Reducing Sedentary Behaviour in Patients With Type II Diabetes

NCT ID: NCT03815955

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2019-04-25

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.

Detailed Description

Following pre-screening at their intake appointment, if appropriate for a DIGMA and eligible to participate, new patients to SJHC PCDSP will be invited to attend a DIGMA scheduled two-weeks post-intake appointment. Participants will provide their written informed consent and patient demographic information, assessed by questionnaire, during the first hour of their appointment. With a trained research assistant, the participant will complete a series of behavioural measures including: the Godin Leisure-Time Exercise Questionnaire (GLTEQ) and a modified Sedentary Behaviour Questionnaire (SBQ). Standardized anthropometric measurements, including waist circumference, weight, height, and capillary blood glucose, of all participants will also be completed separately in an exam room.

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 models 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.

The frequency of breaks and the duration of breaks taken during the scheduled DIGMA will be measured using an ActivPAL4 monitor, a wearable device that can measure sitting/lying, standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.

Capillary blood glucose will be measured by the research staff at both pre- and post-appointment using a glucometer. As patients are not required to restrict their diet before a standard DIGMA, there will be no restrictions on food and/or drink intake before/during the morning of, the travel to, and/or during the appointment. Participants will be asked to self-report the time and what they ate during their last meal in their demographics questionnaire.

Self-efficacy and positive and negative affect will be self-reported at both pre- and post-appointment using a scale adapted from the General Self-Efficacy Scale and the Positive and Negative Affect Schedule (PANAS), respectively. As well, goal intentions of the patients will be measured using a questionnaire along three dimensions: respondents will refer to a specific point in time, to the place, and to the degree of behavioural intent that is linked to the situational context specified by time and place. An example of one of the questions will be "Over the next week, do you intend to sit less 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).

Conditions

Diabetes; Diabetes Mellitus, Type 2; Sedentary Lifestyle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Non-Sedentary Behaviour Group

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.

Group Type: EXPERIMENTAL

Non-Sedentary Behaviour Modelling

Intervention Type: 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.

Standard Care Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-Sedentary Behaviour Modelling

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Joseph's Health Care London

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Dr. Harry Prapavessis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harry Prapavessis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Locations

University of Western Ontario

London, Ontario, Canada

St. Joseph's Family Medical and Dental Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

112907

Identifier Type: -

Identifier Source: org_study_id