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

Trial Summary

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 data supports the effectiveness of the SMART Goals Setting Tool/Protocol treatment for childhood prediabetes?

Research shows that setting SMART goals can help improve diabetes management, as seen in a study where patients with diabetes who set SMART goals had better control of their blood sugar levels compared to those who did not. This suggests that using SMART goals for childhood prediabetes might also help in managing the condition effectively. ^{1 2 3 4 5}

Is the SMART Goals approach safe for managing diabetes in children?

The available research does not specifically address the safety of the SMART Goals approach for managing diabetes in children, but it suggests that setting SMART goals in diabetes management may lead to fewer medication changes and improved diabetes control, which implies a positive safety profile. ^{1 6 7 8 9}

How does the SMART Goals treatment for childhood prediabetes differ from other treatments?

The SMART Goals treatment for childhood prediabetes is unique because it focuses on youth-directed goal setting to improve self-management and glycemic control, which is not well-characterized in existing treatments. This approach emphasizes personalized goal setting and self-regulation, potentially offering a novel way to manage prediabetes in children compared to standard medical treatments. ^{6 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Benjamin Nwosu, MD

Principal Investigator

NORTHWELL HEALTH, INC.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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 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 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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of SMART Goals on Diabetes Management in a Pharmacist-Led Telehealth Clinic. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An Educational Intervention to Increase Nurse Adherence in Eliciting Patient Daily Goals. [2015]

3. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of goal-setting on glycemic control in poor outpatients with diabetes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A 'SMART' way to determine treatment goals in pharmacotherapy education. [2022]

5. England 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. [2022]

6. Denmark 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. [2022]

7. Denmark 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Self-monitoring of blood glucose by adolescents with diabetes: technical skills and utilization of data. [2017]

9. Ireland pubmed.ncbi.nlm.nih.gov

Assessment of blood glucose self-monitoring skills in a camp for diabetic children: the effects of individualized feedback counselling. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Pilot Study of a Web-Delivered Multicomponent Intervention for Rural Teens with Poorly Controlled Type 1 Diabetes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Diabetes self-care goals and their relation to children's metabolic control. [2022]

12. United States 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. [2021]

13. United States 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. [2023]