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SMART GOALS for Youth With Prediabetes

Recruiting

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

Sponsor: Northwell Health · Participants: 80 · Started: Dec 10, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06067451

Locations in the U.S.

New YorkNorthwell 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.