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Healthy Eating and Lifestyle for Total Health (HEALTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02725970
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : April 1, 2016
Sponsor:
Collaborators:
United States Department of Agriculture (USDA)
Dairy Management Inc.
Information provided by (Responsible Party):
Theresa A Nicklas, Baylor College of Medicine

Tracking Information
First Submitted Date March 22, 2016
First Posted Date April 1, 2016
Last Update Posted Date April 1, 2016
Study Start Date January 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 31, 2016)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Healthy Eating and Lifestyle for Total Health
Official Title Healthy Eating and Lifestyle for Total Health
Brief 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.
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
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Eating Behavior
Intervention Other: survey
Cross-sectional survey
Study Groups/Cohorts
  • Children's Nutrition Research Center
    Survey, no intervention.
    Intervention: Other: survey
  • Western Human Nutrition Research Center
    Survey, no intervention.
    Intervention: Other: survey
  • Human Nutrition Research Center On Aging
    Survey, no intervention.
    Intervention: Other: survey
  • Delta Obesity Prevention Research Center
    Survey, no intervention.
    Intervention: Other: survey
  • Beltsville Human Nutr Research Center
    Survey, no intervention.
    Intervention: Other: survey
  • Grand Forks Human Nutr Research Center
    Survey, no intervention.
    Intervention: Other: survey
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 31, 2016)
836
Original Actual Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria
  1. 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)
  2. Attend public school and caregiver to a child in a public school
  3. Fell in one of three racial/ethnic groups (African Americans, Hispanics, White)

Exclusion Criteria:

  1. Pregnant women were not recruited as their dietary intake was different because of pregnancy.
  2. Children not attending 5th grade in public school.
  3. Parents of children not attending 5th grade in public school
  4. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 64 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02725970
Other Study ID Numbers H-23839
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Theresa A Nicklas, Baylor College of Medicine
Study Sponsor Baylor College of Medicine
Collaborators
  • United States Department of Agriculture (USDA)
  • Dairy Management Inc.
Investigators
Principal Investigator: Theresa A Nicklas, DrPH Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date March 2016