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Completed

NCT Number: NCT03394326

Eat Healthy for Families

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

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Key information

Conditions

Obesity, Childhood Body Weight Diet Quality Energy Density Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

family-based obesity prevention lifestyle intervention

Behavioral

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.

Primary outcomes

  1. Dietary Energy Density

    Time frame: 6 months

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

  2. Energy Intake

    Time frame: 6 months

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

  3. Dietary Quality

    Time frame: 6 months

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

Secondary outcomes

  1. zBMI

    Time frame: 6 months

    A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Implementing a Dietary Energy Density Intervention in Preschool Children

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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