Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT06067451

Conditions

PreDiabetes

Adolescent Obesity

Behavior, Health

Nutritional and Metabolic Diseases

Diet Habit

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

SMART GOALS Setting Tool/ Protocol

Study Details

Brief summary:

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

Study ID

NCT06067451

Start date

Dec 10, 2023

Status verified date

Dec, 2023

Completion date

Dec 10, 2025

Anticipated

Primary completion date

Nov 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: SMART GOAL Arm

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).

no intervention: Standard of Care Arm

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:

Interventions

SMART GOALS Setting Tool/ Protocol

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 participant will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for.

Primary outcome measure

  • To determine the impact of SMART Goal setting on BMI z-scores To determine the impact of SMART Goal setting on BMI z-scores [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Northwell Health

Recruiting

New York, New York, United States, 11042

Contacts

Principal Investigator:

Benjamin Nwosu, MD

Northwell Health

Recruiting

New York, New York, United States, 11042

More Information

Sponsor

Northwell Health

Last update posted

Dec 14, 2023

Last verified

Dec, 2023

Keywords

  • Nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-12-14.