ActivateDoes a Behavior Change Skills and Physical Activity Program Improve Self-regulation and Health Outcomes in Adolescents With Type 1 Diabetes?
Diabetes behavior change skills training
+ Physical activity promotion program
Enfermedades del Sistema Endocrino+4
+ Enfermedades Autoinmunes
+ Diabetes Mellitus
Estudio de Tratamiento
Resumen
Fecha de inicio: 18 de abril de 2022
Fecha en la que se inscribió al primer participante.Adolescents with type 1 diabetes and socioeconomic disadvantage experience significant health disparities in glycemic outcomes in adolescence and cardiovascular disease and diabetes-related death later in adulthood. Socioeconomic disadvantage is associated with elevated glycosylated hemoglobin (HbA1c) and 3x risk of repeat hospitalizations for diabetic ketoacidosis as well as 2-3x risk of cardiovascular disease and diabetes-related death. Suboptimal glycemic outcomes are a powerful determinant of long-term health complications and costs, with a 1% reduction in HbA1c contributing to up to a 40% reduction in risk for later nephropathy, retinopathy, and macrovascular disease. Given the substantial health disparities for persons with type 1 diabetes and socioeconomic disadvantage and the many challenges that adolescents face with achieving optimal glycemic levels (<20% nationally meet American Diabetes Association HbA1c targets), this is a critical population to support in health behavior change via psychosocial intervention during adolescence. Unfortunately, existing evidence-based psychosocial type 1 diabetes interventions for adolescents, including robust multi-system approaches, have demonstrated limited efficacy for behavior change that results in improved glycemic outcomes and none have directly targeted cardiovascular health outside of glycemic outcomes. In this project, the researchers pursue a new avenue for intervention innovation by testing a nationally-scalable diabetes behavior-change skills training and physical activity intervention program to improve glycemic outcomes and decrease cardiovascular disease risks for adolescents with type 1 diabetes including those with socioeconomic disadvantage . In this study the researchers will conduct a two-arm randomized trial with 30 adolescents with type 1 diabetes, comparing the 12-week Activate program to a treatment-as-usual control group. This study has 2 primary aims. First, the investigators will assess acceptability of the Activate program by examining participant engagement with the Activate program components. To assess the preliminary efficacy of the Activate program the investigators will examine changes in proximal outcomes of behavior-change skills (goal setting, problem-solving, and coping skills), and active minutes compared between treatment and control groups from baseline to a 12-week follow-up assessment. Second, the investigators will explore the impact of the Activate program on secondary mechanisms and outcomes linked with longer-term type 1 diabetes health disparities.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 31 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 13 a 17 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación