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Eat Healthy for Families

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ClinicalTrials.gov Identifier: NCT03394326
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Shannon Robson, University of Delaware

Brief Summary:
This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Energy Density Diet Quality Behavioral: family-based obesity prevention lifestyle intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementing a Dietary Energy Density Intervention in Preschool Children
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: LOW-ED
In the LOW-ED condition each participant will consume at least 10 low-ED foods/day (ED ≤1.0 kcal/g) and no more than 2 high ED foods/day (ED ≥3.0 kcal/g). Foods with an ED >1.0 kcal/g and <3.0 kcal/g will be unlimited; however, lowering the overall ED of the diet will be encouraged.
Behavioral: family-based obesity prevention lifestyle intervention
A family-based obesity prevention lifestyle intervention is based on the combination of behavioral therapy strategies, a physical activity prescription and a dietary prescription. Both the parent and child will be working to achieve the same behavioral targets.

Active Comparator: STANDARD
In the STANDARD condition participants will consume the recommendations for calories, fruits, vegetables and whole grains based on age and sex corresponding with MyPlate. The daily caloric recommendations from MyPlate are for weight maintenance.
Behavioral: family-based obesity prevention lifestyle intervention
A family-based obesity prevention lifestyle intervention is based on the combination of behavioral therapy strategies, a physical activity prescription and a dietary prescription. Both the parent and child will be working to achieve the same behavioral targets.




Primary Outcome Measures :
  1. Dietary Energy Density [ Time Frame: 6 months ]
    Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.

  2. Energy Intake [ Time Frame: 6 months ]
    Dietary intake will be analyzed using NDSR and energy intake will be calculated.

  3. Dietary Quality [ Time Frame: 6 months ]
    Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.


Secondary Outcome Measures :
  1. zBMI [ Time Frame: 6 months ]
    A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity);
  • the child is 2-5 years-old with a BMI-for-age and sex <95th percentile;
  • the parent and child live together ≥50% of the time;
  • the parent and child are able to read, speak and understand English;
  • the family has transportation to the University of Delaware; and
  • the family is committed to the 6-month program.

Exclusion Criteria:

  • the child is participating in a weight management program or seeing a Registered Dietitian for weight loss;
  • the child is taking weight loss medication or medication that impacts appetite; or
  • the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394326


Contacts
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Contact: Shannon M Robson, PhD, MPH, RD 302-831-6674 robson@udel.edu

Locations
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United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19716
Contact: Shannon Robson, PhD, MPH, RD    302-831-2241    robson@udel.edu   
Sponsors and Collaborators
University of Delaware
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Responsible Party: Shannon Robson, Principal Investigator, University of Delaware
ClinicalTrials.gov Identifier: NCT03394326    
Other Study ID Numbers: 1097650
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms