Mobile Physical Activity for Type 1 Diabetes

NCT04204733 | Completed

• 1 other identifier: 2000025992
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

• Moderate to vigorous physical activity (objective)

  Minutes per day assessed by hip accelerometry

  10 weeks

• Moderate to vigorous physical activity (subjective)

  Minutes per day assessed by workouts logged on mobile application

  10 weeks

Interventions

Mobile application BEHAVIORAL

Mobile application that incorporates biosensor feedback, teleconsultation, and online group physical activity classes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes or other insulin deficiency diabetes
• a. Diagnosed for at least six months
• Lower than recommended physical activity level for at least 2 months
• a. Defined as performing sustained moderate to vigorous physical activity (20min) on less than three days per week
• Own a smartphone
• Own a continuous glucose monitor with enough supplies for 10 weeks a. When available, we will provide these to those who do not own them, in which case they will be considered to meet this criteria

You may not qualify if:

• Chronic renal failure
• Class 3 obesity
• a. Defined as body mass index greater than 40 kg/m\^2
• Pregnancy
• Cognitive impairment
• Inability to read and/or understand English
• Severe retinopathy
• Neuropathy or nephropathy
• History of arrhythmia
• Myocardial infarction and (or) angina in past six months
• Other chronic disease or physical disability that would influence treatment intervention
• Other chronic disease or physical disability that would preclude participation in regular physical activity

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (2)

• Ash GI, Griggs S, Nally LM, Stults-Kolehmainen M, Jeon S, Brandt C, Gulanski BI, Spanakis EK, Baker JS, Whittemore R, Weinzimer SA, Fucito LM. Evaluation of Web-Based and In-Person Methods to Recruit Adults With Type 1 Diabetes for a Mobile Exercise Intervention: Prospective Observational Study. JMIR Diabetes. 2021 Jul 8;6(3):e28309. doi: 10.2196/28309.

  PMID: 34047700 RESULT

• Ash, G. I., Nally, L. M., Stults-Kolehmainen1, M. A., De-Los-Santos, M., Jeon, S., Brandt, C., Fucito, L. (2021, April 1). Personalized Big Data for Type 1 Diabetes Exercise Support. https://doi.org/10.31236/osf.io/34vdc

  RESULT

Related Links

• Evaluation of Web-Based and In-Person Methods to Recruit Adults with Type 1 Diabetes for a Technology-Based Exercise Intervention: Prospective Observational Study
• Personalized Big Data for Type 1 Diabetes Exercise Support

Study Officials

• Garrett Ash, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 19, 2019
• Study Start: January 6, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

US (1)