Eatable Alphabet as a Nutrition Education Tool

Sponsor
Northwell Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05166629
Collaborator
(none)
240
2
30.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Eatable Alphabet
  • Behavioral: Usual Care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized control trialRandomized control trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Measuring the Effectiveness of Eatable Alphabet Cards as a Nutrition Education Tool in a Pediatric Weight Management Program
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Mar 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Usual Care

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
Please see above description of usual care.

Experimental: Eatable Alphabet

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in parent reported child vegetable consumption (servings/day) [1 month]

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

Secondary Outcome Measures

  1. Change in parent reported child fruit consumption (servings/day) [1 month]

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

  2. Parent reported child engagement in meal selection/preparation [1 month]

    Parents will complete pre and post intervention/usual care survey measures of child engagement in meal selection/preparation.

  3. Follow-up weight management visit attendance [6 months]

    We will determine whether the patient returned for scheduled follow-up visit via medical record review.

  4. Change in child body mass index (BMI) z-score [6 months]

    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.

  5. Change in weight for age (WFA) z-score [6 months]

    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. Change in percent of the 95th percentile of BMI for age and sex [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwell Health

Investigators

  • Principal Investigator: Michelle W Katzow, MD, MS, Northwell Health and Feinstein Institutes for Medical Research

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Michelle Katzow, Assistant Professor of Pediatrics, Northwell Health
ClinicalTrials.gov Identifier:
NCT05166629
Other Study ID Numbers:
  • 21-1152
First Posted:
Dec 22, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michelle Katzow, Assistant Professor of Pediatrics, Northwell Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022