SMART Goals for Childhood Prediabetes

Overseen By Rashida Talib, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Must not be taking: Insulin, Metformin, Antidepressants, others

Disqualifiers: Diabetes, Psychiatric disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how setting SMART goals (Specific, Measurable, Attainable, Realistic, Time-sensitive) can help obese children with prediabetes improve their health. The study compares two groups: one using the SMART Goal Setting Protocol and another receiving standard care. Researchers aim to determine if the SMART protocol leads to better weight management, improved blood sugar levels, and healthier cholesterol. Children struggling with obesity and prediabetes (a condition with slightly elevated blood sugar levels) might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance health outcomes for children with prediabetes.

Will I have to stop taking my current medications?

The trial requires that participants do not take medications that alter glucose or lipid metabolism, such as insulin, metformin, or statins, and those that can alter body weight, like antidepressants or steroids. If you are on these medications, you may not be eligible to participate.

What prior data suggests that this SMART Goal Setting Protocol is safe for children with prediabetes?

Research has shown that SMART Goals are generally safe for use. These goals help individuals set clear and achievable steps to manage health conditions. SMART stands for Specific, Measurable, Attainable, Realistic, and Time-sensitive. This method guides lifestyle changes, like improving diet and exercise, which typically carry no risks or side effects.

No evidence indicates negative effects from using SMART Goals. As a tool for setting personal goals, it lacks the risks associated with medications or medical procedures. Participants in previous studies used SMART Goals to improve their health without reported problems. This suggests the method is safe and well-tolerated, even for children with prediabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART Goals Setting Tool/Protocol for childhood prediabetes because it offers a personalized approach to managing the condition. Unlike standard treatments that focus on general lifestyle advice and monitoring, this protocol helps kids set and track specific, achievable goals tailored to their individual needs. By using tools like the SMART Goal Selection Guide and Weekly Goal Monitoring Tool, this method empowers young patients to take an active role in their health, potentially improving their outcomes and fostering long-term healthy habits.

What evidence suggests that the SMART Goal Setting Protocol is effective for childhood prediabetes?

Research shows that the SMART Goals Setting Protocol, provided to participants in the SMART GOAL Arm of this trial, helps people change habits and improve health, particularly for those with diabetes. Studies have found that setting goals that are specific, measurable, achievable, relevant, and time-bound can lead to lasting lifestyle changes. These goals support better control of body weight and health indicators like blood sugar levels (measured by Hemoglobin A1c) and cholesterol. Evidence also suggests that working with a coach to set SMART Goals can significantly improve weight management. Overall, this method is a helpful strategy in diabetes care, making it a promising option for children with prediabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin Nwosu, MD

Principal Investigator

NORTHWELL HEALTH, INC.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child's A1c level is between 5.7% and 6.4%.

My child's BMI is in the top 15% for their age and sex.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SMART Goal Setting Protocol (SGSP) or standard of care, with regular monitoring of weight and metabolic parameters

6 months

Visits every 1-4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SMART GOALS Setting Tool/ Protocol

Trial Overview 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.

How Is the Trial Designed?

Group I: SMART GOAL Arm Experimental Treatment 1 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 Arm Active Control 1 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:

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

Children with Type I diabetes clearly differentiate between self-selected (want to do) and imposed (told to do) health-care goals, indicating distinct cognitive representations of their diabetes management activities.

While self-selected goals did not significantly impact metabolic control (measured by HbA1c levels), two of the three imposed goals were found to contribute significantly to better metabolic outcomes, suggesting that external guidance may be more effective in managing diabetes in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes self-care goals and their relation to children's metabolic control. Karoly, P., Bay, RC.[2022]

In a study of 111 children and adolescents with type 1 diabetes, the MiniMed™ 780G system effectively achieved key glycemic control targets, with 72.1% of participants maintaining time in range (TIR) above 70% after 6 months.

Factors such as older age and shorter duration of diabetes were linked to better glucose control, suggesting that personalized training may be beneficial for younger patients and those with longer disease duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiniMed 780G Six-Month Use in Children and Adolescents with Type 1 Diabetes: Clinical Targets and Predictors of Optimal Glucose Control. Lombardo, F., Passanisi, S., Alibrandi, A., et al.[2023]

After an educational intervention, nurses' adherence to writing SMART collaborative goals significantly improved from 11% to 63%, indicating enhanced goal-setting skills.

Patients reported feeling better informed by their healthcare providers, with perceptions increasing from 57% to 91% post-education, suggesting that improved goal-setting practices positively impacted patient communication and understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Educational Intervention to Increase Nurse Adherence in Eliciting Patient Daily Goals. Revello, K., Fields, W.[2015]

The implementation of SMART criteria significantly improved medical students' ability to set treatment goals, with the SMART group scoring 68.5% compared to only 29.6% and 30.8% for the WHO and control groups, respectively, in a study involving 251 second-year medical students.

Students using SMART criteria also demonstrated better treatment monitoring skills, scoring 34.2% compared to 19.3% and 24.6% in the other groups, highlighting the effectiveness of structured goal-setting in enhancing treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 'SMART' way to determine treatment goals in pharmacotherapy education. Tichelaar, J., Uil den, SH., Antonini, NF., et al.[2022]

The web-delivered intervention for 15 teens with poorly controlled type 1 diabetes was feasible and led to significant improvements in self-monitoring of blood glucose (SMBG) and reductions in HbA1c levels after 25 weeks.

Improvements in executive functioning, particularly in working memory and inhibitory control, were observed, and these cognitive enhancements correlated with better SMBG and lower HbA1c, indicating a positive impact on diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of a Web-Delivered Multicomponent Intervention for Rural Teens with Poorly Controlled Type 1 Diabetes. Lansing, AH., Stanger, C., Budney, A., et al.[2022]

The Type 1 Doing Well app was found to be feasible and highly acceptable among parents of adolescents with type 1 diabetes, with 91% of parents using it at least twice a week and high satisfaction ratings.

While the app did not show significant differences in clinical outcomes like HbA1c in this pilot study, it has the potential to enhance diabetes management when integrated into a broader intervention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes. Hilliard, ME., Cao, VT., Eshtehardi, SS., et al.[2021]

In a study of 58 adolescents, the overall technical accuracy of self-monitoring of blood glucose (SMBG) was 82%, with common errors including not cleaning fingers and incorrect blood placement on strips.

A follow-up questionnaire with 64 adolescents revealed that while most performed daily SMBG, many did not consistently record their results or use the data for self-management, indicating a need for better training and strategies to improve data utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-monitoring of blood glucose by adolescents with diabetes: technical skills and utilization of data. Delamater, AM., Davis, SG., Bubb, J., et al.[2017]

In a study of 122 youth with type 1 diabetes over 18 months, combining goal setting for blood glucose monitoring, continuous glucose monitoring, and insulin dosing was linked to a significant reduction in HbA1c levels by 0.4%.

Focusing solely on blood glucose monitoring or insulin dosing without integrating other related behaviors did not show any significant impact on HbA1c, highlighting the importance of a comprehensive approach to goal setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of youth goal setting in the self-management of type 1 diabetes and associations with HbA1c: The Flexible Lifestyle Empowering Change trial. Cristello Sarteau, A., Crandell, J., Seid, M., et al.[2022]

In a study of 100 patients with Type 2 diabetes, those who set SMART goals achieved a clinically meaningful reduction in A1c levels, with a 1.2% decrease compared to 0.85% in the control group, although the difference was not statistically significant (P = .287).

Patients who set SMART goals also experienced fewer medication changes (1.7 changes per patient) compared to those who did not set goals (2.1 changes), suggesting that SMART goals may help in managing diabetes more effectively during telehealth visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of SMART Goals on Diabetes Management in a Pharmacist-Led Telehealth Clinic. Cook, HE., Garris, LA., Gulum, AH., et al.[2022]

In a study involving 2062 adolescents with diabetes, clear and consistent glycaemic targets set by diabetes teams were strongly linked to better HbA1c outcomes, indicating that effective target setting is crucial for managing diabetes in adolescents.

The research found that both adolescents and parents' perceptions of ideal HbA1c levels correlated with actual HbA1c results, suggesting that aligning expectations with clinical targets can positively influence metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Target setting in intensive insulin management is associated with metabolic control: the Hvidoere childhood diabetes study group centre differences study 2005. Swift, PG., Skinner, TC., de Beaufort, CE., et al.[2022]

In a study involving 71 children and adolescents at a diabetic summer camp, 41 participants exhibited significant errors in blood glucose self-monitoring, indicating a need for improved accuracy in their testing methods.

Feedback counseling sessions aimed at correcting monitoring errors showed only marginal improvements, suggesting that the main issue with blood glucose monitoring was more related to attitude than a lack of knowledge or skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of blood glucose self-monitoring skills in a camp for diabetic children: the effects of individualized feedback counselling. Wolanski, R., Sigman, T., Polychronakos, C.[2019]

The study demonstrated that a goal-setting program for glycemic control in poor outpatients led to a significant reduction in HbA1c levels by 1.16%, indicating improved blood sugar management.

Providing glucometers for self-monitoring at no cost, combined with goal-setting, proved to be a feasible and cost-effective intervention for enhancing glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of goal-setting on glycemic control in poor outpatients with diabetes. Guo, HL., Wu, ZM., Yu, DM.[2022]

Parents of children with Type 1 diabetes often set blood glucose and HbA1c goals that align closely with their perceptions of physicians' goals, indicating a strong influence of healthcare provider communication on parental expectations.

Lower HbA1c goals set by parents are significantly associated with lower actual HbA1c levels in their children, suggesting that clear and aligned goal-setting between parents and healthcare providers could improve glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of blood glucose and HbA(1c) goals on glycaemic control in children and adolescents with Type 1 diabetes. Boot, M., Volkening, LK., Butler, DA., et al.[2022]

Citations

1. ctv.veeva.com ctv.veeva.com/study/smart-goals-for-youth-with-prediabetes

SMART GOALS for Youth With Prediabetes The goal of this study is to compare the impact of a SMART ((specific, measurable, attainable, realistic, or timely) Goal setting protocol ...

2. hopkinsmedicine.org hopkinsmedicine.org/all-childrens-hospital/services/healthy-weight-toolkit/tools/smart-goals

SMART Goals - Healthy Weight Toolkit SMART stands for Specific, Measurable, Achievable, Results-focused, and Time-Bound. Here is a breakdown of each section: Specific: Goals should be simple and ...

3. samhsa.gov samhsa.gov/sites/default/files/nc-smart-goals-fact-sheet.pdf

Setting Goals and Developing Specific, Measurable, ... SMART stands for specific, measurable, achievable, relevant, and time-bound. • Specific – Objective clearly states, so anyone reading it can understand, what ...

4. researchgate.net researchgate.net/profile/Carla-Miller-4/publication/262927816_Goal_Setting_An_Integral_Component_of_Effective_Diabetes_Care/links/553e332f0cf2522f1835fd50/Goal-Setting-An-Integral-Component-of-Effective-Diabetes-Care.pdf

Goal Setting: An Integral Component of Effective Diabetes ... Goal setting is recognized as an evidence-based strategy for promoting behavioral change in the National Standards for Diabetes Self-Management. Education and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7518513/

Personalizing the Dietary Guidelines: Use of a feedback ... Evidence suggests that developing a SMART Goal via shared decision-making between participant and coach can be highly effective in weight management and ...

6. diabetescarecommunity.ca diabetescarecommunity.ca/living-well-with-diabetes-articles/smart-goals-for-diabetes-management/

SMART Goals For Diabetes Management SMART goals provide a structured framework for individuals with diabetes, healthcare professionals, and support networks to collaborate effectively in crafting ...

7. ucop.edu ucop.edu/local-human-resources/_files/performance-appraisal/How+to+write+SMART+Goals+v2.pdf

SMART Goals: A How to Guide When setting a goal, be specific about what you want to accomplish. ... Data collection efforts needed to measure a goal can be included in that goal's action.