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SMART GOAL Arm for 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Temporal changes in Hemoglobin A1c between the study and control groups

Temporal changes in Lipids

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

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,963 Total Patients Enrolled

Benjamin U. Nwosu, MDPrincipal InvestigatorNORTHWELL HEALTH, INC.

1 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation accepted in this experiment?

"As per the stated parameters, potential participants must be 10 or older but no older than 18."

Answered by AI

Am I eligible to partake in this research program?

"Candidates between the ages of 10 and 18 that have healthy behaviors may be considered for this clinical trial, which is recruiting approximately 80 individuals."

Answered by AI

Are enrollments still open to join this research effort?

"The data on clinicaltrials.gov denotes that this medical trial is actively enrolling patients; it was first posted in December 10th 2023 and most recently updated three days later."

Answered by AI

How many participants are involved with this research project?

"Correct. The details hosted on clinicaltrials.gov declare that this medical research, which was originally posted on December 10th 2023, is currently looking for participants. Around 80 individuals must be enrolled from a single centre."

Answered by AI

Recent research and studies

JamaJournal

Differences in Obesity Prevalence by Demographic Characteristics and Urbanization Level Among Adults in the United States, 2013-2016

Hales, Craig M., Cheryl D. Fryar, Margaret D. Carroll, David S. Freedman, Yutaka Aoki, and Cynthia L. Ogden. 2018. “Differences in Obesity Prevalence by Demographic Characteristics and Urbanization Level Among Adults in the United States, 2013-2016”. Jama. American Medical Association (AMA). doi:10.1001/jama.2018.7270.

clinicaltrials.govStudy

SMART GOALS for Youth With Prediabetes

2023. "SMART GOALS for Youth With Prediabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067451.

All > Prediabetes