Sugar Sweetened Beverage Intakes in US ChildrenNCT03361943
NHANES 2003-2014 and Sugar-sweetened Beverages in Children
An observational study of Sugar Sweetened Beverage Intakes in US Children, run by University of Pittsburgh.
Trial summary
The study uses data from the NHANES surveys to evaluate trends in SSB intakes among US children. The goal was to determine whether recent declines in intake may have been less marked in the more vulnerable groups with a persistently high burden of obesity, including race/ethnic minorities and low-income groups. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sugar Sweetened Beverage Intakes in US Children
- How many people
- 17,579 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 31 Dec 2014
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 17,579 children aged 2-18 years in US NHANES dietary surveys from 2003-2014 with household socioeconomic data
Who may be able to join
- All U.S. children aged 2-18y in US NHANES diet surveys from 2003-2014
Who cannot join
- missing socio-economic data: parental education or household income as a percentage of the Federal Poverty Level; n=1841
- missing or implausible dietary data, defined as: energy intake of zero kcal or more than four standard deviations beyond individual estimated energy requirements, or no report on whether data represents usual intake (more, same or less than usual); n=236
About this study
Official title: Analysis of National Health and Nutrition Examination Survey (NHANES) 2003-2014 Data to Evaluate Trends in Sugar-sweetened Beverage (SSB) Intakes in Children
The study uses data from the NHANES surveys to evaluate trends in SSB intakes among US children. The goal was to determine whether recent declines in intake may have been less marked in the more vulnerable groups with a persistently high burden of obesity, including race/ethnic minorities and low-income groups.
Read the detailed description
Recent studies suggest sugar-sweetened beverage (SSB) consumption has been declining among US children 2-18y. However, most studies focus on changes in mean intake and little is known about trends in the high SSB consumers who are most at risk of excess weight gain. There is also limited understanding of whether and how these changes over time may have influenced disparities in intake among vulnerable groups of children with persistently high levels of obesity, including children from low-income households, and several race-/ethnic minorities.
This analysis of six cycles of US National Health and Nutrition Examination Survey (NHANES) dietary surveillance data from 2003-2014 examined shifts over time in SSB intake at both the median and 90th percentile among US children. The study evaluated the extent to which disparities in intake of total SSBs, as well as major SSB subtypes (regular sodas, fruit drinks and other), may have persisted in vulnerable groups, for both median and "heavy" intake. The analysis presents data for three age groups: 2-5y, 6-11y and 12-18y by gender, and focus on three race-ethnic groups: Non-Hispanic White, Non-Hispanic Black, and Mexican-American. Household income is used as the primary socioeconomic status variable.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugar Sweetened Beverage Intake in Children
All non-alcoholic, non-diet beverages sweetened with sugars of any type, either as purchased or added after purchase
Measured: 2003-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jan 2003
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sugar Sweetened Beverage Intakes in US ChildrenStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 17,579 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Michelle Mendez, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361943
- Sponsor's protocol ID
- mendezssb1
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of National Health and Nutrition Examination Survey (NHANES) 2003-2014 Data to Evaluate Trends in Sugar-sweetened Beverage (SSB) Intakes in Children
- ClinicalTrials.gov ID
- NCT03361943
- Acronym / sponsor ID
- mendezssb1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,579 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 5 Dec 2017 (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 uses data from the NHANES surveys to evaluate trends in SSB intakes among US children. The goal was to determine whether recent declines in intake may have been less marked in the more vulnerable groups with a persistently high burden of obesity, including race/ethnic minorities and low-income groups.
Detailed description
Recent studies suggest sugar-sweetened beverage (SSB) consumption has been declining among US children 2-18y. However, most studies focus on changes in mean intake and little is known about trends in the high SSB consumers who are most at risk of excess weight gain. There is also limited understanding of whether and how these changes over time may have influenced disparities in intake among vulnerable groups of children with persistently high levels of obesity, including children from low-income households, and several race-/ethnic minorities.
This analysis of six cycles of US National Health and Nutrition Examination Survey (NHANES) dietary surveillance data from 2003-2014 examined shifts over time in SSB intake at both the median and 90th percentile among US children. The study evaluated the extent to which disparities in intake of total SSBs, as well as major SSB subtypes (regular sodas, fruit drinks and other), may have persisted in vulnerable groups, for both median and "heavy" intake. The analysis presents data for three age groups: 2-5y, 6-11y and 12-18y by gender, and focus on three race-ethnic groups: Non-Hispanic White, Non-Hispanic Black, and Mexican-American. Household income is used as the primary socioeconomic status variable.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 17,579 children aged 2-18 years in US NHANES dietary surveys from 2003-2014 with household socioeconomic data
Key inclusion criteria (1 listed)
- All U.S. children aged 2-18y in US NHANES diet surveys from 2003-2014
Key exclusion criteria (2 listed)
- missing socio-economic data: parental education or household income as a percentage of the Federal Poverty Level; n=1841
- missing or implausible dietary data, defined as: energy intake of zero kcal or more than four standard deviations beyond individual estimated energy requirements, or no report on whether data represents usual intake (more, same or less than usual); n=236
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sugar Sweetened Beverage Intake in Children
Time frame: 2003-2014
All non-alcoholic, non-diet beverages sweetened with sugars of any type, either as purchased or added after purchase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sugar Sweetened Beverage Intakes in US Children, run by University of Pittsburgh.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sugar Sweetened Beverage Intake in Children (time frame: 2003-2014). 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 6 Dec 2017.