NCT06067451Recruiting
SMART GOALS 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.
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 15 Sept 2023
- Start date
- 10 Dec 2023
- Primary completion date
- 27 Feb 2027
- Lead sponsor
- Northwell Health
- Diseases
- Obesity
- NCT number
- NCT06067451
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 10 Dec 2023 to the primary completion date, 27 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
Other illness
- Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)
- Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis
- Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness
- Children with known or suspected eating disorders as identified through the electronic medical record
Lab values
- 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).
Age
- Children less than 10 years in age
Other
- Children who are not able to provide assent to the study
- Children that are not interested in weight loss or diet and lifestyle change
- Children that have known genetic or syndromic obesity
- Female children who are pregnant
Who the study is looking for
- Children between ages 10-18 years at baseline visit
- Children with BMI for age and sex ≥ 85th percentile at baseline visit
- Children with hemoglobin A1c 5.7% to 6.4% at baseline visit
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwell Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.