- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204733
Mobile Physical Activity for Type 1 Diabetes
May 3, 2021 updated by: Yale University
Mobile Approaches to Promote Physical Activity in Type 1 Diabetes
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.
Study Overview
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).
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate to vigorous physical activity (objective)
Time Frame: 10 weeks
|
Minutes per day assessed by hip accelerometry
|
10 weeks
|
Moderate to vigorous physical activity (subjective)
Time Frame: 10 weeks
|
Minutes per day assessed by workouts logged on mobile application
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Garrett Ash, PhD, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2020
Primary Completion (Actual)
November 12, 2020
Study Completion (Actual)
November 12, 2020
Study Registration Dates
First Submitted
December 16, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 19, 2019
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 3, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000025992
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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