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SMART GOALS for Youth With Prediabetes

Sponsor: Northwell Health • ClinicalTrials.gov ID: NCT06067451

Registry updated: 2026-10-20

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Description

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.

Interventions

SMART GOALS Setting Tool/ Protocol (Behavioral)
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), which will be used in tandem. The participant will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for.

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

Conditions

PreDiabetes Adolescent Obesity Behavior, Health Nutritional and Metabolic Diseases Diet Habit Lifestyle Risk Reduction

Locations

Northwell Health — New York, New York, United States
Northwell Health — New York, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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