Behavioral Intervention for Type 1 Diabetes (EMPoWER Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Baylor College of Medicine
No Placebo Group
Trial Summary
What is the purpose of this trial?The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact.
In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents, the study is first enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will be used in the intervention materials for the randomized clinical trial.
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on a behavioral intervention, so it's likely you can continue your current diabetes medications.
What data supports the idea that Behavioral Intervention for Type 1 Diabetes is an effective treatment?The available research shows that behavioral interventions, such as coping skills training and peer support, help adolescents with Type 1 Diabetes improve their adjustment to the condition and sometimes improve their metabolic control. These interventions are part of a broader approach that includes educational and family-focused strategies. While educational interventions mainly increase diabetes knowledge, behavioral interventions are more effective in promoting self-management and improving quality of life. Additionally, mobile technology like text messages and apps can be useful tools for delivering these interventions to adolescents.12678
Is the treatment in the trial 'Behavioral Intervention for Type 1 Diabetes' a promising treatment?Yes, behavioral interventions are promising for managing Type 1 Diabetes. They help young people and their families stick to their diabetes care routines, improve their quality of life, and prevent complications. These interventions can include skills training, family support, and using mobile technology to motivate and educate.24689
What safety data exists for the behavioral intervention for Type 1 Diabetes?The provided research does not directly address safety data for the behavioral intervention using videos for Type 1 Diabetes. However, the systematic review on educational videos for diabetes patients indicates positive outcomes such as improved health literacy, self-efficacy, and a decrease in HbA1C levels, with generally positive feedback from participants. This suggests that the intervention is well-received and potentially effective, but specific safety data is not mentioned.3561011
Eligibility Criteria
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
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.
Participant Groups
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.
4Treatment groups
Experimental Treatment
Active Control
Group I: Type 1 Doing Well (T1DW) ProgramExperimental Treatment1 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: Teen VideosExperimental Treatment1 Intervention
All participants in the teen video phase of this project will make brief videos about living well with type 1 diabetes. Guidance will be provided about requirements for the videos. Participants may make up to 4 brief videos. The videos will be used in the upcoming clinical trial of the new behavioral intervention.
Group III: Diabetes Care ProviderExperimental Treatment1 Intervention
Diabetes care providers will deliver the provider portion of the intervention and will also be enrolled as study participants.
Group IV: Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)Active Control1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Baylor College of MedicineHouston, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
Children's National Research InstituteCollaborator
References
Interventions for children with diabetes and their families. [2019]The purpose of this review is to examine the research literature on interventions for children with type 1 diabetes and their families, with a specific focus on three types of intervention (educational and psychosocial/behavioral interventions that focus on individuals with diabetes and family interventions for families, usually parents, of individuals with diabetes). The aim of the review is to determine what interventions produce what outcomes in what populations of children and families. The review includes articles that met the following criteria: (a) empirical study reporting the impact of an intervention on such outcomes as knowledge, behavior, self-care, and metabolic control; (b) children with type 1 diabetes and/or their families as primary subjects; (c) publication between 1980 and January 1, 1999; and (d) publication in English. A total of 41 published papers were included. On the basis of this review, conclusions are as follows: (a) Educational interventions are useful in improving diabetes knowledge but not consistently helpful in improving metabolic control; (b) psychosocial interventions, especially coping skills training and peer support, assist primarily adolescents to improve adjustment and sometimes metabolic control; and (c) family interventions may be helpful in reducing parent-child conflict about diabetes management and care.
Behavioral interventions for adolescents with type 1 diabetes: how effective are they? [2022]To evaluate the effectiveness of behavioral interventions for adolescents with type 1 diabetes based on a systematic review of the literature.
Edutainment tools for initial education of type-1 diabetes mellitus: initial diabetes education with fun. [2022]Appropriate initial education for type-1 diabetes mellitus patients is important to prevent late complications. However, type-1 diabetic children have not appreciated traditional learning methods since they rarely contain the elements of fun and interactivity. In this study, we developed, implemented and evaluated a preliminary version of edutainment tools for initial education for type-1 diabetic children.
Behavioral assessment and intervention in pediatric diabetes. [2007]This article reviews the empirical research literature on behavioral assessment and intervention methods in the context of diabetes mellitus in children and adolescents. The review summarizes the pathophysiology, medical management, and monitoring of pediatric type 1 and type 2 diabetes. Next, the article describes common behavioral barriers to acceptable diabetes management and adequate metabolic control and the role of behavior change agents in evaluation and intervention for these problems. Validated approaches to the assessment of diabetes-specific behavioral problems are described for the measurement of treatment adherence, diabetes-related fears and avoidance behaviors, diabetes-specific social skills, and disease-related stressors. Behavioral interventions that have empirical support are discussed, including treatments that target treatment adherence, social skills, coping skills, family communication and problem solving, anxiety and stress management, and weight control. The article concludes with clinical practice recommendations for behavior change specialists who have the opportunity to work with this population.
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. [2022]Intensive 5-day educational interventions for people with Type 1 diabetes have shown improved outcomes in a number of European studies. The aim was to assess the effectiveness of a brief (2.5 days) psycho-educational intervention.
Using mobile technology to motivate adolescents with type 1 diabetes mellitus: A systematic review of recent literature. [2022]Behavioural interventions have been shown to improve outcomes in patients with type 1 diabetes mellitus (T1DM). There are a small number of studies that suggest text-messages (TM), native mobile applications (NMAs), and other mobile tools may be useful platforms for delivering behavioural interventions to adolescents.
Behavioral Programs for Type 1 Diabetes Mellitus: A Systematic Review and Meta-analysis. [2022]Whether behavioral approaches for self-management programs benefit individuals with type 1 diabetes mellitus is unclear.
Evidence-based behavioral interventions to promote diabetes management in children, adolescents, and families. [2022]As members of multidisciplinary diabetes care teams, psychologists are well-suited to support self-management among youth with Type 1 diabetes (T1D) and Type 2 diabetes (T2D) and their families. Psychological and behavioral interventions can promote adherence to the complex and demanding diabetes care regimen, with the goals of promoting high quality of life, achieving optimal glycemic control, and ultimately preventing disease-related complications. This article reviews well-researched contemporary behavioral interventions to promote optimal diabetes family- and self-management and health outcomes in youth with T1D, in the context of key behavioral theories. The article summarizes the evidence base for established diabetes skills training programs, family interventions, and multisystemic interventions, and introduces emerging evidence for technology and mobile health interventions and health care delivery system interventions. Next steps in behavioral T1D intervention research include tailoring interventions to meet individuals' and families' unique needs and strengths, and systematically evaluating cost-effectiveness to advocate for dissemination of well-developed interventions. Although in its infancy, this article reviews observational and intervention research for youth with T2D and their families and discusses lessons for future research with this population. Interventions for youth with T2D will need to incorporate family members, consider cultural and family issues related to health behaviors, and take into account competing priorities for resources. As psychologists and behavioral scientists, we must advocate for the integration of behavioral health into routine pediatric diabetes care in order to effectively promote meaningful change in the behavioral and medical well-being of youth and families living with T1D and T2D. (PsycINFO Database Record
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. [2022]Therapeutic education for Type 1 Diabetes involves the process of transmitting knowledge and developing the skills and behavior required to treat the disease. guidelines agree on stressing the importance of therapeutic educational intervention in teaching self-management skills to children and adolescents with Type 1 Diabetes (T1D). This study presents the results of the "Pediatric Education for Type 1 Diabetes (T1D)" (PED) project, specifically designed for children and adolescents aged 6 to 16, and structured on guidelines indications, as part of a broader clinical-educational intervention for Type 1 diabetes.
Outcomes That Matter to Teens With Type 1 Diabetes. [2018]Purpose The purpose of the study was to describe outcomes that matter to teens with type 1 diabetes. Understanding outcomes that matter to teens could support successful interventions to improve diabetes self-management. Methods Fifty publicly available posts published in the "teen" sections of 2 major diabetes online forums between 2011 and 2013 were analyzed using qualitative research methods. From each post, content and descriptive data (eg, duration of diabetes and age) were collected. Two members of the research team independently used open coding techniques to identify outcomes (defined as impacts or consequences of type 1 diabetes) and organized them into themes and subthemes. A codebook was jointly developed to facilitate the identification of meaningful outcomes from the posts. Results Teens' average age was 15.7 years, and the average time since diabetes diagnosis was 6.3 years. The 3 most commonly mentioned outcomes were (1) interactions with peers ("I want to talk to someone who understands"), (2) emotional well-being ("Diabetes makes me want to cry"), and (3) blood glucose management ("My blood sugar never goes down"). Other identified outcomes included (4) physical well-being, (5) education and motivation of others, (6) family interactions, (7) academic achievement, and (8) interactions with important others such as teachers. Conclusions While teens are concerned about control of their blood glucose, there are many other outcomes that matter to them. Health care providers and diabetes educators may want to consider these other outcomes when motivating teens with type 1 diabetes to improve blood glucose control.
The use of videos for diabetes patient education: A systematic review. [2023]Diabetes prevalence is rising worldwide, calling for public health concerns and interventions to improve prevention and management. Self-care is an important component in reducing the incidence of complications from diabetes, but it must be taught. This systematic review aims to synthesise the evidence for education videos for people with diabetes. Electronic databases, including Ovid (Medline, Embase, EmCare), PsychInfo, CINAHL, Web of Science and Scopus, were searched for studies on educational videos for patients with diabetes that met the inclusion criteria. A total of 36 studies met the inclusion criteria. Data extracted were synthesised through narrative synthesis. Studies examined outcomes including biological (i.e., glycated haemoglobin (HbA1C), weight, BMI), non-biological (health literacy, self-efficacy) and subjective feedback (i.e., acceptability, cultural appropriateness). The most common length of video was ≤10 min. Online dissemination was the most common method of video distribution. A statistically significant decrease (ranging from -0.1% to -2.1%) in HbA1C was noted in 7 of 12 studies examining this outcome. Other studies also found evidence of improvement in health literacy, self-efficacy, physical activity, medication adherence and other outcomes. Feedback from participants was generally positive, and emphasis was placed on the need for cultural appropriateness and representation in the educational videos.