- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03997149
Stress Reactivity Study in Adolescents (SRAS)
24 juin 2019 mis à jour par: Rebecca Hasson, University of Michigan
Stress-induced Eating Behavior: Implications for Pediatric Obesity Disparities
The goal of this study was to examine the glucocorticoid and behavioral responses to a psychological stressor in obese African-American and non-Latino white adolescents.
Participants were exposed to the Trier Social Stress Test (TSST) and a control condition on separate days.
Immediately following each condition, participants were provided with snacks to eat at their leisure.
Reactivity was assessed via salivary cortisol and alpha-amylase area under the curve (AUC), and adolescents were categorized as high or low reactors.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
In the United States, pediatric obesity has more than tripled in the last 30 years, particularly among certain racial/ethnic groups including African-Americans.
This disparity is partially attributable to greater exposure to psychological stress reported in this group (relative to non-Latino whites).
Chronic psychological stress leads to weight gain directly through prolonged exposure to biological stress mediators such as cortisol and indirectly through behavioral pathways involving cortisol-induced increases in food consumption.
An exciting arena of scientific advancements is focusing on identifying the specific pathways through which chronic stress influences eating behavior with emerging evidence to suggest that food intake, which is commonly increased during periods of stress, may serve as one key mechanism linking stress and obesity, particularly in African-American youth who are disproportionately exposed to chronic stress and have greater access to, and consumption of, energy-dense palatable foods.
It is critical to advance understanding of the interplay between stress and food intake in understanding racial/ethnic disparities in pediatric obesity because stress eating represents a modifiable health behavior.
That is, increased food intake during periods of elevated stress can be targeted for intervention in ways that may ameliorate the deleterious effects of stress on obesity risk.
This project investigated the role of stress eating as a pathway linking chronic stress and obesity in African-American and non-Latino white adolescents.
Type d'étude
Interventionnel
Inscription (Réel)
60
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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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- Childhood Disparities Research Laboratory
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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
14 ans à 19 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Overweight and obese adolescents ages 14- 19 years
Exclusion Criteria:
- Currently pregnant
- Had been enrolled in a weight loss program in the last 6 months
- Were current smokers (e.g., tobacco, marijuana, vaping)
- Were diagnosed with a mental health condition (e.g, depression)
- Were diagnosed with a chronic condition known to affect weight, appetite, blood glucose or insulin levels (e.g., diabetes)
- Were taking medications known to affect metabolic processes (e.g., growth hormone, ritalin, metformin, etc)
- Had food allergies, intolerances, or other dietary restrictions
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: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Stress Condition
The stress condition involved the Trier Social Stress Test (TSST), a standardized laboratory stressor designed to elicit psychological stress and cortisol responses.
Following the TSST, participants were brought to a separate room, instructed to rest and given the option to eat at their leisure.
Books and magazines were included in the room for the participant to utilize.
|
The TSST was 20 minutes long and consisted of a five-minute instructional period where participants listened to a pre-recorded tape; a five-minute speech preparation period; a five-minute challenging serial subtraction task; and a five-minute videotaped public speaking task in front of a panel of three evaluative, non-affirming judges dressed in white coats.
Autres noms:
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Comparateur placebo: Rest Condition
Participants completed a control condition on a separate day.
This condition followed the same sequence of events as the stress condition with the exception that the 20-minute TSST was replaced with a 20-minute low-affect educational film screening.
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The 20-minute TSST was replaced with a 20-minute low-affect educational film screening.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Food consumption
Délai: 2 hours
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Change in grams of each food consumed during the control and stress conditions were recorded and calories were calculated using the corresponding nutritional labels.
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2 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Salivary cortisol area under the curve
Délai: 2 hours
|
During the control and stress conditions, saliva samples were taken at times 10, 25, 58, 88 and 118 minutes after arrival to analyze cortisol responses to the TSST.
Area under the curve was calculated from the initial cortisol sample collected to the final cortisol sample collected: [AUC=(x2+x1)/(t2-t1) + (x3+x2)/(t3-t2) + (xk+xj)/(tk-tj)].
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2 hours
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Salivary alpha amylase area under the curve
Délai: 2 hours
|
During the control and stress conditions, saliva samples were taken at times 10, 25, 58, 88 and 118 minutes after arrival to analyze alpha amylase responses to the TSST.
Area under the curve was calculated from the initial alpha-amylase sample collected to the final alpha amylase sample collected [AUC=(x2+x1)/(t2-t1) + (x3+x2)/(t3-t2) + (xk+xj)/(tk-tj)].
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2 hours
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart rate area under the curve
Délai: 2 hours
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Heart rate was taken throughout the control and stress conditions.
Area under the curve was calculated from the initial heart rate collected to the final heart rate sample collected [AUC=(x2+x1)/(t2-t1) + (x3+x2)/(t3-t2) + (xk+xj)/(tk-tj)].
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2 hours
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Blood pressure area under the curve
Délai: 2 hours
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Blood pressure was taken throughout the control and stress conditions.
Area under the curve was calculated from the initial blood pressure reading collected to the final blood pressure reading collected [AUC=(x2+x1)/(t2-t1) + (x3+x2)/(t3-t2) + (xk+xj)/(tk-tj)].
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2 hours
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Rebecca Hasson, PhD, University of Michigan
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)
12 décembre 2013
Achèvement primaire (Réel)
13 mars 2017
Achèvement de l'étude (Réel)
30 avril 2017
Dates d'inscription aux études
Première soumission
24 juin 2019
Première soumission répondant aux critères de contrôle qualité
24 juin 2019
Première publication (Réel)
25 juin 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HUM00078153
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Description du régime IPD
Only de-identified participant data will be shared with other researchers during data analysis and manuscript preparation.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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