要
詳細な説明
Over 1/3 of U.S. adults over the age of 20 are obese and obesity is associated with a host of deleterious medical comorbidities, including heart disease, type 2 diabetes, and cancer, costing the U.S. approximately $147 billion annually. Novel approaches to address this public health crisis are needed. Although obesity is multiply determined, it is ultimately a disorder of positive energy balance, such that weight loss requires increases in physical activity and improvements in choosing healthy over unhealthy foods. People who are strongly motivated to eat are more obese, and derive less benefit from weight loss treatments. There are two general approaches to addressing this pattern: 1) increase the reinforcing value of healthy foods and/or 2) increase an individual's self-control, i.e., the ability to inhibit approach responses to less healthy foods.
Emerging research has begun to develop and test training programs that directly modify tendencies to approach one type of stimulus while resisting temptation of another type of stimulus for problems other than obesity. For example, researchers have been able to train heavy drinkers to decrease their weekly alcohol intake7 and chocolate-lovers to reduce their chocolate intake. However, these researchers did not also incorporate increasing interest in alternatives (e.g., drinking water instead of beer). This training mechanism has also yet to be applied to research on obesity and decreasing intake of unhealthy foods.
Participants will be first trained via a computerized training task to inhibit responses to high-calorie (unhealthy) foods, and to approach alternative low-calorie, high-nutrient (healthy) foods, in order to test the tasks efficacy. The investigators will include the training task and incorporate a nap component consistent with Hu and colleagues to evaluate the utility of sleep conditioning for maintaining training-related changes in inhibition and approach tendencies after one week. Tones played during the training task will be played again during the nap, based on randomization
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21224
- Johns Hopkins University Bayview Campus, Behavioral Medicine Research Lab
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age between 20 and 55, inclusive
- Body mass index ≥ 25
- Nonsmoker and non-nicotine user for a minimum of the past 6 months
- Not currently using recreational drugs
- Desire to lose weight
- Difficulty losing weight in the past
- AUDIT: <3 women, <4 men (note: score of 4 is okay if both items 2 and 3=0)
- Pittsburgh Sleep Quality Index questionnaire score <8
- Insomnia Severity Index questionnaire score <10
- Epworth Sleepiness Scale <10
- Below the clinical cutoff for Restless Leg Syndrome
- Full sleep cycle between 8:00pm and 9:00am at least 6 days per week
- Apnea hypopnea index <15, as measured by the Nox-T3
Exclusion Criteria:
- Current diagnosis of diabetes mellitus (type 1 or type 2)
- History of major medical disease impacting study
- Significant unstable medical morbidity within the past 6 months
- Significant unstable psychiatric disorder within the past 6 months
- Current use of antidepressants or opioids.
- Lifetime diagnosis of anorexia nervosa or bulimia nervosa
- Lifetime alcohol or substance abuse disorder or dependence
- Suicidal ideation in past year
- Lifetime serious head injury or stroke judged to impact pain or sleep
- Sleep disorder as assessed via the Structured Interview for sleep disorders (SIS-D).
- Women who are pregnant or lactating.
- Unwilling to follow study procedures
- Other (reason judged by PI)
- Food allergies: Individuals who report any food allergies or any history of anaphylactic reactions related to study procedures during the phone screen for this study will be excluded from participation. Participants who report avoidance of specific foods for other medical reasons (e.g., an interaction between a prescribed medication and a food group, food triggered migraines), if they are related to study procedures, will also be excluded from participation.
- Takes participant more than 30 minutes to fall asleep
- Positive toxicology screen
研究計画
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：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：トリプル
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：Approach/Inhibit group
Participants in the experimental group and control sham sound cues group will complete the Modified Go/No-Go Task. Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring. White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. |
Participants in the experimental group and control sham sound cues group will complete a computerized training task to facilitate learning to respond (press a computer key) to healthy food stimuli and to inhibit responses (not press a computer key) to unhealthy food stimuli.
Participants in the control sham go/no-go group will complete a similar task with common office supplies (approach) and tools (inhibit).
All participants will also complete a 24 hour dietary recall as described below.
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偽コンパレータ：Sham sound cues group
Participants in the experimental group and control sham sound cues group will complete the Modified Go/No-Go Task. Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring. White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. |
Participants in the experimental group and control sham sound cues group will complete a computerized training task to facilitate learning to respond (press a computer key) to healthy food stimuli and to inhibit responses (not press a computer key) to unhealthy food stimuli.
Participants in the control sham go/no-go group will complete a similar task with common office supplies (approach) and tools (inhibit).
All participants will also complete a 24 hour dietary recall as described below.
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偽コンパレータ：Sham go/no-go group
Participants in the control sham go/no-go group will complete a modified Go/No-Go Task with sham approach and inhibit items. Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring. White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. |
Participants in the experimental group and control sham sound cues group will complete a computerized training task to facilitate learning to respond (press a computer key) to healthy food stimuli and to inhibit responses (not press a computer key) to unhealthy food stimuli.
Participants in the control sham go/no-go group will complete a similar task with common office supplies (approach) and tools (inhibit).
All participants will also complete a 24 hour dietary recall as described below.
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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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Reinforcing Value of Food assessed by the Reinforcing Value of Food Questionnaire
時間枠：Approximately 1 week (after second assessment has been taken)
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The reinforcing value of food task (RVF) assesses how hard an individual is willing to hypothetically work to gain access to food compared with an alternative.
A series of paired-samples t-tests will be calculated in order to determine whether participants' scores on the reinforcing value of food test changed between baseline and 1 week later.
Scores on the RVF have been shown to be associated with BMI. as well as obesity and energy intake.
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Approximately 1 week (after second assessment has been taken)
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Delay of Gratification assessed by the Kirby Questionnaire
時間枠：Approximately 1 week (after second assessment has been taken)
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A series of paired-samples t-tests will be calculated in order to determine whether participants' scores on the Kirby Questionnaire changed between baseline and 1 week later.
Each item is scored based on whether the participant chooses the shorter delay and less monetary reward versus the longer delay and a higher monetary reward.
Delay-discounting rates are positively correlated with impulsiveness.
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Approximately 1 week (after second assessment has been taken)
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24 hour dietary recall: Nutrition Data System for Research (NDSR) assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) dietary food recall
時間枠：Approximately 1 week (after second assessment has been taken)
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We will use paired-samples t-tests to determine whether participants mean caloric intake and macronutrient breakdown (e.g., %calories from fat) from the two dietary recalls pre-training task were significantly different from their means post-training task.
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Approximately 1 week (after second assessment has been taken)
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Go/no-go task assessed by the Go/no-go task
時間枠：Approximately 1 week (after second assessment has been taken)
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Performance on go/no-go task as measured by reaction time and accuracy (combined into one score) will be correlated with baseline measures of dietary characteristics and disinhibition
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Approximately 1 week (after second assessment has been taken)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael T Smith, Ph.D、Johns Hopkins University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Modified Go/No-Go Taskの臨床試験
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University GhentShire; Fund for Scientific Research, Flanders, Belgium引きこもった
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University of RochesterNational Cancer Institute (NCI)完了
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Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); United States Department... と他の協力者完了肥満 | 摂食行動
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Klinik ValensKU Leuven; Mindmaze SA完了