Small Steps for Big Changes - Healthy Cities Implementation Science

ConditionPreDiabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Behavioural: Small Steps for Big Changes Diabetes Prevention Program

    Behavioral

    The 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

4,400 Participants
are divided into 1 treatment group
Group A: Small Steps for Big Changes: Diabetes Prevention Program1 intervention

Trial outcomes

Primary outcomes

1

Type 2 diabetes status

Self reported HbA1c%

Time frame
0, 12, and 24 months post intervention
2

Change in HbA1c

Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants

Time frame
0, 12 and 24 months post intervention
3

Adoption of SSBC

Proportion and representativeness of coaches and implementation support team obtained through program records

Time frame
0, 52, 104, 156, 208 weeks
4

Reach of SSBC

Proportion of patients' enrolled and completing the intervention, proportion of implementation staff trained and retained. Demographics of the patients and staff

Time frame
0, 52, 104, 156, 208 weeks

Secondary outcomes

1

Change in body weight

Measured in pounds

Time frame
0, 4, 52, and 104 weeks
2

Change in cardiorespiratory fitness

Distance walked in the six minute walk test will be conducted at sites with access to a walking track.

Time frame
0, 4, 52, and 104 weeks
3

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.

Time frame
0, 4, 52, and 104 weeks
4

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.

Time frame
0, 4, 52, and 104 weeks

Other outcomes

1

Organizational readiness

Organizational readiness for change measured by the Organizational Readiness for Implementing Change (Shea et al., 2014)

Time frame
0 weeks
2

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

Time frame
0, 4, 52, 104 weeks
3

Change in waist circumference

Measured at level of Iliac crest in centimetres by the coach

Time frame
0, 4, 52, and 104 weeks
4

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.

Time frame
0 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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