Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to address whether inactive individuals with prediabetes who take part in the Small Steps for Big Changes program, which is a 3-week supervised exercise and lifestyle change program with brief counseling, will be more adherent to regular exercise one year after program completion compared to before they took part in the program.

Detailed Description
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The study is a one-group repeated measures design and the primary outcome is exercise adherence at 12 months post the 3-week supervised exercise program. There is no randomization of individuals to conditions. Exercise adherence will be measured using self-report physical activity (using the Godin leisure time exercise questionnaire) and a subsample will also wear tri-axial accelerometers to measure total time spent in moderate-to-vigorous physical activity assessed over 7 days. Secondary outcomes include physical fitness, haemoglobin A1C, quality of life, self-regulatory efficacy, anthropometrics, diet and exercise-related cognitive errors. The 3-week lifestyle program includes six sessions with a lifestyle coach and exercise sessions performed at home. These sessions will focus on regular healthy lifestyle that includes walking (or exercise of any kind) at least three times per week and will highlight simple dietary strategies that are linked to reduced risk of T2D. The 3-week supervised exercise program includes brief exercise counseling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercise and a healthy diet. At the conclusion of the three-week program, participants will be asked to continue exercising a minimum of three times per week for twelve months on their own.

Official Title
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Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes in the Community

Conditions
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PreDiabetes

Intervention / Treatment
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* Behavioral: Lifestyle change


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ability to speak and read English BMI between 25-40 kg/m2 (as measured by body mass and height self-reporting), blood pressure of <160/99 mm Hg assessed according to CHEP guidelines, not diagnosed with type 2 diabetes no prior history of cardiovascular disease not on hormone replacement therapy Cardiovascular medications (e.g., statins) will be allowed if the participant is on stable therapy (6 months on same dose). Exclusion Criteria, if subjects: take glucose-lowering medications that have changed within the past 6 months; report any explicit contraindications to exercise (e.g., musculoskeletal injury, chest pain during exercise) report having had a heart attack or stroke in the past; report that they are pregnant or plan on becoming pregnant over the next 12 months; have uncontrolled major depression; have bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity which a physician has not cleared them for to exercise; report that a physician has not cleared their participant for exercise.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lifestyle change (one-treatment group)<br>The lifestyle change program is a 3-week program that will introduce participants to a regular healthy lifestyle that includes exercising at least three times per week and the program will highlight simple dietary strategies. There is no randomization to this program - all individuals enrolled will partake in the same program and will be followed up for 12 months after the program has concluded. | Behavioral: Lifestyle change<br>* The 3-week lifestyle 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 3-week program will include six supervised exercise sessions and three exercise sessions performed independently (e.g., at home or outside of the lab). The supervised session will include brief behavioral counseling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercising and dietary changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minutes of moderate to vigorous physical activity | objective measure of physical activity will be measured using tri-axial accelerometers in a subsample of  100 participants | change from before participants begin the program to 52 weeks after they finish the program for 7 consecutive days | 
| independent bouts of physical activity | self-reported measure of bouts of physical activity as assessed by the Godin Leisure Time Exercise Questionnaire | change from when participants begin the program to 52 weeks after they finish the program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose control | haemoglobin A1C | change from when participants begin the program to 52 weeks after they finish the program (week 55) | 
| Aerobic fitness | six-minute walk test | before the program begins (week 0), after the program is completed (week 3), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55) | 
| Perceived health-related quality-of-life | SF-12 Health Survey (Ware, Kosinski, & Keller, 1995) | before the program begins (week 0), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55) | 
| Self-regulatory efficacy for physical activity and diet | questionnaire | before the program begins (week 0), after the program is completed (week 3), 4-weeks after the completion of the program (week 7), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55) | 
| minutes of moderate to vigorous physical activity | objective measure of physical activity will be measured using tri-axial accelerometers in a subsample of  100 participants | 24 weeks after program completion (week 27) for 7 consecutive days | 
| independent bouts of physical activity | self-reported measure of bouts of physical activity as assessed by the Godin Leisure Time Exercise Questionnaire | 4- (week 7) and 24-weeks (week 27) after completion of the program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PreDiabetes, Lifestyle intervention, Exercise Behavior, Adherence