Black Adolescent & Entertainment Study

Obesity, Childhood Clinical Trial

Official title:

The Effect of Food Marketing and Attentional Biases on Eating Behaviors in African American Adolescent Girls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03537755
• Other study ID #: 1F31MD010675-01
• Status: Recruiting
• Start date: June 6, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2018
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: Omni Cassidy, M.S.
• Phone: 301-295-0581
• Email: BAEStudy[@]usuhs.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• Observation
Examine thoughts and behaviors

Locations

Country	Name	City	State
United States	Uniformed Services University of the Health Sciences	Bethesda	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total energy consumption	Total energy consumption from a laboratory test meal	Day 1
Primary	Macronutrient intake	Total energy intake from fat, sugar, and sodium	Day 1