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Search / Trial NCT06067451

SMART GOALS for Youth With Prediabetes

Launched by NORTHWELL HEALTH · Sep 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Nutrition

ClinConnect Summary

The SMART GOALS for Youth With Prediabetes trial is studying how a specific goal-setting program can help obese children aged 10 to 18 with prediabetes improve their health. The program is designed to help them set clear, achievable health goals related to weight, diet, and physical activity. Researchers want to see if children using this program will have better health outcomes, such as lower body weight and improved blood sugar levels, after six months compared to those who do not use the program.

To participate, children need to be between 10 and 18 years old, have a higher-than-normal body weight for their age, and have a blood sugar level that suggests they are at risk for diabetes. Participants will receive support and tools to help them track their progress. It’s important to note that children with certain medical conditions or those on specific medications will not be eligible for this study. Overall, this trial aims to provide a structured way for young people to make healthier lifestyle changes and ultimately improve their health.

Gender

ALL

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 Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Benjamin U. Nwosu, MD

Principal Investigator

NORTHWELL HEALTH, INC.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported