Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05166629
Other study ID # 21-1152
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date March 30, 2026

Study information

Verified date September 2023
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 160
Est. completion date March 30, 2026
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years to 10 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Eatable Alphabet
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.
Usual Care
Please see above description of usual care.

Locations

Country Name City State
United States Cohen Children's Medical Center New Hyde Park New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in parent reported child fruit consumption (servings/day) Parents will complete pre and post intervention/usual care survey measures of fruit consumption. 1 month
Secondary 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. 1 month
Secondary Follow-up weight management visit attendance We will determine whether the patient returned for scheduled follow-up visit via medical record review. 6 months
Secondary 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. 6 months
Secondary 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. 6 months
Secondary 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. 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT06185413 - Children's Cooperation Denmark: a 3-year System Dynamics Trial N/A
Recruiting NCT05140070 - Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth N/A
Recruiting NCT06108128 - Food for Thought: Executive Functioning Around Eating Among Children N/A
Completed NCT04042467 - Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention N/A
Completed NCT01974102 - Family Based Mindfulness Intervention N/A
Recruiting NCT05403658 - Attrition in Pediatric Obesity Management N/A
Completed NCT04315220 - Corestability Training in Overweight Children N/A
Recruiting NCT05570396 - Long-term Follow-up on Childhood Adiposity - The FitKids Study
Recruiting NCT03643341 - Family Healthy Living Early Intervention Program N/A
Completed NCT03219658 - STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity N/A
Recruiting NCT05540678 - The FibreGum Study - Changing the Course of Obesity in Children N/A
Completed NCT04459130 - Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years N/A
Completed NCT05019339 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education N/A
Active, not recruiting NCT03950453 - Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention N/A
Completed NCT03982511 - Improving Parent-Child Interactions to Enhance Child Health N/A
Active, not recruiting NCT06317883 - Childhood Obesity Risk Assessment Longitudinal Study
Completed NCT02206529 - Enhancing Family Based Treatment of Childhood Obesity Through Social Networks N/A
Recruiting NCT06341179 - Effect of Sleep Extension on Overweight and Learning in Children N/A
Recruiting NCT04802291 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity N/A
Recruiting NCT05025852 - The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial

External Links