- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02725970
Healthy Eating and Lifestyle for Total Health (HEALTH)
March 31, 2016 updated by: Theresa A Nicklas, Baylor College of Medicine
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
836
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
-
Houston, Texas, United States, 77030
- USDA/ARS Children's Nutrition Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 64 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Fifth-grade children and their caregivers, or a caregiver of a 5th grade child attending a public school.
Description
- Children in grade 5 and primary caregiver of a child in the 5th grade (the primary caregiver was defined as the person responsible for the health of the child and who has the most influence in what the child eats most days of the week)
- Attend public school and caregiver to a child in a public school
- Fell in one of three racial/ethnic groups (African Americans, Hispanics, White)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children's Nutrition Research Center
Survey, no intervention.
|
Cross-sectional survey
|
Western Human Nutrition Research Center
Survey, no intervention.
|
Cross-sectional survey
|
Human Nutrition Research Center On Aging
Survey, no intervention.
|
Cross-sectional survey
|
Delta Obesity Prevention Research Center
Survey, no intervention.
|
Cross-sectional survey
|
Beltsville Human Nutr Research Center
Survey, no intervention.
|
Cross-sectional survey
|
Grand Forks Human Nutr Research Center
Survey, no intervention.
|
Cross-sectional survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3/2010- 7/2012
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Nicklas 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
August 1, 2012
Study Completion (ACTUAL)
June 1, 2015
Study Registration Dates
First Submitted
March 22, 2016
First Submitted That Met QC Criteria
March 31, 2016
First Posted (ESTIMATE)
April 1, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
April 1, 2016
Last Update Submitted That Met QC Criteria
March 31, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-23839
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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