Mobile Physical Activity for Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study is the formative observation stage of behavioral intervention development.
      Sedentary adults with type 1 diabetes will be given access to a mobile application that
      incorporates biosensor feedback, teleconsultation, and online group exercise classes. The
      first aim is to quantify the feasibility, acceptability, and preliminary efficacy of the
      application. The second aim is to evaluate predictors and mechanisms of physical activity
      behavior change among these adults. The possible predictors the investigators are monitoring
      include usage of specific application features, momentary internal factors (e.g.,
      pre-activity fear of hypoglycemia), momentary external factors (e.g., location), and latent
      external factors (e.g., mental health traits). These results will be used to develop a
      refined mobile application utilizing the most popular application features, as well as an
      algorithm that uses the identified predictors of physical activity to advise adults with type
      1 diabetes when to engage in physical activity (i.e., context-aware physical activity
      coaching) and when to make related diet and insulin adjustments.
    

Detailed description: 
      People with type 1 diabetes (T1D), which includes ~1 million American adults, have an 8-fold
      higher risk of mortality attributable to cardiovascular disease than those in their decade
      cohort. Current evidence-based T1D self-management interventions target cardiovascular risk
      by improving glycemic control, but do not effectively address other modifiable risk factors
      prevalent in T1D such as hypertension, dyslipidemia and obesity. Thus, T1D interventions that
      are effective for a broader range of health targets than glycemic control are urgently
      needed. Moderate to vigorous physical activity (MVPA) interventions could provide a novel
      solution, but only if they can attenuate the unique barriers to MVPA posed by T1D: 1)
      insufficient knowledge of insulin pharmacokinetics to self-manage and prevent unpredictable
      blood glucose fluctuations during MVPA; 2) fear of MVPA-induced hypoglycemia; and 3) lack of
      perceived social support for T1D. The present study is conducting formative research to guide
      the development of such an intervention incorporating the latest advances in diabetes
      science: 1) continuous glucose monitors; 2) teleconsultation; 3) peer group MVPA classes; and
      4) context-aware diabetes self-management coaching algorithms. The study represents stage #0
      (basic science) of the NIH Stage Model for Behavioral Intervention Development. Specifically,
      the investigators will conduct a longitudinal, observational study in people with T1D who
      receive a 10-week mobile intervention that incorporates biosensor feedback, teleconsultation,
      and online group PA classes. Participants will be followed for 10 weeks to evaluate
      intervention acceptability and identify potential mechanisms of PA behavior change. The
      expected outcome of this study is preliminary data for the investigators' future direction of
      an NIH Small Business Technology Transfer grant application to refine this intervention (NIH
      Stage Model Stage 1). Specifically, the investigators will utilize the most popular
      components from the observational study and also develop an algorithm that uses identified
      predictors of PA to advise patients on timing and preparation for PA. This refined
      intervention will be pilot tested, then optimized and tested for efficacy using an advanced
      trial design (such as multiphase optimization strategy) among a larger sample (NIH Stage
      Model Stage 2).
    

Intervention name(s): Mobile application
Intervention type(s): Behavioral
Intervention description(s): Mobile application that incorporates biosensor feedback, teleconsultation, and online group physical activity classes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care