About this trial
Small Steps for Big Changes (SSBC) is a diet and exercise counselling program that significantly reduces the risk of developing Type 2 Diabetes (T2D). In partnership with YMCAs in Canada spanning 8 provinces, the aim of this study is to scale-up program delivery and evaluate the implementation and effectiveness of SSBC. To evaluate implementation, the number of staff trained/patients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program will be examined. To evaluate program effectiveness, changes in patient health (e.g., T2D status, blood glucose, weight, exercise, diet) will be measured over 2 years following program completion.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Community-dwelling adults aged 18 years or older
able to read and speak English
has prediabetes assessed by one of the following means: (a) physician-diagnosed prediabetes, (b) HbA1c values between 5.7 - 6.4% (American Diabetes Association, 2012), (c) an American Diabetes Association risk questionnaire score indicating increased risk (>5)
Individuals who have previously been diagnosed with type 2 diabetes but who are in remission (defined as achieving glycated hemoglobin (A1C) of < 6.4% without any diabetes-related medications for a minimum of 3 months) will be eligible to participate.
Disqualifiers
None
Trial population
The investigators aim to recruit a community-based sample of adults at risk of type 2 diabetes
Trial design
Cohort
Prospective
Treatments tested in this trial
Behavioural: Small Steps for Big Changes Diabetes Prevention Program
BehavioralThe 4-week behaviour change program will introduce participants to a regular healthy lifestyle including exercise and dietary changes for reducing sugar intake, reducing refined/processed carbohydrate intake, increasing vegetable consumption. The 4-week program will include six supervised exercise sessions and three exercise sessions performed independently (e.g., at home or outside of the YMCA). The supervised session will include brief behavioural counselling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercising and dietary changes.
Treatment groups
Trial outcomes
Primary outcomes
Type 2 diabetes status
Self reported HbA1c%
Change in HbA1c
Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants
Adoption of SSBC
Proportion and representativeness of coaches and implementation support team obtained through program records
Reach of SSBC
Proportion of patients' enrolled and completing the intervention, proportion of implementation staff trained and retained. Demographics of the patients and staff
Secondary outcomes
Change in body weight
Measured in pounds
Change in cardiorespiratory fitness
Distance walked in the six minute walk test will be conducted at sites with access to a walking track.
Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire
The Godin Leisure Time Physical Activity Questionnaire will be used to examine physical activity behaviour. Respondents report the frequency of strenuous, moderate, and mild physical activity for bouts of 15 or more minutes during a 7-day period. The scores are multiplied by weigths and summed into an overall score reports in metabolic equivalents of task (METs)/minutes of physical activity per week.
Changes in physical activity using the 2-item Physical Activity Vital Signs measure
The 2-item Physical Activity Vital Signs measure will be used to collect information on physical activity behaviour. Two questions are self-reported: 1) "How many days during the past week have you performed physical activity where your heart beats faster and your breathing is harder than normal for 30 minutes or more?" and 2) "How many days in a typical week do you perform activity such as this?" The responses are reported as days during the past week over days in a typical week, with scores ranging from 0 to 7 for each question.
Other outcomes
Organizational readiness
Organizational readiness for change measured by the Organizational Readiness for Implementing Change (Shea et al., 2014)
Change in 24-hour movement
Change in 24-hour movement will be examined using a 4-item measure to collect information on time spent in activity, sitting and sleeping in hours and minutes
Change in waist circumference
Measured at level of Iliac crest in centimetres by the coach
Baseline self-compassion
Patients' self-compassion will be assessed at baseline using the short form self-compassion scale (Raes et al., 2011). This 12-item measure has participants rate the extent to which they engage in certain behaviours on a 5-point response scale from 1 (almost never) to 5 (almost always). Sub scales can be computed by adding item scores. A total self-compassion score is computed.
Sponsors and contacts
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University of British Columbia
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Public Health Agency of Canada (PHAC)
Collaborator
McMaster University
Collaborator
Memorial University of Newfoundland
Collaborator
Brock University
Collaborator
Arthritis Research Centre of Canada
Collaborator