Clinical trial for PreDiabetes
Official title SMART GOALS for Youth With Prediabetes
ClinicalTrials.gov ID: NCT06067451
What this study is testing
- What it's testing
- The study wants to see if using a SMART goal‑setting protocol can lower body weight, blood sugar (A1c), and cholesterol in obese teens with prediabetes.
- Who it's for
- It is looking for adolescents who are obese and have prediabetes.
- What's involved
- Participants in the intervention group will use a SMART Goal Selection Guide and a Weekly Goal Monitoring Tool to set and track goals for weight, blood sugar, and diet. They will have regular check‑ins and measurements of weight, A1c, and lipids.
- Time commitment
- The study lasts 6 months, with visits and measurements at the start and at the end of the study period.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- 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
You likely can't join if
- Children who are not able to provide assent to the study
- Children less than 10 years in age
- Children that are not interested in weight loss or diet and lifestyle change
- Children with known diabetes that use medications that alter glucose or lipid metabolism such as (insulin, metformin, Glucagon Like Peptide-1...
- Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
- Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability...
See the full eligibility criteria
- 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
- Children who are not able to provide assent to the study
- Children less than 10 years in age
- Children that are not interested in weight loss or diet and lifestyle change
- 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).
- Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
- 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
- Children that have known genetic or syndromic obesity
- Female children who are pregnant
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.