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Ethnic Influences on Stress, Energy Balance and Obesity in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03369691
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : April 7, 2022
Information provided by (Responsible Party):
Uma Rao, University of California, Irvine

Brief 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.

Condition or disease
Obesity, Adolescent Stress Physical Activity

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Ethnic Influences on Stress, Energy Balance and Obesity in Adolescents
Actual Study Start Date : December 16, 2017
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: 1 hour ]
    Weight (kg) and height (inches) will be used to determine BMI in kg/cm^2

  2. Physical activity energy expenditure [ Time Frame: 7 days ]
    Average moderate and vigorous activity (minutes) will be recorded through the Actigraph device

  3. Visceral fat percent [ Time Frame: 1 hour ]
    Amount of visceral fat (percent of total fat) will be determined by dual-energy x-ray scan

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample

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.

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 identifier (NCT number): NCT03369691

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Contact: Larissa Chau, BS 949-824-3657

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United States, California
Universty of California, Irvine Recruiting
Irvine, California, United States, 92617
Contact: Larissa Chau, BS    949-824-3657   
Principal Investigator: Uma Rao, MD         
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Uma Rao, MD University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Uma Rao, University of California, Irvine:
Informed Consent Form  [PDF] March 4, 2021

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Responsible Party: Uma Rao, Professor and Vice Chair, University of California, Irvine Identifier: NCT03369691    
Other Study ID Numbers: 2017-3441
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight