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SMART Goals for Childhood Prediabetes
N/A
Recruiting
Led By Benjamin U. Nwosu, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children between ages 10-18 years at baseline visit
Children with BMI for age and sex ≥ 85th percentile at baseline visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a SMART Goal setting protocol can help obese children with prediabetes reduce their BMI & A1c levels & improve diet & exercise.
Who is the study for?
This trial is for obese children aged 10-18 with prediabetes, indicated by a BMI ≥ 85th percentile and Hemoglobin A1c levels between 5.7% to 6.4%. It's designed to help them improve their health habits.
What is being tested?
The study tests if the SMART Goals protocol can help these kids lose weight and improve metabolic health within six months compared to those who don't use this method.
What are the potential side effects?
Since the intervention involves lifestyle changes rather than medication, side effects are minimal but may include stress or frustration related to meeting set goals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 18 years old.
Select...
My child's BMI is in the top 15% for their age and sex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the impact of SMART Goal setting on BMI z-scores To determine the impact of SMART Goal setting on BMI z-scores
Secondary study objectives
Temporal changes in Hemoglobin A1c between the study and control groups
Temporal changes in Lipids
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SMART GOAL ArmExperimental Treatment1 Intervention
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), which will be used in tandem.
The study group participants will also be asked to summarize the information discussed during the visit, and then will receive the SMART (Specific, Measurable, Attainable, Realistic, Time sensitive) Goal Setting Protocol (SGSP).
Group II: Standard of Care ArmActive Control1 Intervention
Participants randomized to this group will receive standard of care.
At the end of each visit, the participants in the standard of care (SOC) group will be asked to provide a summary of topics discussed and what they plan to improve on from now and their next visit:
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
475 Previous Clinical Trials
469,204 Total Patients Enrolled
Benjamin U. Nwosu, MDPrincipal InvestigatorNORTHWELL HEALTH, INC.
1 Previous Clinical Trials
50 Total Patients Enrolled