Obesity, ChildhoodNCT03537755
Black Adolescent & Entertainment Study
An observational study of Obesity, Childhood, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The study is being conducted to obtain adolescent girls' thoughts and opinions on relationship and communication styles are shown on television. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Observation
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Black/African American girls 12-17 years old
Who may be able to join
- Female,
- Self-identify as African American or Black,
- 12 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
About this study
Official title: The Effect of Food Marketing and Attentional Biases on Eating Behaviors in African American Adolescent Girls
The study is being conducted to obtain adolescent girls' thoughts and opinions on relationship and communication styles are shown on television.
- Conditions
- Obesity, Childhood
- Being tested
- Observation
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Examine thoughts and behaviors
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy consumption
Total energy consumption from a laboratory test meal
Measured: Day 1
Macronutrient intake
Total energy intake from fat, sugar, and sodium
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start6 Jun 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537755
- Sponsor's protocol ID
- 1F31MD010675-01
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Marketing and Attentional Biases on Eating Behaviors in African American Adolescent Girls
- ClinicalTrials.gov ID
- NCT03537755
- Acronym / sponsor ID
- 1F31MD010675-01
- Conditions
- Obesity, Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Uniformed Services University of the Health Sciences
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to obtain adolescent girls' thoughts and opinions on relationship and communication styles are shown on television.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Black/African American girls 12-17 years old
Key inclusion criteria (5 listed)
- Female,
- Self-identify as African American or Black,
- 12 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationExamine thoughts and behaviors | Other | – |
Primary outcome
Total energy consumption
Time frame: Day 1
Total energy consumption from a laboratory test meal
Macronutrient intake
Time frame: Day 1
Total energy intake from fat, sugar, and sodium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omni Cassidy, M.S. (301-295-0581, BAEStudy@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy consumption (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.