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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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:

0 / 2Eligibility criteria met