Last updated: December 13, 2023
Sponsor: Northwell Health
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Mellitus Types I And Ii
Diabetes And Hypertension
Diabetes Prevention
Treatment
SMART GOALS Setting Tool/ Protocol
Clinical Study ID
NCT06067451
23-0375
Ages 10-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 lipidmetabolism 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 identifiedthrough the electronic medical record (such as cognitive disability or autism spectrumdisorder)
- Children with known psychiatric disorders disabilities as identified through theelectronic medical record (e.g., schizophrenia, depression, bipolar disorder, orpsychosis
- 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 electronicmedical record
- Children that have known genetic or syndromic obesity
- Female children who are pregnant
Study Design
Total Participants: 80
Treatment Group(s): 1
Primary Treatment: SMART GOALS Setting Tool/ Protocol
Phase:
Study Start date:
December 10, 2023
Estimated Completion Date:
December 10, 2025
Study Description
Connect with a study center
Northwell Health
New York, New York 11042
United StatesActive - Recruiting
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