- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03997149
Stress Reactivity Study in Adolescents (SRAS)
24 juni 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- Childhood Disparities Research Laboratory
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
14 år till 19 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
Andra namn:
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Placebo-jämförare: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Food consumption
Tidsram: 2 hours
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Salivary cortisol area under the curve
Tidsram: 2 hours
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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
Tidsram: 2 hours
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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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Heart rate area under the curve
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Rebecca Hasson, PhD, University of Michigan
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 december 2013
Primärt slutförande (Faktisk)
13 mars 2017
Avslutad studie (Faktisk)
30 april 2017
Studieregistreringsdatum
Först inskickad
24 juni 2019
Först inskickad som uppfyllde QC-kriterierna
24 juni 2019
Första postat (Faktisk)
25 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- HUM00078153
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
Only de-identified participant data will be shared with other researchers during data analysis and manuscript preparation.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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