- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03369691
Ethnic Influences on Stress, Energy Balance and Obesity in Adolescents
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Larissa Chau, BS
- Phone Number: 949-824-3657
- Email: lychau@uci.edu
Study Locations
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-
California
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Irvine, California, United States, 92617
- Recruiting
- Universty of California, Irvine
-
Contact:
- Larissa Chau, BS
- Phone Number: 949-824-3657
- Email: lychau@uci.edu
-
Principal Investigator:
- Uma Rao, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days between the two sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index (BMI)
Time Frame: 1 hour
|
Weight (kg) and height (inches) will be used to determine BMI in kg/cm^2
|
1 hour
|
Physical activity energy expenditure
Time Frame: 7 days
|
Average moderate and vigorous activity (minutes) will be recorded through the Actigraph device
|
7 days
|
Visceral fat percent
Time Frame: 1 hour
|
Amount of visceral fat (percent of total fat) will be determined by dual-energy x-ray scan
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Uma Rao, MD, University of California, Irvine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20173441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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