Personalized Exercise for Adolescents With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to determine the likely benefits of a study that would use the novel
      techniques both of writing an exercise "prescription" and of including the family and/or
      community in sticking to the exercise prescription by youths with diabetes, who often suffer
      eventual cardiovascular complications that might be lessened by the exercise.
    

Detailed description: 
      Diabetes mellitus (DM) is now the sixth leading cause of death in the U.S., primarily due to
      cardiovascular (CV) complications. People with DM have a 2 to 4 times increased risk for
      heart disease. An increasing number of adolescents are diagnosed with DM, predisposing them
      to CV morbidity and mortality in early adulthood. Using a comparison group pretest-posttest
      design, the Primary Aim of this investigation is to determine the feasibility of conducting a
      novel personalized exercise prescription (PEP) intervention with 20 adolescents who have type
      1 DM and 20 adolescents with type 2 DM. We will explore the influence of DM-specific family
      social support, exercise self-efficacy, and benefits and barriers to exercise on adherence to
      PEP. The Secondary Aim is to explore possible changes in physiological (i.e.,
      cardiorespiratory fitness, heart rate variability, metabolic control, and lipid profile) and
      psychological outcomes (i.e., diabetes quality of life [QOL]) of the PEP intervention in
      adolescents with type 1 or type 2 DM. Long-term benefits of exercise for persons with DM
      include decreased risk factors for CV disease, improved well-being, and increased life
      expectancy. The current decline in physical activity during adolescence is problematic,
      particularly for those with DM, who have an added risk for future CV disease. The limited
      research available on the efficacy of exercise interventions with youths who have type 1 DM
      indicates improvements in cardiorespiratory fitness, lipid profile, and glucose regulation.
      No published exercise intervention research with adolescents who have type 2 DM is available.
      However, exercise interventions with overweight youth have shown increased heart rate
      variability and cardiorespiratory fitness. Although numerous studies have examined various
      school-based strategies to promote more physically active lives in youth populations, no
      studies have examined the feasibility of conducting individualized, culturally focused
      exercise prescriptions for adolescents with type 1 or type 2 DM that incorporate family
      support in a home or community setting. Nor have studies addressed the possible psychosocial
      and physiological outcomes of these personalized approaches. This investigation will extend
      the principal investigator's program of research that identified differences in CV risks for
      adolescents with type 1 vs. type 2 DM. Determining factors that influence the conduct and
      outcomes of individualized exercise interventions for adolescents with DM can potentially
      lead to the development of programs that promote adherence to exercise, avert complications,
      and improve QOL and overall health.
    

Intervention name(s): PEP intervention
Intervention type(s): Behavioral
Intervention description(s): This study will explore the feasibility of adherence to a personalized exercise prescription (PEP) in adolescents with type 1 or type 2 diabetes. The PEP intervention consists of a 2-hour group education session and a 16-week personalized exercise plan implemented in the home or community setting with the use of parental support and care ambassadors. Care ambassadors will maintain consistency of interactions with specific families for the duration of the PEP intervention. This consistency will aid in establishing rapport with the adolescents and parents to answer any questions and provide guidance for adhering to the PEP plan. The PEP intervention will be mutually planned with each teen and parent based upon the assessment of the teen's personal and cultural choices, including family and community resources. Exercise frequency, duration, and intensity for the teen with diabetes will be documented with a MTI ActiGraph accelerometer (Fort Walton Beach, FL).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Diabetes; Exercise