Diet HabitNCT03266497
Diet Quality Among U.S.-Born and Foreign-born Non-Hispanic Blacks
An observational study of Diet Habit, run by Sara C. Folta.
Trial summary
This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks using pooled NHANES data. Read more about this study
- Who is it for?
- Ages 22 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- How many people
- 4,243 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2012
- 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 22 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprised 4,243 non-Hispanic Blacks, including 3,837 U.S.-born (90.4%) and 406 foreign-born (9.6%). Compared to U.S.-born Blacks, a higher proportion of foreign-born Blacks were male, had attained a higher level of education, were classified as normal or overweight, had never been a smoker, engaged in physical activity, and had lower energy intake. In comparison to those who were in the U.S. for <10 years, more foreign-born Blacks who were in the U.S. for ≥30 years were current smokers (14.8% vs. 5.0%, respectively), had higher income (IPR of ≥4.00: 43.5% vs 7.9%, respectively), and a higher percent with a college degree or higher (39.4% vs. 18.3%, respectively). Foreign-born Blacks residing in the U.S. for ≥30 years reported higher BMI in comparison to those residing in the U.S. for <10 years (28.8 vs. 26.7 kg/m2).
Who may be able to join
- 22-79
Who cannot join
- Pregnant subjects
- Energy intakes of ≤600 kcal and ≥ 4800 kcal
- No dietary data available
About this study
Official title: Diet Quality Among U.S.-Born and Foreign-born Non-Hispanic Blacks: NHANES 2003-2012 Data
This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks using pooled NHANES data.
Read the detailed description
This study uses the Alternative Healthy Eating Index-2010 (AHEI-2010) and Dietary Approach to Stop Hypertension (DASH) scores to compare diet quality between U.S.-born (n=3,837) and foreign-born (n=406) non-Hispanic Black adults aged 22-79y, based on pooled nationally representative data (NHANES 2003-2012); as well as by length of U.S. residency. Association between nativity and diet quality was done using multivariable-adjusted linear regression for the continuous total diet quality scores and their components, or multinomial (polytomous) logistic regression for categorical tertiles (low, medium, or high) of the total scores and their components. The study found that foreign-born Blacks had significantly higher AHEI-2010 and DASH scores compared to U.S-born Blacks, and more favorable intakes for many of the score components. Among foreign-born Blacks, diet quality did not significantly differ by length of residency. Foreign-born Blacks were more likely to be in the high than low tertile for fruit (including and excluding fruit juice), vegetables (excluding starchy vegetables), percent whole grains, and omega-3 fatty acids. Overall, the study suggests that foreign-born Blacks have better diet quality compared to their U.S.-born counterparts. Considering nativity among U.S. Blacks in nutrition research and public health efforts may therefore improve accuracy of characterizing dietary intakes and facilitate development of targeted nutrition interventions to reduce diet-related diseases in the diverse Black population in the U.S.
- Conditions
- Diet Habit
- Keywords
- diet quality, health disparities, immigrants, foreign-born, Blacks/African Americans, place of birth/nativity, length of residency, NHANES, acculturation
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted AHEI-2010
Components include: fruit (excluding fruit juice) (s/d); vegetables (excluding white potatoes) (s/d); whole grains (oz-equivalents/d); sugar-sweetened beverages (s/d); nuts, legumes, and vegetable protein (oz-equivalents/d); red/processed meat (s/d); long-chain omega-3 fats (EPA+DHA; mg/d); polyunsaturated fats (PUFA; % kcal/d); sodium (mg/d); and alcohol (drinks/d). Potential range of 0-100 points and higher scores indicative of higher diet quality
Measured: 2003-2012
Secondary outcomes (1)
Adapted DASH score
Quintile-, food-based dietary score assessing adherence to the DASH diet, which was developed as a dietary approach to prevent and treat hypertension. Components of the revised score include vegetables, fruit, whole grains, nuts and legumes, sodium, red and processed meat, and sugar-sweetened beverages.
Measured: 2003-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study startJan 2003
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara C. Folta
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Albert Einstein College of Medicine
- Responsible party
- Sponsor-investigator, Sara C. Folta, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266497
- Sponsor's protocol ID
- R01HL115189
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 30 Aug 2017
- 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 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Quality Among U.S.-Born and Foreign-born Non-Hispanic Blacks: NHANES 2003-2012 Data
- ClinicalTrials.gov ID
- NCT03266497
- Acronym / sponsor ID
- R01HL115189
- Conditions
- Diet Habit
- Keywords
- diet quality, health disparities, immigrants, foreign-born, Blacks/African Americans, place of birth/nativity, length of residency, NHANES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,243 participants (actual)
- Lead sponsor
- Sara C. FoltaUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Albert Einstein College of Medicine
- Study start
- Jan 2003 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 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.
This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks using pooled NHANES data.
Detailed description
This study uses the Alternative Healthy Eating Index-2010 (AHEI-2010) and Dietary Approach to Stop Hypertension (DASH) scores to compare diet quality between U.S.-born (n=3,837) and foreign-born (n=406) non-Hispanic Black adults aged 22-79y, based on pooled nationally representative data (NHANES 2003-2012); as well as by length of U.S. residency. Association between nativity and diet quality was done using multivariable-adjusted linear regression for the continuous total diet quality scores and their components, or multinomial (polytomous) logistic regression for categorical tertiles (low, medium, or high) of the total scores and their components. The study found that foreign-born Blacks had significantly higher AHEI-2010 and DASH scores compared to U.S-born Blacks, and more favorable intakes for many of the score components. Among foreign-born Blacks, diet quality did not significantly differ by length of residency. Foreign-born Blacks were more likely to be in the high than low tertile for fruit (including and excluding fruit juice), vegetables (excluding starchy vegetables), percent whole grains, and omega-3 fatty acids. Overall, the study suggests that foreign-born Blacks have better diet quality compared to their U.S.-born counterparts. Considering nativity among U.S. Blacks in nutrition research and public health efforts may therefore improve accuracy of characterizing dietary intakes and facilitate development of targeted nutrition interventions to reduce diet-related diseases in the diverse Black population in the U.S.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised 4,243 non-Hispanic Blacks, including 3,837 U.S.-born (90.4%) and 406 foreign-born (9.6%). Compared to U.S.-born Blacks, a higher proportion of foreign-born Blacks were male, had attained a higher level of education, were classified as normal or overweight, had never been a smoker, engaged in physical activity, and had lower energy intake. In comparison to those who were in the U.S. for <10 years, more foreign-born Blacks who were in the U.S. for ≥30 years were current smokers (14.8% vs. 5.0%, respectively), had higher income (IPR of ≥4.00: 43.5% vs 7.9%, respectively), and a higher percent with a college degree or higher (39.4% vs. 18.3%, respectively). Foreign-born Blacks residing in the U.S. for ≥30 years reported higher BMI in comparison to those residing in the U.S. for <10 years (28.8 vs. 26.7 kg/m2).
Key inclusion criteria (1 listed)
- 22-79
Key exclusion criteria (3 listed)
- Pregnant subjects
- Energy intakes of ≤600 kcal and ≥ 4800 kcal
- No dietary data available
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
Adapted AHEI-2010
Time frame: 2003-2012
Components include: fruit (excluding fruit juice) (s/d); vegetables (excluding white potatoes) (s/d); whole grains (oz-equivalents/d); sugar-sweetened beverages (s/d); nuts, legumes, and vegetable protein (oz-equivalents/d); red/processed meat (s/d); long-chain omega-3 fats (EPA+DHA; mg/d); polyunsaturated fats (PUFA; % kcal/d); sodium (mg/d); and alcohol (drinks/d). Potential range of 0-100 points and higher scores indicative of higher diet quality
1 secondary outcome
Adapted DASH score
Time frame: 2003-2012
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 30 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 Diet Habit, run by Sara C. Folta.
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 3 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 30 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?
Adapted AHEI-2010 (time frame: 2003-2012). 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 30 Aug 2017.