SMART goals program for youth with prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a SMART goal-setting protocol in reducing body weight and improving metabolic parameters in obese children with prediabetes. Participants will be randomized to either receive the SMART Goal Setting Protocol or standard care, with both groups receiving consistent medical nutrition therapy. The study will assess changes in BMI Z-score, hemoglobin A1c, and lipid levels over a six-month period. By empowering children to set their own health goals, the study seeks to enhance motivation and engagement in managing their condition.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwell Health
  New York, New York, United States Recruiting
• Northwell Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Benjamin U. Nwosu, MD — Northwell Health, INC.
• Study coordinator: Thomas Zachmann, RD
• Email: tzachmann@northwell.edu
• Phone: (516) 472-3750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.