RECRUITING

SMART GOALS for Youth With Prediabetes

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-10

Study Completion:2025-12-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06067451

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.

Ages Eligible for Study:10 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Thomas Zachmann, RD

CONTACT

(516) 472-3750

tzachmann@northwell.edu

Rashida Talib, MPH

CONTACT

(516)472-3631

rtalib@northwell.edu

Principal Investigator

Benjamin U. Nwosu, MD

PRINCIPAL_INVESTIGATOR

NORTHWELL HEALTH, INC.

Study Locations (Sites)

Northwell Health

New York, New York, 11042

United States

Northwell Health

New York, New York, 11042

United States

Collaborators and Investigators

Sponsor: Northwell Health

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-10

Study Completion Date2025-12-10

Study Record Updates

Study Start Date2023-12-10

Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

Nutrition

Additional Relevant MeSH Terms

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