Status:
UNKNOWN
SMART GOALS for Youth With Prediabetes
Lead Sponsor:
Northwell Health
Conditions:
PreDiabetes
Adolescent Obesity
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
The goal of this study is to compare the impact of a SMART ((specific, measurable, attainable, realistic, or timely) Goal setting protocol on body weight, metabolic parameters (Hemoglobin A1c, lipids)...
Detailed Description
Implementing a SMART goal-setting protocol for the overweight and obese pediatric population with prediabetes can benefit patients by empowering participants to set their own goals. In addition, utili...
Eligibility Criteria
Inclusion
- Children between ages 10-18 years at baseline visit
- Children with BMI for age and sex ≥ 85th percentile at baseline visit
- Children with hemoglobin A1c 5.7% to 6.4% at baseline visit
Exclusion
- Children who are not able to provide assent to the study
- Children less than 10 years in age
- Children that are not interested in weight loss or diet and lifestyle change
- Children with known diabetes that use medications that alter glucose or lipid metabolism such as (insulin, metformin, Glucagon Like Peptide-1 Receptor Antagonist (GLP-1 RA), Statins, Accutane).
- Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
- Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)
- Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis
- Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness
- Children with known or suspected eating disorders as identified through the electronic medical record
- Children that have known genetic or syndromic obesity
- Female children who are pregnant
Key Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06067451
Start Date
December 10 2023
End Date
December 10 2025
Last Update
December 14 2023
Active Locations (2)
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1
Northwell Health
New York, New York, United States, 11042
2
Northwell Health
New York, New York, United States, 11042