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SMART GOALS for Youth With Prediabetes
Impact of SMART GOAL Setting Protocol on Body Weight and Metabolic Parameters in Children and Adolescents With Prediabetes; a Randomized Clinical Trial.
Who can join
Ages 10 to 18 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Children between ages 10-18 years at baseline visit 2. Children with BMI for age and sex ≥ 85th percentile at baseline visit 3. Children with hemoglobin A1c 5.7% to 6.4% at baseline visit Exclusion Criteria: 1. Children who are not able to provide assent to the study 2. Children less than 10 years in age 3. Children that are not interested in weight loss or diet and lifestyle change 4. 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). 5. Children on medications that can alter body weight (including antidepressants, steroids, stimulants). 6. Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder) 7. Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis 8. Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness 9. Children with known or suspected eating disorders as identified through the electronic medical record 10. Children that have known genetic or syndromic obesity 11. Female children who are pregnant
About the study
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), diet quality and physical activity frequency in obese children with prediabetes in the outpatient setting. The main question is if participants using the SMART Goal Setting Protocol (SGSP) will have a significant reduction. The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), in BMI Z-score, A1c, and dyslipidemia in 6 months compared to controls.
What is being tested
- SMART GOALS Setting Tool/ Protocol (behavioral)
Sponsor: Northwell Health · Participants: 80 · Started: Dec 10, 2023
Contact the study team
- Thomas Zachmann, RD · Phone: (516) 472-3750
- Rashida Talib, MPH · Phone: (516)472-3631
Official record on ClinicalTrials.gov — NCT06067451
Locations in the U.S.
| New York | Northwell Health, New York Northwell Health, New York |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.