Behavioral Intervention for Type 1 Diabetes

(EMPoWER Trial)

Overseen By Marisa Hilliard, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Cancer, Cystic fibrosis, Psychiatric, others

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

Compensation: Varies

Number of Visits: 4

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help young people with type 1 diabetes improve blood sugar control, daily habits, and overall well-being. Youth participants and their parents will use an app and watch Teen Videos (behavioral intervention videos) to learn diabetes management by focusing on their strengths. The study aims to determine if these activities make a difference compared to receiving regular diabetes information. Children aged 10 to 13 with type 1 diabetes for at least six months and a recent high blood sugar reading (hemoglobin A1c ≥ 8%) might be suitable candidates. As an unphased trial, this study offers families a unique opportunity to explore innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on behavioral interventions rather than medication changes.

What prior data suggests that this behavioral intervention is safe for youth with type 1 diabetes?

Research shows that videos are generally well-received by teens with type 1 diabetes. Previous studies have found that similar video programs do not cause significant side effects or safety issues. These videos aim to help teens manage their diabetes by offering educational content in a fun and engaging way.

Although specific safety data for the "Teen Videos" treatment in this trial is not available, educational videos are a common and safe method in behavioral studies. Designed to support self-care without physical risks, these videos offer a low-risk option for helping young people improve their diabetes management skills. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Intervention for Type 1 Diabetes trial because it offers a fresh approach to managing diabetes through a family-centered, app-based program. Unlike traditional methods that often rely solely on medication and regular monitoring, the T1DW Program incorporates daily app activities and engaging videos to help both parents and kids recognize and celebrate positive diabetes management behaviors. This strengths-based approach, paired with goal-setting and discussions with healthcare providers, aims to create a supportive environment that empowers young patients and their families. The focus on behavioral change and family involvement could lead to improved diabetes management and overall well-being for young patients.

What evidence suggests that this trial's behavioral intervention could be effective for type 1 diabetes?

Research shows that educational and behavioral programs can help children and teens with type 1 diabetes understand their condition and improve self-care. In this trial, participants will be randomized to either the Type 1 Doing Well (T1DW) Program or the Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC). Studies have found that online programs for teens can lead to better results, especially when completed. Videos specifically designed for young people, included in the T1DW Program, aim to enhance communication with doctors and boost confidence in managing diabetes. Overall, these behavioral programs for teens with type 1 diabetes have moderately improved blood sugar control and self-care. This suggests that incorporating videos into these programs could help young people and their parents manage diabetes more effectively. ^{1 5 6 7 8}

Who Is on the Research Team?

Marisa Hilliard, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for English-speaking teens aged 14-17 living in the US with type 1 diabetes for at least a year. It's not suitable for those with major psychiatric or developmental disorders, or serious medical conditions like cancer or cystic fibrosis.

Inclusion Criteria

Living in the United States

I have had type 1 diabetes for at least a year.

I am between 14 and 17 years old.

Exclusion Criteria

I do not have major health issues like cancer or cystic fibrosis.

I do not have any major psychiatric or developmental disorders that would affect my ability to consent or participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation and Randomization

Parent-youth dyads complete an orientation session and are randomized to their study arm

1 week

1 visit (in-person or virtual)

Intervention

Participants engage in the T1DW Program or EUC Program for 6 months, involving app-based activities or monthly handouts

6 months

Monthly activities (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including satisfaction surveys and other assessments

6 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Teen Videos

Trial Overview

The EMPoWER study is creating and testing teen-focused videos as part of a new behavioral intervention to help young people manage type 1 diabetes effectively alongside their parents.

How Is the Trial Designed?

Group I: Type 1 Doing Well (T1DW) Program Experimental Treatment 1 Intervention

Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the T1DW Program at the orientation session, parents and youth will receive an overview of the web-based mobile application and intervention activities that they will engage with for 6 months. The app-based intervention activities include brief daily use of the app for parents to recognize and reinforce their child's positive diabetes-related behaviors, brief weekly activities for parents and youth to reflect on and discuss what the child has done well for diabetes, family diabetes goal-setting, and videos for parents and youth about living well with T1D. Parents and youth will also engage in a brief strengths-based conversation with their diabetes care provider at one medical appointment during the study period.

Group II: Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC) Active Control 1 Intervention

Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the EUC Program at the orientation session, parents and youth will receive monthly email handouts with diabetes-related information and resources for 6 months.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

Published Research Related to This Trial

Behavioral interventions for adolescents with type 1 diabetes show a small- to medium-sized beneficial effect on diabetes management, with an overall mean effect size of 0.33 based on a systematic review of 35 studies, including 24 randomized control trials.

Interventions grounded in theoretical frameworks were significantly more effective than those without such foundations, highlighting the importance of a solid theoretical basis in designing effective diabetes management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for adolescents with type 1 diabetes: how effective are they? Hampson, SE., Skinner, TC., Hart, J., et al.[2022]

Behavioral self-management programs for individuals with type 1 diabetes showed a moderate reduction in glycated hemoglobin (HbA1c) levels at 6 months compared to usual care, indicating short-term benefits for glycemic control.

However, at the end of the intervention and after 12 months, there were no significant differences in HbA1c levels or quality of life compared to usual care, suggesting that the long-term efficacy of these programs may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Programs for Type 1 Diabetes Mellitus: A Systematic Review and Meta-analysis. Pillay, J., Armstrong, MJ., Butalia, S., et al.[2022]

Educational videos for diabetes management can lead to a statistically significant reduction in HbA1C levels, with decreases ranging from -0.1% to -2.1% in several studies, indicating improved blood sugar control.

Participants reported positive feedback on the videos, highlighting the importance of cultural appropriateness and representation, which suggests that tailored educational content can enhance self-care and management of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of videos for diabetes patient education: A systematic review. Hoe, CYW., Ahmad, B., Watterson, J.[2023]

Psychologists play a crucial role in diabetes care teams by providing psychological and behavioral interventions that help youth with Type 1 and Type 2 diabetes manage their condition, improve their quality of life, and achieve better glycemic control.

The article highlights the importance of tailored interventions that consider individual and family needs, and emphasizes the need for integrating behavioral health into routine diabetes care to enhance the effectiveness of treatment for both Type 1 and Type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based behavioral interventions to promote diabetes management in children, adolescents, and families. Hilliard, ME., Powell, PW., Anderson, BJ.[2022]

A brief 2.5-day psycho-educational intervention for people with Type 1 diabetes did not significantly change HbA1c levels or the incidence of severe hypoglycaemia over 12 months, indicating limited efficacy in these primary outcomes.

However, the intervention did lead to improved treatment satisfaction and patient empowerment, as evidenced by significant improvements in related psychometric measures at 3, 6, and 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of a brief educational intervention in Type 1 diabetes: results from the BITES (Brief Intervention in Type 1 diabetes, Education for Self-efficacy) trial. George, JT., Valdovinos, AP., Russell, I., et al.[2022]

The Pediatric Education for Type 1 Diabetes (T1D) project, involving 24 children aged 6 to 16 over 12 months, effectively improved knowledge, self-management skills, and overall wellbeing in young patients with Type 1 diabetes.

The study highlights the importance of a multidisciplinary approach, including collaboration between pediatric and adult diabetologists, to enhance the quality of care and support during the transition from childhood to adulthood in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured therapeutic education program for children and adolescents with type 1 diabetes: an analysis of the efficacy of the "Pediatric Education for Diabetes" project. Mauri, A., Schmidt, S., Sosero, V., et al.[2022]

Educational interventions for children with type 1 diabetes effectively improve diabetes knowledge but do not consistently lead to better metabolic control, based on a review of 41 studies published between 1980 and 1999.

Psychosocial interventions, particularly coping skills training and peer support, are beneficial for adolescents in improving their adjustment to diabetes and can sometimes enhance metabolic control, while family interventions help reduce conflicts between parents and children regarding diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for children with diabetes and their families. Grey, M.[2019]

A study analyzing 50 posts from diabetes online forums revealed that teens with type 1 diabetes prioritize not only blood glucose management but also peer interactions and emotional well-being, highlighting the multifaceted nature of their concerns.

The research suggests that healthcare providers should consider these broader outcomes—like emotional support and social interactions—when developing interventions to help teens manage their diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes That Matter to Teens With Type 1 Diabetes. Ye, CY., Jeppson, TC., Kleinmaus, EM., et al.[2018]

The study developed interactive games to educate children with type-1 diabetes about managing their condition, focusing on the relationship between food, glucose levels, exercise, and insulin.

Out of 58 testers, over 90% found the games entertaining and engaging, with around 60% believing they offered a more appealing educational experience compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Edutainment tools for initial education of type-1 diabetes mellitus: initial diabetes education with fun. Aoki, N., Ohta, S., Masuda, H., et al.[2022]

Mobile technology interventions, particularly text messages, have been commonly used to support adolescents with type 1 diabetes, but the evidence for their effectiveness in significantly improving glycemic control (measured by HbA1c) is mixed, with only three out of thirteen studies showing a notable decrease.

Interventions that include data collection and clinician support features may enhance adherence and glycemic control, but the overall evidence for mobile applications is weak, indicating a need for higher quality studies to better inform future designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using mobile technology to motivate adolescents with type 1 diabetes mellitus: A systematic review of recent literature. Deacon, AJ., Edirippulige, S.[2022]

The review highlights the importance of addressing behavioral barriers in managing diabetes in children and adolescents, emphasizing that effective interventions can improve treatment adherence and metabolic control.

Validated assessment methods for diabetes-specific behavioral issues, such as fears, social skills, and stressors, are crucial for tailoring interventions that support better health outcomes in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral assessment and intervention in pediatric diabetes. Wysocki, T.[2007]

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Teenagers & Diabetes: Can't Miss Tips for Growing Up with T1D

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