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Healthy Behaviors Learning Task and Sleep (NAP)

6. září 2022 aktualizováno: Johns Hopkins University

Sleep Conditioning and Healthy Food Choices

This research is being done to study the impacts of a computerized learning task on health behaviors. The investigators are interested in studying whether this computerized learning task can help with weight loss.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Aktuální)

25

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21224
        • Johns Hopkins University Bayview Campus, Behavioral Medicine Research Lab

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 55 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Modified Go/No-Go Task
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.
Falešný srovnávač: 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.
Behaviorální: Modified Go/No-Go Task
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.
Falešný srovnávač: 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.
Behaviorální: Modified Go/No-Go Task
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reinforcing Value of Food assessed by the Reinforcing Value of Food Questionnaire
Časové okno: Approximately 1 week (after second assessment has been taken)
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.
Approximately 1 week (after second assessment has been taken)
Delay of Gratification assessed by the Kirby Questionnaire
Časové okno: Approximately 1 week (after second assessment has been taken)
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.
Approximately 1 week (after second assessment has been taken)
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
Časové okno: Approximately 1 week (after second assessment has been taken)
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.
Approximately 1 week (after second assessment has been taken)
Go/no-go task assessed by the Go/no-go task
Časové okno: Approximately 1 week (after second assessment has been taken)
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
Approximately 1 week (after second assessment has been taken)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Johns Hopkins University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Michael T Smith, Ph.D, Johns Hopkins University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2016

Primární dokončení (Aktuální)

28. října 2021

Dokončení studie (Aktuální)

30. srpna 2022

Termíny zápisu do studia

První předloženo

20. září 2016

První předloženo, které splnilo kritéria kontroly kvality

20. září 2016

První zveřejněno (Odhad)

22. září 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. září 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. září 2022

Naposledy ověřeno

1. srpna 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB00101818

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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