StressSRASNCT03997149
Stress Reactivity Study in Adolescents
A study testing Acute Laboratory Stressor and Low affect video in people with Stress and Eating Behavior, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Eating Behavior
- What is being tested?
- Acute Laboratory Stressor and Low affect video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2013to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Overweight and obese adolescents ages 14- 19 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Childhood Disparities Research Laboratory
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Eating Behavior
- Being tested
- Acute Laboratory Stressor, Low affect video
- Keywords
- Trier Social Stress Test
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Laboratory StressorBehavioural
Also called Trier Social Stress Test
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.
Low affect videoBehavioural
The 20-minute TSST was replaced with a 20-minute low-affect educational film screening.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Low affect video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (2)
Salivary cortisol area under the curve
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)].
Measured: 2 hours
Salivary alpha amylase area under the curve
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)].
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start12 Dec 2013
- Primary completion13 Mar 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants completed a stress condition and rest condition in random order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Hasson, University of Michigan
- Investigators
- Rebecca Hasson, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997149
- Sponsor's protocol ID
- HUM00078153
- Acronym
- SRAS
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified participant data will be shared with other researchers during data analysis and manuscript preparation.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-induced Eating Behavior: Implications for Pediatric Obesity Disparities
- ClinicalTrials.gov ID
- NCT03997149
- Acronym / sponsor ID
- SRAS / HUM00078153
- Conditions
- Stress, Eating Behavior
- Keywords
- Trier Social Stress Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Dec 2013 (actual)
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants completed a stress condition and rest condition in random order.
| Arm | Type | Receives |
|---|---|---|
| Stress Condition | Experimental | Behavioral: Acute Laboratory StressorThe 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. |
| Rest Condition | Placebo comparator | Behavioral: Low affect videoParticipants 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Overweight and obese adolescents ages 14- 19 years
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Laboratory StressorAlso: Trier Social Stress TestThe 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. | Behavioural | Stress Condition |
| Low affect videoThe 20-minute TSST was replaced with a 20-minute low-affect educational film screening. | Behavioural | Rest Condition |
Primary outcome
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.
2 secondary outcomes
Salivary cortisol area under the curve
Time frame: 2 hours
Salivary alpha amylase area under the curve
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No. Only de-identified participant data will be shared with other researchers during data analysis and manuscript preparation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Hasson, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Laboratory Stressor and Low affect video in people with Stress and Eating Behavior, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food consumption (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.