Stress Reactivity Study in Adolescents

NCT03997149 | Completed

• 1 other identifier: HUM00078153
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Eating Behavior

Keywords

Trier Social Stress Test

Outcome Measures

Primary Outcomes (1)

• Food consumption

  Change in grams of each food consumed during the control and stress conditions were recorded and calories were calculated using the corresponding nutritional labels.

  2 hours

Secondary Outcomes (2)

• Salivary cortisol area under the curve

  2 hours

• Salivary alpha amylase area under the curve

  2 hours

Other Outcomes (2)

• Heart rate area under the curve

  2 hours

• Blood pressure area under the curve

  2 hours

Study Arms (2)

Stress Condition

EXPERIMENTAL

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

Rest Condition

PLACEBO COMPARATOR

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

Interventions

Acute Laboratory Stressor BEHAVIORAL

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.

Also known as: Trier Social Stress Test

Stress Condition

Low affect video BEHAVIORAL

The 20-minute TSST was replaced with a 20-minute low-affect educational film screening.

Rest Condition

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Overweight and obese adolescents ages 14- 19 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Childhood Disparities Research Laboratory

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Rebecca Hasson, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Childhood Disparities Research Laboratory

Model Details: Participants completed a stress condition and rest condition in random order.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 25, 2019
• Study Start: December 12, 2013
• Primary Completion: March 13, 2017
• Study Completion: April 30, 2017
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)