- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03997149
Stress Reactivity Study in Adolescents (SRAS)
24. juni 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- Childhood Disparities Research Laboratory
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Placebo komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Food consumption
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Salivary cortisol area under the curve
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Heart rate area under the curve
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Rebecca Hasson, PhD, University of Michigan
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. december 2013
Primær færdiggørelse (Faktiske)
13. marts 2017
Studieafslutning (Faktiske)
30. april 2017
Datoer for studieregistrering
Først indsendt
24. juni 2019
Først indsendt, der opfyldte QC-kriterier
24. juni 2019
Først opslået (Faktiske)
25. juni 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2019
Sidst verificeret
1. juni 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HUM00078153
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
Only de-identified participant data will be shared with other researchers during data analysis and manuscript preparation.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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