Obesity, AdolescentNCT03369691
Ethnic Influences on Stress, Energy Balance and Obesity in Adolescents
An observational study of Obesity, Adolescent and Stress, run by University of California, Irvine at 1 site in United States.
Trial summary
The study will examine the mechanisms linking race, stress and biobehavioral factors to energy balance and obesity in both natural and controlled environments in African-American and Caucasian adolescent females. A Hispanic/Latina cohort has recently been added with permission for the sponsor. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Stress, Physical Activity
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2017to 7 Feb 2026
- Phase
- Observational
- 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 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Community sample
Who may be able to join
- African-American, Hispanic, Non-Hispanic White females from 13-17 years old and Tanner Stage ≥III.
- BMI values will be balanced (1/3rd normal, 1/3rd overweight and 1/3rd obese range percentile BMI values) using Center for Disease Control criteria
Who cannot join
- Participants with a BMI below the normal range, trying to lose weight, on medications that affect appetite or hypothalamic-pituitary-adrenal axis, or with a history of bariatric surgery, will be excluded.
- Restrained or binge eaters, individuals who score below 50 on a 100 mm Visual Analog Scale for foods provided in the study, or those allergic to these foods will be excluded.
- Participants with major psychiatric disorders (e.g., anxiety, eating, mood, substance use disorders) or medical problems (e.g., endocrine disorders or unstable cardiac, pulmonary or renal conditions) will be excluded.
- Pregnant females, or those suspected of being pregnant, will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Universty of California, Irvine
Irvine, California, 92617
About this study
The study will examine the mechanisms linking race, stress and biobehavioral factors to energy balance and obesity in both natural and controlled environments in African-American and Caucasian adolescent females. A Hispanic/Latina cohort has recently been added with permission for the sponsor.
Read the detailed description
Obesity is one of the most serious public health problems in the US; its prevalence has tripled in the last three decades and is associated with a range of short- and long-term medical and psychosocial problems. Adolescence is a critical period for the development and persistence of obesity, and is associated with changes in diet, physical activity and fitness, fat distribution and insulin sensitivity. There are racial and sex-specific disparities in the prevalence and burden of obesity. African-American (AA) females have the highest rates of obesity, and the clustered risk factors for coronary heart disease and metabolic syndrome are twice that of AA males. The reasons for racial and sex-specific disparities in the prevalence and burden of obesity are not well understood. AA experience higher stress levels than Non-Hispanic Whites (NHW) due to economic and social inequalities, and the effect of stress on energy-dense diet and adiposity is more prominent in females. A better understanding of the mechanisms that link stress to obesity, particularly during adolescence when high rates of obesity, increased stressful experiences and stronger behavioral and physiological responses to stress emerge, will contribute to new clinical guidelines for reducing obesity and associated medical conditions in AA females.
The Physiological stress system affects obesity and mediates its adaptive functions via hypothalamic-pituitary-adrenal (HPA) axis. Prolonged stress-induced glucocorticoid secretion promotes the consumption of energy-dense diet (EI) and abdominal fat deposition both directly and indirectly through its effects on metabolic hormones. Stress also reduces physical activity and alters energy balance. The proposed study will examine the effects of stress and HPA axis on EI and physical activity-related energy expenditure in 100 AA and 100 NHW adolescent females. The effects on EI will be assessed in two contexts, the natural environment and under controlled conditions incorporating a standardized psychosocial stressor. Stress will be assessed in the natural environment as multiple domains (i.e., individual, family and social), and several indices of the HPA axis will be obtained to represent diurnal variation, its status over 12-15 weeks and reactivity to stress. Obesity-related parameters will be measured through anthropometry, fat distribution and cardio-metabolic biomarkers.
Associations among stress, HPA activity/function, energy balance and obesity-related parameters will be compared between and within AA and NHW samples. In combination they will improve our understanding of the social factors and biobehavioral mechanisms of both racial and individual differences in obesity and facilitate the development of effective treatments within and across racial groups according to the principles of individualized medicine. To our knowledge, racial differences in objectively-measured diet intake and energy expenditure in response to stress, or their underlying physiological mechanisms, have not been assessed in adolescents or adults. This is an important knowledge gap in our efforts to develop better evidence-based translational obesity prevention and weight-control interventions as the traditional interventions are not effective with minority youth.
- Conditions
- Obesity, Adolescent, Stress, Physical Activity
- Medical subject headings
- Pediatric Obesity, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of food intake from buffet lunch after the control and stress sessions
Randomize lab session to assign each participant to a non-stress or stress condition, and reversed in the next session. Ad-libitum food intake (amount of added sugar and solid fat) during both sessions will be measured and compared.
Measured: 7 days between the two sessions
Secondary outcomes (3)
Body mass index (BMI)
Weight (kg) and height (inches) will be used to determine BMI in kg/cm^2
Measured: 1 hour
Physical activity energy expenditure
Average moderate and vigorous activity (minutes) will be recorded through the Actigraph device
Measured: 7 days
Visceral fat percent
Amount of visceral fat (percent of total fat) will be determined by dual-energy x-ray scan
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start16 Dec 2017
- Primary completion7 Feb 2026
- Study completion7 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uma Rao, University of California, Irvine
- Investigators
- Uma Rao, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369691
- Sponsor's protocol ID
- 20173441
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2017
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Influences on Stress, Energy Balance and Obesity in Adolescents
- ClinicalTrials.gov ID
- NCT03369691
- Acronym / sponsor ID
- 20173441
- Conditions
- Obesity, Adolescent, Stress, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 16 Dec 2017 (actual)
- Primary completion
- 7 Feb 2026 (actual)
- Study completion
- 7 Feb 2026 (actual)
- First posted
- 12 Dec 2017 (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 study will examine the mechanisms linking race, stress and biobehavioral factors to energy balance and obesity in both natural and controlled environments in African-American and Caucasian adolescent females. A Hispanic/Latina cohort has recently been added with permission for the sponsor.
Detailed description
Obesity is one of the most serious public health problems in the US; its prevalence has tripled in the last three decades and is associated with a range of short- and long-term medical and psychosocial problems. Adolescence is a critical period for the development and persistence of obesity, and is associated with changes in diet, physical activity and fitness, fat distribution and insulin sensitivity. There are racial and sex-specific disparities in the prevalence and burden of obesity. African-American (AA) females have the highest rates of obesity, and the clustered risk factors for coronary heart disease and metabolic syndrome are twice that of AA males. The reasons for racial and sex-specific disparities in the prevalence and burden of obesity are not well understood. AA experience higher stress levels than Non-Hispanic Whites (NHW) due to economic and social inequalities, and the effect of stress on energy-dense diet and adiposity is more prominent in females. A better understanding of the mechanisms that link stress to obesity, particularly during adolescence when high rates of obesity, increased stressful experiences and stronger behavioral and physiological responses to stress emerge, will contribute to new clinical guidelines for reducing obesity and associated medical conditions in AA females.
The Physiological stress system affects obesity and mediates its adaptive functions via hypothalamic-pituitary-adrenal (HPA) axis. Prolonged stress-induced glucocorticoid secretion promotes the consumption of energy-dense diet (EI) and abdominal fat deposition both directly and indirectly through its effects on metabolic hormones. Stress also reduces physical activity and alters energy balance. The proposed study will examine the effects of stress and HPA axis on EI and physical activity-related energy expenditure in 100 AA and 100 NHW adolescent females. The effects on EI will be assessed in two contexts, the natural environment and under controlled conditions incorporating a standardized psychosocial stressor. Stress will be assessed in the natural environment as multiple domains (i.e., individual, family and social), and several indices of the HPA axis will be obtained to represent diurnal variation, its status over 12-15 weeks and reactivity to stress. Obesity-related parameters will be measured through anthropometry, fat distribution and cardio-metabolic biomarkers.
Associations among stress, HPA activity/function, energy balance and obesity-related parameters will be compared between and within AA and NHW samples. In combination they will improve our understanding of the social factors and biobehavioral mechanisms of both racial and individual differences in obesity and facilitate the development of effective treatments within and across racial groups according to the principles of individualized medicine. To our knowledge, racial differences in objectively-measured diet intake and energy expenditure in response to stress, or their underlying physiological mechanisms, have not been assessed in adolescents or adults. This is an important knowledge gap in our efforts to develop better evidence-based translational obesity prevention and weight-control interventions as the traditional interventions are not effective with minority youth.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample
Key inclusion criteria (2 listed)
- African-American, Hispanic, Non-Hispanic White females from 13-17 years old and Tanner Stage ≥III.
- BMI values will be balanced (1/3rd normal, 1/3rd overweight and 1/3rd obese range percentile BMI values) using Center for Disease Control criteria
Key exclusion criteria (4 listed)
- Participants with a BMI below the normal range, trying to lose weight, on medications that affect appetite or hypothalamic-pituitary-adrenal axis, or with a history of bariatric surgery, will be excluded.
- Restrained or binge eaters, individuals who score below 50 on a 100 mm Visual Analog Scale for foods provided in the study, or those allergic to these foods will be excluded.
- Participants with major psychiatric disorders (e.g., anxiety, eating, mood, substance use disorders) or medical problems (e.g., endocrine disorders or unstable cardiac, pulmonary or renal conditions) will be excluded.
- Pregnant females, or those suspected of being pregnant, will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of food intake from buffet lunch after the control and stress sessions
Time frame: 7 days between the two sessions
Randomize lab session to assign each participant to a non-stress or stress condition, and reversed in the next session. Ad-libitum food intake (amount of added sugar and solid fat) during both sessions will be measured and compared.
3 secondary outcomes
Body mass index (BMI)
Time frame: 1 hour
Physical activity energy expenditure
Time frame: 7 days
Visceral fat percent
Time frame: 1 hour
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 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Uma Rao, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Adolescent and Stress, run by University of California, Irvine 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 2 inclusion and 4 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 13 Mar 2026. 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. 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?
Comparison of food intake from buffet lunch after the control and stress sessions (time frame: 7 days between the two sessions). 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 13 Mar 2026.