SMART goals program 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.
This study is testing if a special goal-setting program can help overweight kids with prediabetes lose weight and improve their health compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06067451 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 10-18 years with a BMI at or above the 85th percentile and hemoglobin A1c levels between 5.7% and 6.4%.
Not a fit: Patients who are not interested in weight loss or lifestyle changes, or those with existing diabetes or certain psychiatric disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant improvements in weight management and metabolic health for children at risk of type 2 diabetes.
How similar studies have performed: Previous studies have shown promise in using goal-setting strategies for behavior change in pediatric populations, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.