Wearable Technology and a Virtual Lifestyle Program for Type 2 Diabetics

NCT04498819 | Completed

• 1 other identifier: 116071
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The Primary Care Diabetes Support Program (PCDSP) offers a lifestyle medicine program, STAND, that patients can self-select themselves to participate. STAND offers biweekly, one-hour educational classes. With the onset of COVID-19, the clinic has moved virtually, but has yet to offer an individualized exercise program. Little evidence is available on utilizing telemedicine and wearable technologies combined in a clinical exercise setting. This is a 6-week single cohort prospective study assessing the feasibility of incorporating wearable activity trackers and individualized exercise prescriptions in the PCDSP's virtually delivered, STAND program in an adult population with type 2 diabetes mellitus. Roughly 15-20 participants will be recruited. Participants will attend the bi-weekly STAND classes and track their step counts daily using FitBits, trying to achieve individually prescribed step counts. Participants receive a brief follow up phone call every other week. The primary outcomes assessed will be recruitment and retention rates, as well as acceptability of, and adherence to, the virtual program. Acceptability will be assessed by an exit survey and mean number of reported technological issues. Adherence will be number of classes attended and percent of days with FitBit worn (\>500 steps) and average percent Libre sensor is active. Change in self-efficacy levels, diabetes emotional related distress, exercise volume, glucose control and fitness levels will secondarily be assessed.

Conditions

Type 2 Diabetes; Comorbidities and Coexisting Conditions

Keywords

wearable activity trackers; exercise prescription; lifestyle medicine; virtual care; remote monitoring; behavioural economics; social norms; continuous blood glucose monitoring

Outcome Measures

Primary Outcomes (4)

• Feasibility: Recruitment

  Recruitment levels will be defined as the number of people signed up over number of eligible people approached at intake and in class, presented as a percentage of sign up rates.

  from the date of of the first participant recruited the last participant recruited for the study (estimated last date for recruitment cut off is November 14th, 2020; allowing for study data collection completion by December 18, 2020).

• Feasibility: Retention

  Retention will be calculated as number of participants completed post-intervention follow-up assessment divided by initial sample size.

  From time of consent and up to 9 weeks later (study completion)

• Feasibility: Acceptability

  Acceptability will be assessed from participant feedback from the exit survey. Acceptability data gathered from the exit survey will be analyzed in a qualitative or descriptive fashion, using frequencies and means (i.e. "this many rated the lottery draw as a motivation to get them to attend class as "strongly agree": 93%"). Technical difficulties will be dealt with (by contact) and recorded by the Master's student in the STAND-VAT activity log. Number of reported technology issues will be reported as a total in addition to average mean # of technology issues per person. Counting will be used based on type of issue using categories like: a) lost/disrupted internet connection or unable to connect or hear or see during class; b) issues utilizing FitBit/FitBit app c) Issues with uploading FitBit data; d) other. Difficulty assessment will provide insight for improvements for larger future studies.

  Week 1 of intervention up to time of follow up (7 weeks later)

• Feasibility: Adherence

  Adherence will be assessed by the percent of biweekly classes attended and check-in phone calls answered, as well as number of data submissions (all out of three) as well as monitor adherence: percent of days with FitBit worn (\>500 steps) and average percent Libre sensor is active.

  Week 1 of intervention to week 6

Secondary Outcomes (9)

• Participant Behaviour; Exercise Behaviours: Daily Step Count

  1-week Baseline to end of week 6 of intervention (total 7 weeks assessed)

• Participant Behaviour; Exercise Behaviours: Daily Sedentary Time

  1-week Baseline to end of week 6 of intervention (total 7 weeks assessed)

• Participant Behaviour; Exercise Behaviours: Exercise Prescription Adherence

  week 1 to week 6 of intervention

• Glycemic Control Measures: Time in Glycemic Target

  Weekly assessment from week 1 to week 6 of intervention

• Glycemic Control Measures: Estimated A1c

  Weekly assessment from week 1 to week 6 of intervention

Study Arms (1)

Single Arm

EXPERIMENTAL

Only one arm, one intervention; this is a feasibility study.

Behavioral: Wearable Activity Trackers, Exercise Prescription and Virtual Care

Interventions

Wearable Activity Trackers, Exercise Prescription and Virtual Care BEHAVIORAL

The intervention is merging wearable activity trackers and tailored aerobic exercise prescriptions into the PCDSP's virtual STAND (a biweekly, evidence based, lifestyle medicine) program. Participants will wear activity trackers for a week to collect baseline step data (used to create tailored step prescriptions). Biweekly, new step prescriptions will be tailored to each participant based on the previous two week's step count data. The intervention will add onto STAND classes by using activity tracker data into the class discussion for learning opportunities, as well as goal setting and action planning. The day of class, participants will receive a summary email new prescription and encouragement to continue to work hard, using the previous weeks' data to reinforce motivation. The activity tracker will provide instant feedback about step goals, sedentary behaviour and exercise minutes. Individual calls every other week will ensure adherence to exercise regime.

Single Arm

Eligibility Criteria

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

You may qualify if:

• a new patient intake at the PCDSP,
• ≥18 years old,
• ability to communicate in English,
• diagnosis of T2D ,
• declared interest in participating in the STAND-VAT study,
• interest in using wearable technology,
• medically cleared to participate in exercise,
• ownership of a smartphone and able to have Internet connection. The smartphone must be either iPhone 7 (with an iOS of 12.2 or higher) or Android operating system 5 or higher to allow for FitBit© and LibreView mobile application compatibility,
• ownership of a laptop or desktop computer,
• access to Internet connection.

You may not qualify if:

• Inability to participate in the full 6-week program,
• active or recent (within 12-weeks) foot ulcer(s),
• unstable blood pressure,
• unstable blood sugars including recurrent hypo/hyperglycemia,
• untreated retinopathy,
• unstable cardiovascular disease (CVD),
• pregnancy,
• or unstable psychiatric disease limiting group participation.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

SJHC Primary Care for Diabetes Support Program

London, Ontario, N6G 1J1, Canada

Location

Related Publications (1)

• Hiemstra MS, Reichert SM, Mitchell MS. Examining a Remote Group-Based Type 2 Diabetes Self-Management Education Program in the COVID-19 Era Using the ORBIT Model: Small 6-Week Feasibility Study. JMIR Form Res. 2024 Jan 29;8:e46418. doi: 10.2196/46418.

  PMID: 38285502 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marc S Mitchell, PhD

  Western University

  PRINCIPAL INVESTIGATOR

• Sonja Reichert, MD MSc CCFP

  SJHC Primary Care for Diabetes Support Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will be a 6-week single cohort prospective feasibility study. The study will involve a total of nine weeks of involvement time, one week of study set-up, one week of baseline, six weeks of intervention time, and in the eighth week a follow-up survey and fitness test. There is one condition; participants are self-selecting themselves to be a part of this intervention being offered, in addition to the usual care offered at the PCDSP clinic.

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 5, 2020
• Study Start: November 9, 2020
• Primary Completion: April 2, 2021
• Study Completion: May 7, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)