Overweight and ObesityNCT03261882
Loss of a Healthy Weight Advantage Among Mexican-American Children
An observational study of Overweight and Obesity, run by University of North Carolina, Chapel Hill.
Trial summary
Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be changing over time. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Nativity
- How many people
- 11,987 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Jul 2017
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Data came from the National Health and Nutrition Examination Surveys (NHANES), a series of repeated cross-sectional surveys conducted by the U.S. Centers for Disease Control and Prevention. The investigators used data from NHANES III (1988-1994) and 5 pooled survey cycles from the continuous NHANES (2005-2014) to represent the two survey periods under study over 20 years apart. These analyses were restricted to Mexican-Americans and non-Hispanic White children aged 4-17 years. Out of the 12,006 Mexican-Americans and white children who attended the clinical examination in NHANES III and the continuous NHANES (2005-2014), those who reported being pregnant were excluded from analyses (N=19). Our final analytic sample included 6,280 Mexican-Americans and 5,707 White children across the two survey periods (2,704 Mexican-Americans and 2,014 White children in 1988-1994; 3,576 Mexican-Americans and 3,693 White children in 2005-2014)
Who may be able to join
- Mexican-Americans and white children who attended the clinical examination in NHANES III and the continuous NHANES
Who cannot join
- Reported being pregnant
About this study
Official title: Loss of a Healthy Weight Advantage Among Foreign-born Children of Mexican Origin: Analysis of Overweight/Obesity Trends From 1988-1994 to 2005-2014
Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be changing over time. The objective of this study was to examine whether the relationship between nativity and overweight/obesity has changed over time among Mexican-American children and to investigate the implications of this pattern on overweight/obesity disparities relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and non-Hispanic white children ages 4-17 years participating in the National Health and Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by nativity status adjusting for age, sex, householder marital status, householder education, survey period and a nativity by survey period interaction. The investigators also tested another covariate-adjusted model with a 3-level ethnicity-nativity variable that included Whites and an ethnicity-nativity by survey period interaction.
- Conditions
- Overweight and Obesity
- Being tested
- Nativity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NativityOther
Mexican-American children were subdivided into two groups based on their country of birth. Mexican-American children who were not born in the U.S. were considered foreign-born and those born in the U.S. were U.S.-born.
| Study group | Role | What they receive |
|---|---|---|
| Foreign-born Mexican-Americans | Not described Receives: Other: Nativity | |
| US-born Mexican-Americans | Not described Receives: Other: Nativity | |
| non-Hispanic Whites | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overweight/obesity
Body mass index (BMI) was calculated by dividing weight (kg) by height2 (m2), and overweight/obesity was defined as a BMI at or above the age- and sex-specific 85th percentile based on the CDC's BMI-for-age growth charts (yes/no).
Measured: 1988-1994 and 2005-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Jun 2016
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Cross-sectional
- Enrolment
- 11,987 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261882
- Sponsor's protocol ID
- NHANES
- Other IDs
- 1T32HL129969-01A1, R24HD050924, K01DK107791
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- 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 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loss of a Healthy Weight Advantage Among Foreign-born Children of Mexican Origin: Analysis of Overweight/Obesity Trends From 1988-1994 to 2005-2014
- ClinicalTrials.gov ID
- NCT03261882
- Acronym / sponsor ID
- NHANES
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,987 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 25 Aug 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.
Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be changing over time. The objective of this study was to examine whether the relationship between nativity and overweight/obesity has changed over time among Mexican-American children and to investigate the implications of this pattern on overweight/obesity disparities relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and non-Hispanic white children ages 4-17 years participating in the National Health and Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by nativity status adjusting for age, sex, householder marital status, householder education, survey period and a nativity by survey period interaction. The investigators also tested another covariate-adjusted model with a 3-level ethnicity-nativity variable that included Whites and an ethnicity-nativity by survey period interaction.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foreign-born Mexican-Americans | – | Other: Nativity |
| US-born Mexican-Americans | – | Other: Nativity |
| non-Hispanic Whites | – | – |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Data came from the National Health and Nutrition Examination Surveys (NHANES), a series of repeated cross-sectional surveys conducted by the U.S. Centers for Disease Control and Prevention. The investigators used data from NHANES III (1988-1994) and 5 pooled survey cycles from the continuous NHANES (2005-2014) to represent the two survey periods under study over 20 years apart. These analyses were restricted to Mexican-Americans and non-Hispanic White children aged 4-17 years. Out of the 12,006 Mexican-Americans and white children who attended the clinical examination in NHANES III and the continuous NHANES (2005-2014), those who reported being pregnant were excluded from analyses (N=19). Our final analytic sample included 6,280 Mexican-Americans and 5,707 White children across the two survey periods (2,704 Mexican-Americans and 2,014 White children in 1988-1994; 3,576 Mexican-Americans and 3,693 White children in 2005-2014)
Key inclusion criteria (1 listed)
- Mexican-Americans and white children who attended the clinical examination in NHANES III and the continuous NHANES
Key exclusion criteria (1 listed)
- Reported being pregnant
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 |
|---|---|---|
| NativityMexican-American children were subdivided into two groups based on their country of birth. Mexican-American children who were not born in the U.S. were considered foreign-born and those born in the U.S. were U.S.-born. | Other | Foreign-born Mexican-Americans, US-born Mexican-Americans |
Primary outcome
overweight/obesity
Time frame: 1988-1994 and 2005-2014
Body mass index (BMI) was calculated by dividing weight (kg) by height2 (m2), and overweight/obesity was defined as a BMI at or above the age- and sex-specific 85th percentile based on the CDC's BMI-for-age growth charts (yes/no).
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 25 Aug 2017.
- 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.
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 Overweight and Obesity, run by University of North Carolina, Chapel Hill.
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 1 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 25 Aug 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?
overweight/obesity (time frame: 1988-1994 and 2005-2014). 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 25 Aug 2017.