Reducing Sedentary Behaviour in Patients With Type II Diabetes

NCT03815955 | Completed

• 1 other identifier: 112907
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The study will implement a prospective one-arm feasibility study. After an initial eligibility screening by the primary care provider during their intake appointment, new patients will be invited to participate in an acute intervention to reduce sedentary behaviour during a group appointment at St. Joseph's Primary Care Diabetes Support (SJHC PCDSP). Scheduled with up to 10 other people, participants will be encouraged to model the primary care provider and support team as they engage in minimal sedentary behaviour and replace sitting with standing and light, incidental movements. An accelerometer-based sensory (ActivPAL4) will be worn and used to measure the patients' sedentary behaviour and physical activity patterns, including the duration and frequency of breaks in sedentary time during the appointment. Capillary blood glucose differences will be assessed at pre- and post-appointment. A series of paper-pencil questionnaires will also measure self-efficacy, goal intention, and positive and negative affect at both pre- and post-appointment.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (6)

• Frequency of Non-Sedentary Behaviour Breaks

  The frequency of breaks taken from engaging in sedentary behaviour recorded during the scheduled 1-hour appointment with the primary care provider will be measured using the ActivPAL4 monitor, a wearable device specifically designed for sedentary behaviour interventions. The ActivPAL4 can measure sitting/lying, standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.

  The ActivPAL4 will be worn during the whole 1-hour DIGMA, and will record the frequency of breaks during this time (60 minutes).

• Non-Sedentary Behaviour Break Time

  The duration of breaks (minutes) taken during the scheduled 1-hour appointment with the primary care provider will be measured using the ActivPAL4 monitor, a wearable device specifically designed for sedentary behaviour interventions. The ActivPAL4 can measure sitting/lying, standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.

  The ActivPAL4 will be worn during the whole 1-hour DIGMA, and will record the duration of breaks during this time (60 minutes).

• Capillary Blood Glucose

  Capillary blood glucose (mg/dl) of all participants will be measured by the research staff at both pre- and post-appointment using a Accu-chek Guide meter and test strips (glucometer).

  Capillary blood glucose differences will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).

• Self-efficacy

  Self-efficacy will be assessed using a scale adapted from the General Self-Efficacy Scale. Participants will rate their confidence to standing for 5 minutes during decreasing periods of time (i.e., +3 hours, 2 hours, 1 hour, \<1 hour). An example of one of the statements used will be "I believe that I can stand for 5 minutes every +3hours". Participants will also rate their confidence to standing and moving for increasing periods of time (i.e., 2 minutes, 5 minutes, 10 minutes, and 20 minutes) over a 2-hour time interval. An example of one of the statements used will be "I believe that I can stand and move for 2 minutes ever 2 hours".

  Self-efficacy will be self-measured at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).

• Goal Intentions

  Goal intentions will be measured through the completion of a questionnaire along three dimensions: respondents will refer to a specific point in time, to the place, and to the degree of behavioral intent that is linked to the situational context specified by time and place. An example of one of the statements used will be "Over the next week, I intend to stand more at home". Subjects will then indicate using a 5-point Likert scale the degree to which they endorse this statement (e.g., 1 is not at all to 5 is completely agree).

  Goal intentions will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).

• Positive and Negative Affect

  Positive and negative affect will be self-reported using the 20-item questionnaire, Positive and Negative Affect Schedule (PANAS).

  Positive and negative affect will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).

Study Arms (2)

Non-Sedentary Behaviour Group

EXPERIMENTAL

Participants in this arm will model the primary care team as they engage in minimal sedentary behaviour and replace sitting with standing and light, incidental movements.

Behavioral: Non-Sedentary Behaviour Modelling

Standard Care Control Group

NO INTERVENTION

Participants that are limited to standing, due to amputations, diabetic foot pain and ulcers, or sensory diabetic neuropathy, will follow standard care and attend the DIGMA in a seated position.

Interventions

Non-Sedentary Behaviour Modelling BEHAVIORAL

Consistent with social learning theory, the primary care provider and the DIGMA support team will model, demonstrate, and verbalize aspects of increased confidence to perform the 1-hour appointment in a standing position and offer a variety of strategies to cope and overcome any feelings of discomfort. Emphasis will be placed on the strategies the primary care team uses to break sitting with standing and light, incidental movements. It will be anticipated that the participant will observe cues and relevant information specific to their behaviour change and engage in minimal sedentary behaviour.

Non-Sedentary Behaviour Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants, aged 18 years or older, will be eligible if they present diagnostic criteria according to the Diabetes Canada 2018 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada for type 2 diabetes (diagnosed by any of the following criteria: glycated hemoglobin (A1C) ≥6.5%, fasting plasma glucose (FPG) ≥7.0 mmol/L, 2-hour plasma glucose (2hPG) in a 75 g oral glucose tolerance test (OGTT) ≥11.1 mmol/L, random PG ≥11.1 mmol/L) and would benefit from a DIGMA.

You may not qualify if:

• Individuals with diabetes will be excluded if they are younger than 18 years, have significant illness, or an inability to communicate in English.

Sponsors & Collaborators

• Western University, Canada: lead
• St. Joseph's Health Care London: collaborator

Study Sites (2)

University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

St. Joseph's Family Medical and Dental Centre

London, Ontario, N6G 1J1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Sedentary Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Harry Prapavessis, PhD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 25, 2019
• Study Start: March 14, 2019
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CA (2)