SMART GOALS for Youth With Prediabetes

Sponsor

Northwell Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06067451

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PreDiabetes Adolescent Obesity Behavior, Health Nutritional and Metabolic Diseases Diet Habit Lifestyle Risk Reduction	Behavioral: SMART GOALS Setting Tool/ Protocol	N/A

Detailed Description

Implementing a SMART goal-setting protocol for the overweight and obese pediatric population with prediabetes can benefit patients by empowering participants to set their own goals. In addition, utilizing a standardized tool can provide a more focused approach to behavior change between visits and increase a child's sense of self- efficacy and autonomy which may enhance motivation and engagement in the treatment process. This study can add strength to current interventions involving childhood obesity and prediabetes management and may inform the development of a more effective interventions in this population. By providing evidenced-based strategies, this study has the potential to improve the health of children at risk for type 2 diabetes.

The investigators will recruit 60 participants with newly diagnosed prediabetes to the proposed study.

Participants will be recruited from the outpatient clinic of the Children's Diabetes Center at the Cohen Children's Medical Center, Long Island, NY.

Participants will be randomized in a 1:1 ratio to one of the two arms. The participants will be stratified by Tanner stage (II and III vs IV and V) and sex (Male vs Female) before randomization.

The Medical Nutrition therapy (MNT) Protocol and visit frequency will be the same for all of the study participants in both the study and standard of care group in which the Registered Dietician (RD) will reinforce and encourage healthy habits and behaviors In addition successes and barriers to change.

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 the participants plan to improve on from now and their next visit: responses will be documented in the EMR, and participants will schedule a follow-up visit in 1-4 months.

The participant randomized in the study group 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 based on the latest literature recommendations. In addition, each domain will provide a list of examples of SMART goals for participants to choose from. Participants will be asked to independently select and personalize 2-3 SMART goals from this list.

The Registered Dietitian will identify the patient's perceived challenges in achieving their goal, work collaboratively with the patient to problem-solve and make necessary modifications to the goal to overcome challenges. The provider may suggest scaling back the goal if participant reports that perceived challenges are deemed to be significant or participants may choose to work on new goals or will intensify current goals as necessary at the end of each follow-up. The goal will be recorded in the WGMT for progress evaluation and monitoring. This tool should be returned at follow-up. The WGMT will be documented into the patients' chart and scanned into the Electronic Medical Record (EMR).

The study will evaluate changes in weight throughout the intervention by measuring participants anthropometric parameters, including height, weight, and BMI. These measurements will be taken at baseline, 1-4 months, and 4-7 months using the Touchbase Electronic medical record system, which will calculate BMI based on CDC growth charts adjusted for age and sex based.

To assess changes in metabolic parameters, routine laboratory data will be collected based on the discretion of the attending endocrinologist per the standard of care. This will include Hemoglobin A1c, lipid panel and blood pressure. The data will be used to evaluate changes in metabolic health over the course of the study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We'll enroll 60 pediatric subjects diagnosed with prediabetes within three months at the Pediatric Diabetes Clinic. These subjects will be randomly assigned to two arms. All participants will receive standardized medical nutrition therapy protocol and visit frequency from RD. Study group participants will get the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT). SGSG will outline three SMART goal domains (exercise, diet, behavior) with a primary goal and example goals. Participants will personalize 2-3 SMART goals, those in standard of care group will just be asked "what changes they plan to make".We'll enroll 60 pediatric subjects diagnosed with prediabetes within three months at the Pediatric Diabetes Clinic. These subjects will be randomly assigned to two arms. All participants will receive standardized medical nutrition therapy protocol and visit frequency from RD. Study group participants will get the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT). SGSG will outline three SMART goal domains (exercise, diet, behavior) with a primary goal and example goals. Participants will personalize 2-3 SMART goals, those in standard of care group will just be asked "what changes they plan to make".

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Oct 15, 2025

Anticipated Study Completion Date :

Dec 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
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).	Behavioral: 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.
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:

Arm

Intervention/Treatment

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).

Behavioral: 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.

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:

Outcome Measures

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 [6 months]
To determine the impact of SMART Goal setting on BMI z-scores, will assess anthropometrics at baseline, month 3 and at final visit (month 6)

Secondary Outcome Measures

Temporal changes in Hemoglobin A1c between the study and control groups [3 months]
A1c will be drawn every 3 months.
Temporal changes in Lipids [6 months]
Lipid panel to be drawn at baseline and again at 6 months if show elevation are detected per standard of care

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children between ages 10-18 years at baseline visit
Children with BMI for age and sex ≥ 85th percentile at baseline visit
Children with hemoglobin A1c 5.7% to 6.4% at baseline visit

Exclusion Criteria:

Children who are not able to provide assent to the study
Children less than 10 years in age
Children that are not interested in weight loss or diet and lifestyle change
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).
Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)
Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis
Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness
Children with known or suspected eating disorders as identified through the electronic medical record
Children that have known genetic or syndromic obesity
Female children who are pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Northwell Health

Investigators

Principal Investigator: Benjamin U. Nwosu, MD, NORTHWELL HEALTH, INC.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Northwell Health

ClinicalTrials.gov Identifier:

NCT06067451

Other Study ID Numbers:

23-0375

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 4, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Northwell Health

Nutrition

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023