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Stress Reactivity Study in Adolescents (SRAS)

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ClinicalTrials.gov Identifier: NCT03997149
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Rebecca Hasson, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Eating Behavior Behavioral: Acute Laboratory Stressor Behavioral: Low affect video Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Participants completed a stress condition and rest condition in random order.
Masking: Single (Participant)
Masking Description: Immediately following each condition, participants were provided with snacks to eat at their leisure. Participants were not told that their post-condition food consumption would be measured and was part of the research study.
Primary Purpose: Diagnostic
Official Title: Stress-induced Eating Behavior: Implications for Pediatric Obesity Disparities
Actual Study Start Date : December 12, 2013
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : April 30, 2017

Arm Intervention/treatment
Experimental: 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.
Behavioral: Acute Laboratory Stressor
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.
Other Name: Trier Social Stress Test

Placebo Comparator: 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.
Behavioral: Low affect video
The 20-minute TSST was replaced with a 20-minute low-affect educational film screening.




Primary Outcome Measures :
  1. Food consumption [ Time Frame: 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.


Secondary Outcome Measures :
  1. Salivary cortisol area under the curve [ Time Frame: 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)].

  2. Salivary alpha amylase area under the curve [ Time Frame: 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)].


Other Outcome Measures:
  1. Heart rate area under the curve [ Time Frame: 2 hours ]
    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)].

  2. Blood pressure area under the curve [ Time Frame: 2 hours ]
    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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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997149


Locations
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United States, Michigan
Childhood Disparities Research Laboratory
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Rebecca Hasson, PhD University of Michigan

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Responsible Party: Rebecca Hasson, Director, Childhood Disparities Research Laboratory, University of Michigan
ClinicalTrials.gov Identifier: NCT03997149     History of Changes
Other Study ID Numbers: HUM00078153
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only de-identified participant data will be shared with other researchers during data analysis and manuscript preparation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Hasson, University of Michigan:
Trier Social Stress Test