Eat Healthy for Families

NCT03394326 | Completed

• 1 other identifier: 1097650
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood; Energy Density; Diet Quality

Outcome Measures

Primary Outcomes (3)

• Dietary Energy Density

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

  6 months

• Energy Intake

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

  6 months

• Dietary Quality

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

  6 months

Secondary Outcomes (1)

• zBMI

  6 months

Study Arms (2)

LOW-ED

EXPERIMENTAL

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.

Behavioral: family-based obesity prevention lifestyle intervention

STANDARD

ACTIVE COMPARATOR

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.

Behavioral: family-based obesity prevention lifestyle intervention

Interventions

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.

LOW-ED; STANDARD

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: July 1, 2017
• Primary Completion: November 9, 2021
• Study Completion: December 31, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

US (1)