Eating BehaviorHEALTHNCT02725970
Healthy Eating and Lifestyle for Total Health
An observational study of Eating Behavior, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The Dietary Guidelines for Americans provide recommendations for making better food and physical activity choices that promote health and help prevent disease. Yet, few Americans meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight. Read more about this study
- Who is it for?
- Ages 8 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- survey
- How many people
- 836 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2015
- 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 8 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Fifth-grade children and their caregivers, or a caregiver of a 5th grade child attending a public school.
Who may be able to join
None listed.
Who cannot join
- Pregnant women were not recruited as their dietary intake was different because of pregnancy.
- Children not attending 5th grade in public school.
- Parents of children not attending 5th grade in public school
- parents of children attending 5th grade in public school but who were not responsible for the health of the child and who did not have the most influence in what the qualified child ate most days of the week.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA/ARS Children's Nutrition Research Center
Houston, Texas, 77030
About this study
The Dietary Guidelines for Americans provide recommendations for making better food and physical activity choices that promote health and help prevent disease. Yet, few Americans meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight.
Read the detailed description
The goal of the research was to examine the association between weight and the barriers and facilitators to meeting the DGA in a multi-site study using a cross-sectional survey. 836 caregiver-child dyads enrolled and completed the HEALTH study questionnaire across six sites among three race/ethnic groups participating in the HEALTH Study. Barriers and facilitators to meeting the DGA were assessed using a validated questionnaire which was developed specifically for the HEALTH Study. Heights and weights were measured. A series of bivariate regression analyses were conducted to examine the association between the caregivers BMI or the children BMI z-score and the barriers and facilitators to meeting the DGA, adjusting for appropriate covariates in the models. Path analysis was used to examine the relationship of caregivers and children barriers and facilitators to their relative BMI.
- Conditions
- Eating Behavior
- Being tested
- survey
- Keywords
- HEALTH, barriers, facilitators, DGA, BMI, Public Schools
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
Cross-sectional survey
| Study group | Role | What they receive |
|---|---|---|
| Children's Nutrition Research Center | Survey, no intervention. Receives: Other: survey | |
| Western Human Nutrition Research Center | Survey, no intervention. Receives: Other: survey | |
| Human Nutrition Research Center On Aging | Survey, no intervention. Receives: Other: survey | |
| Delta Obesity Prevention Research Center | Survey, no intervention. Receives: Other: survey | |
| Beltsville Human Nutr Research Center | Survey, no intervention. Receives: Other: survey | |
| Grand Forks Human Nutr Research Center | Survey, no intervention. Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring and Reporting on the Barriers and Facilitators to Meeting the Dietary Guidelines of Americans among 5th Graders and the Caregivers of 5th Graders Was Assessed Using Questionnaires.
Measured: 3/2010- 7/2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Dairy Management Inc.
- Responsible party
- Principal investigator, Theresa A Nicklas, Baylor College of Medicine
- Investigators
- Theresa A Nicklas, DrPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725970
- Sponsor's protocol ID
- H-23839
- Acronym
- HEALTH
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nicklas TA, Jahns L, Bogle ML, Chester DN, Giovanni M, Klurfeld DM, Laugero K, Liu Y, Lopez S, Tucker KL. Barriers and facilitators for consumer adherence to the dietary guidelines for Americans: the HEALTH study. J Acad Nutr Diet. 2013 Oct;113(10):1317-31. doi: 10.1016/j.jand.2013.05.004. Epub 2013 Jul 17.
PubMed 23871110Nicklas T, Liu Y, Giovanni M, Jahns L, Tucker K, Laugero K, Bogle M, Chester D. Association between barriers and facilitators to meeting the Dietary Guidelines for Americans and body weight status of caregiver-child dyads: the Healthy Eating and Lifestyle for Total Health Study. Am J Clin Nutr. 2016 Jul;104(1):143-54. doi: 10.3945/ajcn.115.123372. Epub 2016 May 18.
PubMed 27194306
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating and Lifestyle for Total Health
- ClinicalTrials.gov ID
- NCT02725970
- Acronym / sponsor ID
- HEALTH / H-23839
- Conditions
- Eating Behavior
- Keywords
- HEALTH, barriers, facilitators, DGA, BMI, Public Schools
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 836 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Dairy Management Inc.
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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 Dietary Guidelines for Americans provide recommendations for making better food and physical activity choices that promote health and help prevent disease. Yet, few Americans meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight.
Detailed description
The goal of the research was to examine the association between weight and the barriers and facilitators to meeting the DGA in a multi-site study using a cross-sectional survey. 836 caregiver-child dyads enrolled and completed the HEALTH study questionnaire across six sites among three race/ethnic groups participating in the HEALTH Study. Barriers and facilitators to meeting the DGA were assessed using a validated questionnaire which was developed specifically for the HEALTH Study. Heights and weights were measured. A series of bivariate regression analyses were conducted to examine the association between the caregivers BMI or the children BMI z-score and the barriers and facilitators to meeting the DGA, adjusting for appropriate covariates in the models. Path analysis was used to examine the relationship of caregivers and children barriers and facilitators to their relative BMI.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Children's Nutrition Research Center | – | Other: surveySurvey, no intervention. |
| Western Human Nutrition Research Center | – | Other: surveySurvey, no intervention. |
| Human Nutrition Research Center On Aging | – | Other: surveySurvey, no intervention. |
| Delta Obesity Prevention Research Center | – | Other: surveySurvey, no intervention. |
| Beltsville Human Nutr Research Center | – | Other: surveySurvey, no intervention. |
| Grand Forks Human Nutr Research Center | – | Other: surveySurvey, no intervention. |
Who may qualify
- Ages
- 8 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Fifth-grade children and their caregivers, or a caregiver of a 5th grade child attending a public school.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Pregnant women were not recruited as their dietary intake was different because of pregnancy.
- Children not attending 5th grade in public school.
- Parents of children not attending 5th grade in public school
- parents of children attending 5th grade in public school but who were not responsible for the health of the child and who did not have the most influence in what the qualified child ate most days of the week.
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 |
|---|---|---|
| surveyCross-sectional survey | Other | Beltsville Human Nutr Research Center, Children's Nutrition Research Center, Delta Obesity Prevention Research Center, Grand Forks Human Nutr Research Center, Human Nutrition Research Center On Aging, Western Human Nutrition Research Center |
Primary outcome
Measuring and Reporting on the Barriers and Facilitators to Meeting the Dietary Guidelines of Americans among 5th Graders and the Caregivers of 5th Graders Was Assessed Using Questionnaires.
Time frame: 3/2010- 7/2012
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 1 Apr 2016.
- Background: PubMed 23871110Nicklas TA, Jahns L, Bogle ML, Chester DN, Giovanni M, Klurfeld DM, Laugero K, Liu Y, Lopez S, Tucker KL. Barriers and facilitators for consumer adherence to the dietary guidelines for Americans: the HEALTH study. J Acad Nutr Diet. 2013 Oct;113(10):1317-31. doi: 10.1016/j.jand.2013.05.004. Epub 2013 Jul 17.
- Derived from this study: PubMed 27194306Nicklas T, Liu Y, Giovanni M, Jahns L, Tucker K, Laugero K, Bogle M, Chester D. Association between barriers and facilitators to meeting the Dietary Guidelines for Americans and body weight status of caregiver-child dyads: the Healthy Eating and Lifestyle for Total Health Study. Am J Clin Nutr. 2016 Jul;104(1):143-54. doi: 10.3945/ajcn.115.123372. Epub 2016 May 18.
- 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.
Theresa A Nicklas, DrPH principal investigator
Baylor College of Medicine
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 Eating Behavior, run by Baylor College of 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 0 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: finished, as of the sponsor's last update on 1 Apr 2016. 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?
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?
Measuring and Reporting on the Barriers and Facilitators to Meeting the Dietary Guidelines of Americans among 5th Graders and the Caregivers of 5th Graders Was Assessed Using Questionnaires. (time frame: 3/2010- 7/2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725970, which also lists 2 linked publications.
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 1 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.