NCT03369691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

December 16, 2017

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

8.2 years

First QC Date

December 1, 2017

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days between the two sessions

Secondary Outcomes (3)

  • Body mass index (BMI)

    1 hour

  • Physical activity energy expenditure

    7 days

  • Visceral fat percent

    1 hour

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universty of California, Irvine

Irvine, California, 92617, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva, serum, plasma and hair

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Uma Rao, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 12, 2017

Study Start

December 16, 2017

Primary Completion

February 7, 2026

Study Completion

February 7, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations