SMART GOALS for Youth With Prediabetes
Status unconfirmed · Not applicable
Conditions studied: PreDiabetes, Adolescent Obesity, Behavior, Health, Nutritional and Metabolic Diseases, Diet Habit, Lifestyle Risk Reduction
In brief
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.
Key facts
- Study ID
- NCT06067451
- Run by
- Northwell Health
- People needed
- 80
- Starts
- 2023-12-10
- Expected to finish
- 2025-12-10
- Last updated by the study team
- 2023-12-14
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 may not qualify 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 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
Where it is running
- Northwell Health — New York, New York, United States (enrolling)
- Northwell Health — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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