NHANES 2003-2014 and Sugar-sweetened Beverages in Children | NCT03361943

Studies
NHANES 2003-2014 and Sugar-sweetened Beverages in Children

NCT03361943

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Dec 6, 2017Actual

Enrollment

17,579Actual

Phase

Not provided

Conditions

Sugar Sweetened Beverage Intakes in US Children

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2003Actual

Primary Completion Date

Dec 31, 2014Actual

Completion Date

Dec 31, 2014Actual

First Submitted Date

Nov 29, 2017

First Submission Date that Met QC Criteria

Nov 29, 2017

First Posted Date

Dec 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2017

Last Update Posted Date

Dec 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michelle Mendez, Visiting Associate Professor, University of PittsburghPrincipal Investigator

Lead Sponsor

University of PittsburghOTHER

Collaborators

Name	Class
University of North Carolina, Chapel Hill	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17,579Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	2003-2014

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All U.S. children aged 2-18y in US NHANES diet surveys from 2003-2014

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

17,579 children aged 2-18 years in US NHANES dietary surveys from 2003-2014 with household socioeconomic data

Sampling Method

Probability Sample