SMART GOALS for Youth With Prediabetes

Description

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.

Conditions

PreDiabetes, Adolescent Obesity, Behavior, Health, Nutritional and Metabolic Diseases, Diet Habit, Lifestyle Risk Reduction

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Study Overview

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Study Details

Study overview

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.

Impact of SMART GOAL Setting Protocol on Body Weight and Metabolic Parameters in Children and Adolescents With Prediabetes; a Randomized Clinical Trial.

SMART GOALS for Youth With Prediabetes

Condition
PreDiabetes
Intervention / Treatment

-

Contacts and Locations

New York

Northwell Health, New York, New York, United States, 11042

New York

Northwell Health, New York, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Children between ages 10-18 years at baseline visit
  • 2. Children with BMI for age and sex ≥ 85th percentile at baseline visit
  • 3. Children with hemoglobin A1c 5.7% to 6.4% at baseline visit
  • 1. Children who are not able to provide assent to the study
  • 2. Children less than 10 years in age
  • 3. Children that are not interested in weight loss or diet and lifestyle change
  • 4. 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).
  • 5. Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
  • 6. Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)
  • 7. Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis
  • 8. Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness
  • 9. Children with known or suspected eating disorders as identified through the electronic medical record
  • 10. Children that have known genetic or syndromic obesity
  • 11. Female children who are pregnant

Ages Eligible for Study

10 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Benjamin U. Nwosu, MD, PRINCIPAL_INVESTIGATOR, NORTHWELL HEALTH, INC.

Study Record Dates

2025-12-10