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Clinical Trials/NCT03394326
NCT03394326CompletedNot Applicable

Implementing a Dietary Energy Density Intervention in Preschool Children

University of Delaware1 site in 1 country41 target enrollmentStarted: July 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
Energy Intake

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
2 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

LOW-ED

Experimental

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.

Intervention: family-based obesity prevention lifestyle intervention (Behavioral)

STANDARD

Active Comparator

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.

Intervention: family-based obesity prevention lifestyle intervention (Behavioral)

Outcomes

Primary Outcomes

Energy Intake

Time Frame: 6 months

Dietary intake will be analyzed using NDSR and energy intake will be calculated.

Dietary Quality

Time Frame: 6 months

Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.

Dietary Energy Density

Time Frame: 6 months

Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.

Secondary Outcomes

  • zBMI(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shannon Robson

Principal Investigator

University of Delaware

Study Sites (1)

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