Black Adolescent & Entertainment Study

NCT03537755 | Unknown

• 1 other identifier: 1F31MD010675-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

• Total energy consumption

  Total energy consumption from a laboratory test meal

  Day 1

• Macronutrient intake

  Total energy intake from fat, sugar, and sodium

  Day 1

Interventions

Observation OTHER

Examine thoughts and behaviors

Eligibility Criteria

• Age: 12 Years - 17 Years
• Gender Eligibility Details: Self-reported female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Black/African American girls 12-17 years old

You may qualify if:

• Female,
• Self-identify as African American or Black,
• to 17 years of age at the start of the study,
• 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
• English speaking.

You may not qualify if:

• 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),
• 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.
• 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,
• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Observation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Omni Cassidy, M.S.

CONTACT

301-295-0581; BAEStudy@usuhs.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 25, 2018
• Study Start: June 6, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)