Eat Healthy for Families

May 16, 2022 updated by: Shannon Robson, University of Delaware

Implementing a Dietary Energy Density Intervention in Preschool Children

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19716
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LOW-ED
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
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.
Active Comparator: STANDARD
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Energy Density
Time Frame: 6 months
Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.
6 months
Energy Intake
Time Frame: 6 months
Dietary intake will be analyzed using NDSR and energy intake will be calculated.
6 months
Dietary Quality
Time Frame: 6 months
Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
zBMI
Time Frame: 6 months
A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

November 9, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1097650

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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