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Black Adolescent & Entertainment Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537755
Recruitment Status : Unknown
Verified May 2018 by Henry M. Jackson Foundation for the Advancement of Military Medicine.
Recruitment status was:  Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief Summary:
The study is being conducted to obtain adolescent girls' thoughts and opinions on relationship and communication styles are shown on television.

Condition or disease Intervention/treatment
Obesity, Childhood Other: Observation

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Effect of Food Marketing and Attentional Biases on Eating Behaviors in African American Adolescent Girls
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Observation
    Examine thoughts and behaviors


Primary Outcome Measures :
  1. Total energy consumption [ Time Frame: Day 1 ]
    Total energy consumption from a laboratory test meal

  2. Macronutrient intake [ Time Frame: Day 1 ]
    Total energy intake from fat, sugar, and sodium



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:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-reported female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Black/African American girls 12-17 years old
Criteria

Inclusion Criteria:

  1. Female,
  2. Self-identify as African American or Black,
  3. 12 to 17 years of age at the start of the study,
  4. Presence of obesity by virtue of a body mass index (BMI) ≥ 95th percentile for age and sex or non-overweight by virtue of a BMI of at least the5th percentile, but below the 85th percentile, for age and sex,118 and
  5. English speaking.

Exclusion Criteria:

  1. Reports of the presence of a major chronic medical illness: renal, hepatic, gastrointestinal, endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication),
  2. Individuals who self-report major depressive disorder, psychoses, current substance or alcohol use disorder, or any other psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.
  3. Current, regular use of prescription medications that affect appetite, mood, or body weight: currently prescribed serotonin re-uptake inhibitors (SSRIs), neuroleptics, tricyclics, stimulants, or any other medication known to affect appetite, mood, or body weight. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before the study visit,
  4. Failure to provide a rating of 6 or more on at least 50% of food items on the Food Preferences Questionnaire (Appendix F); exceptions may be given for restrictions due to religious practices or food allergies, if food items can be replaced with items of equivalent macronutrient content.

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 ClinicalTrials.gov identifier (NCT number): NCT03537755


Contacts
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Contact: Omni Cassidy, M.S. 301-295-0581 BAEStudy@usuhs.edu

Locations
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United States, Maryland
Uniformed Services University of the Health Sciences Recruiting
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Uniformed Services University of the Health Sciences
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT03537755    
Other Study ID Numbers: 1F31MD010675-01 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
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
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight