Back to resultsEat Healthy for Families
Primary Purpose
Obesity, Childhood, Energy Density, Diet Quality
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
family-based obesity prevention lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
Eligibility Criteria
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.
Sites / Locations
- University of Delaware
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LOW-ED
STANDARD
Arm 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.
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.
Outcomes
Primary Outcome Measures
Dietary Energy Density
Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.
Energy Intake
Dietary intake will be analyzed using NDSR and energy intake will be calculated.
Dietary Quality
Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.
Secondary Outcome Measures
zBMI
A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03394326
Brief Title
Eat Healthy for Families
Official Title
Implementing a Dietary Energy Density Intervention in Preschool Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Energy Density, Diet Quality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LOW-ED
Arm Type
Experimental
Arm 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.
Arm Title
STANDARD
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
family-based obesity prevention lifestyle intervention
Intervention Description
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 Outcome Measure Information:
Title
Dietary Energy Density
Description
Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.
Time Frame
6 months
Title
Energy Intake
Description
Dietary intake will be analyzed using NDSR and energy intake will be calculated.
Time Frame
6 months
Title
Dietary Quality
Description
Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
zBMI
Description
A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Eat Healthy for Families
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