Eat Healthy for Families

Obesity, Childhood Clinical Trial

Official title:

Implementing a Dietary Energy Density Intervention in Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394326
• Other study ID #: 1097650
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Quality
• Energy Density
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary Energy Density	Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.	6 months
Primary	Energy Intake	Dietary intake will be analyzed using NDSR and energy intake will be calculated.	6 months
Primary	Dietary Quality	Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.	6 months
Secondary	zBMI	A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.	6 months