Child Obesity Clinical Trial
Official title:
Measuring the Effectiveness of Eatable Alphabet Cards as a Nutrition Education Tool in a Pediatric Weight Management Program
Verified date | September 2023 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cohen Children's Medical Center | New Hyde Park | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
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 |
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