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Eatable Alphabet as a Nutrition Education Tool

Primary Purpose

Child Overnutrition, Child Obesity, Child Nutrition Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eatable Alphabet
Usual Care
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Overnutrition focused on measuring nutrition education, pediatric weight management, child overweight/obesity, fruit and vegetable consumption

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New patient at Cohen Children's Medical Center POWER Kids weight management program (defined as not having been seen by the program within the past 2 years)
  • Child between the ages of 2-10
  • English-speaking

Exclusion Criteria:

- No appropriate caregiver available for consent.

Sites / Locations

  • Cohen Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual Care

Eatable Alphabet

Arm Description

Usual care in the POWER Kids weight management program includes a nutrition assessment and education by a registered dietician nutritionist (RD). This includes taking a detailed dietary history, and providing individualized counseling, motivational interviewing, and nutrition education handouts/ web-based resources.

The intervention group will receive usual care, as described above, plus a set of Eatable Alphabet cards, which will be utilized during the visit for counseling and education, and given to the family to take home and use as they wish.

Outcomes

Primary Outcome Measures

Change in parent reported child vegetable consumption (servings/day)
Parents will complete pre and post intervention/usual care survey measures of vegetable consumption.

Secondary Outcome Measures

Change in parent reported child fruit consumption (servings/day)
Parents will complete pre and post intervention/usual care survey measures of fruit consumption.
Parent reported child engagement in meal selection/preparation
Parents will complete pre and post intervention/usual care survey measures of child engagement in meal selection/preparation.
Follow-up weight management visit attendance
We will determine whether the patient returned for scheduled follow-up visit via medical record review.
Change in child body mass index (BMI) z-score
Weight and height measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to calculate body mass index (BMI=kg/m^2). Software will use Centers for Disease Control and Prevention (CDC) reference standards to convert BMI into a BMI z-score based on the child's age and sex. Change in BMI z-score will be defined as BMI z-score 6 months (+/- 3 months) after the intervention visit minus BMI z-score at the baseline intervention visit.
Change in weight for age (WFA) z-score
Weight measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to generate weight for age (WFA) z-scores using CDC reference standards. Change in WFA z-score will be defined as WFA z-score 6 months (+/- 3 months) after the intervention visit minus WFA z-score at the baseline intervention visit.
Change in percent of the 95th percentile of BMI for age and sex
Weight and height measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to calculate body mass index (BMI=kg/m^2). Software will use CDC reference standards to convert BMI into a percent of the 95th percentile for the child's age and sex. Change in percent of the 95th percentile will be defined as percent of the 95th percentile 6 months (+/- 3 months) after the intervention visit minus percent of the 95th percentile z-score at the baseline intervention visit.

Full Information

First Posted
December 3, 2021
Last Updated
September 18, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT05166629
Brief Title
Eatable Alphabet as a Nutrition Education Tool
Official Title
Measuring the Effectiveness of Eatable Alphabet Cards as a Nutrition Education Tool in a Pediatric Weight Management Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

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 pilot randomized controlled trial will test the effectiveness of Eatable Alphabet cards, a child friendly nutrition education tool, on child weight and related behaviors in a clinical sample of 2 to 10-year-old children with overweight/obesity, referred to a pediatric weight management program.
Detailed Description
The goal of this research study is to determine whether the use of Eatable Alphabet cards in addition to standard weight management in a primary care setting will increase vegetable consumption. Additional outcomes that will be examined include fruit consumption, child engagement in meal selection and preparation, and clinic follow-up. If the intervention shows a significant effect in the above outcome measures, Eatable Alphabet cards can be implemented as a standard component of obesity management in primary care settings. It is hypothesized that the intervention will increase vegetable consumption, increase child engagement in meal selection and preparation, and increase clinic follow-up. The study design is randomized control trial, in which the control group includes parent-child dyads receiving care as usual in the weight management program, including nutrition education, and the intervention group includes parent-child dyads receiving care as usual in the weight management program plus Eatable Alphabet cards in addition to typical nutrition education. All study participants will be families receiving care at the POWER Kids Weight Management Program at 410 Lakeville Road, with the child between the ages of 2 and 10 who have overweight or obesity. The primary outcome is parent reported frequency of child vegetable consumption. Secondary outcomes include: parent reported frequency of child fruit consumption, parent reported child engagement in meal selection/preparation, follow-up weight management visit attendance, and child anthropometric outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Overnutrition, Child Obesity, Child Nutrition Disorders
Keywords
nutrition education, pediatric weight management, child overweight/obesity, fruit and vegetable consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual care in the POWER Kids weight management program includes a nutrition assessment and education by a registered dietician nutritionist (RD). This includes taking a detailed dietary history, and providing individualized counseling, motivational interviewing, and nutrition education handouts/ web-based resources.
Arm Title
Eatable Alphabet
Arm Type
Experimental
Arm Description
The intervention group will receive usual care, as described above, plus a set of Eatable Alphabet cards, which will be utilized during the visit for counseling and education, and given to the family to take home and use as they wish.
Intervention Type
Behavioral
Intervention Name(s)
Eatable Alphabet
Intervention Description
Eatable Alphabet is a set of kitchen activity cards developed by ChopChop Family, in collaboration with the American Academy of Pediatrics, with funding from the CDC (https://www.chopchopfamily.org/eatable-alphabet/). It includes a series of alphabet cards with family-friendly recipes.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Please see above description of usual care.
Primary Outcome Measure Information:
Title
Change in parent reported child vegetable consumption (servings/day)
Description
Parents will complete pre and post intervention/usual care survey measures of vegetable consumption.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in parent reported child fruit consumption (servings/day)
Description
Parents will complete pre and post intervention/usual care survey measures of fruit consumption.
Time Frame
1 month
Title
Parent reported child engagement in meal selection/preparation
Description
Parents will complete pre and post intervention/usual care survey measures of child engagement in meal selection/preparation.
Time Frame
1 month
Title
Follow-up weight management visit attendance
Description
We will determine whether the patient returned for scheduled follow-up visit via medical record review.
Time Frame
6 months
Title
Change in child body mass index (BMI) z-score
Description
Weight and height measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to calculate body mass index (BMI=kg/m^2). Software will use Centers for Disease Control and Prevention (CDC) reference standards to convert BMI into a BMI z-score based on the child's age and sex. Change in BMI z-score will be defined as BMI z-score 6 months (+/- 3 months) after the intervention visit minus BMI z-score at the baseline intervention visit.
Time Frame
6 months
Title
Change in weight for age (WFA) z-score
Description
Weight measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to generate weight for age (WFA) z-scores using CDC reference standards. Change in WFA z-score will be defined as WFA z-score 6 months (+/- 3 months) after the intervention visit minus WFA z-score at the baseline intervention visit.
Time Frame
6 months
Title
Change in percent of the 95th percentile of BMI for age and sex
Description
Weight and height measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to calculate body mass index (BMI=kg/m^2). Software will use CDC reference standards to convert BMI into a percent of the 95th percentile for the child's age and sex. Change in percent of the 95th percentile will be defined as percent of the 95th percentile 6 months (+/- 3 months) after the intervention visit minus percent of the 95th percentile z-score at the baseline intervention visit.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New patient at Cohen Children's Medical Center POWER Kids weight management program (defined as not having been seen by the program within the past 2 years) Child between the ages of 2-10 English-speaking Exclusion Criteria: - No appropriate caregiver available for consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle W Katzow, MD, MS
Organizational Affiliation
Northwell Health and Feinstein Institutes for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cohen Children's Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.chopchopfamily.org/eatable-alphabet/
Description
Related Info

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Eatable Alphabet as a Nutrition Education Tool

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