Eat Healthy for Families

Not Applicable

Completed

• Conditions: Energy Density; Obesity, Childhood; Diet Quality
• Interventions: Behavioral: family-based obesity prevention lifestyle intervention

• Registration Number: NCT03394326
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Primary Completion: 2021-11-09
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOW-ED	family-based obesity prevention lifestyle intervention	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.
STANDARD	family-based obesity prevention lifestyle intervention	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.

Primary Outcome Measures

Name	Time	Method
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.
Dietary Energy Density	6 months	Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States