Clinical trial NCT05166629: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Child Overnutrition
Child Obesity
Child Nutrition Disorders
Keywords: nutrition education
pediatric weight management
child overweight/obesity
fruit and vegetable consumption
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in parent reported child vegetable consumption (servings/day)
timeFrame: 1 month
Secondary outcomes:
measure: Change in parent reported child fruit consumption (servings/day)
timeFrame: 1 month
measure: Parent reported child engagement in meal selection/preparation
timeFrame: 1 month
measure: Follow-up weight management visit attendance
timeFrame: 6 months
measure: Change in child body mass index (BMI) z-score
timeFrame: 6 months
measure: Change in weight for age (WFA) z-score
timeFrame: 6 months
measure: Change in percent of the 95th percentile of BMI for age and sex
timeFrame: 6 months
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
Study officials:
affiliation: Northwell Health and Feinstein Institutes for Medical Research
name: Michelle W Katzow, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: