NCT05166629

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2023Dec 2026

First Submitted

Initial submission to the registry

December 3, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

December 3, 2021

Last Update Submit

May 19, 2025

Conditions

Child OvernutritionChild ObesityChild Nutrition Disorders

Keywords

nutrition educationpediatric weight managementchild overweight/obesityfruit and vegetable consumption

Outcome Measures

Primary Outcomes (1)

  • Change in parent reported child vegetable consumption (servings/day)

    Parents will complete pre and post intervention/usual care survey measures of vegetable consumption.

    1 month

Secondary Outcomes (6)

  • Change in parent reported child fruit consumption (servings/day)

    1 month

  • Parent reported child engagement in meal selection/preparation

    1 month

  • Follow-up weight management visit attendance

    6 months

  • Change in child body mass index (BMI) z-score

    6 months

  • Change in weight for age (WFA) z-score

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Usual Care

OTHER

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.

Behavioral: Usual Care

Eatable Alphabet

EXPERIMENTAL

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.

Behavioral: Eatable Alphabet

Interventions

Eatable AlphabetBEHAVIORAL

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.

Eatable Alphabet
Usual CareBEHAVIORAL

Please see above description of usual care.

Usual Care

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \- No appropriate caregiver available for consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Related Links

MeSH Terms

Conditions

Child Nutrition DisordersPediatric ObesityObesity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle W Katzow, MD, MS

    Northwell Health and Feinstein Institutes for Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 22, 2021

Study Start

September 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)