Eat Healthy for Families

Implementing a Dietary Energy Density Intervention in Preschool Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03394326

Enrollment

Registered

2018-01-09

Start date

2017-07-01

Completion date

2021-12-31

Last updated

2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Quality, Energy Density, Obesity, Childhood

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.

Interventions

BEHAVIORALfamily-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Dietary Energy Density	6 months	Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.
Energy Intake	6 months	Dietary intake will be analyzed using NDSR and energy intake will be calculated.
Dietary Quality	6 months	Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.

Secondary

Measure	Time frame	Description
zBMI	6 months	A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026