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Eat Healthy for Families

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University of Delaware

Status

Completed

Conditions

Obesity, Childhood
Diet Quality
Energy Density

Treatments

Behavioral: family-based obesity prevention lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03394326
1097650

Details and patient eligibility

About

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

Enrollment

41 patients

Sex

All

Ages

2 to 5 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 2 patient groups

LOW-ED
Experimental group
Description:
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.
Treatment:
Behavioral: family-based obesity prevention lifestyle intervention
STANDARD
Active Comparator group
Description:
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.
Treatment:
Behavioral: family-based obesity prevention lifestyle intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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