Evidence-Based Lifestyle Prescription Program: Pilot Study

Study Overview
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Brief Summary
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The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle prescription (Rx) program, supported by in-person coaching and innovative health technologies. The program improves the health of Canadians and reduces their risk for chronic disease by tackling three major risk factors that are shared across a number of chronic diseases: physical inactivity, sedentary behaviour and poor diet. Each HeS participant receives an individualized healthy living Rx for exercise, physical activity (step counts) and healthy eating, supported by coaching and technology tools to promote long-term health behaviour change. For this study, the investigators will undertake a 6-month pilot pragmatic randomized controlled trial (RCT), conducted within 5 clinic settings in Southwestern Ontario. The primary aim is to conduct an outcome evaluation to determine the effectiveness of the HeS program in helping at-risk individuals increase physical activity levels, improve eating habits, and improve other health behaviours and health indicators.

Detailed Description
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The HealtheSteps™ (HeS) program was developed to improve the health of Canadians and reduce their risk for chronic disease (CD) and brings together emerging evidence from the areas of physical activity, nutrition, behaviour change, health technologies, and knowledge transfer, and moves knowledge into practice. HeS is an evidence-based, viable, and scalable healthy lifestyle solution to tackle the epidemic of CD in Canada. HeS goes beyond traditional health promotion messaging to give individuals a specific plan of action to improve their health and provides community settings with hands-on training, and resources from study knowledge brokers (KBs) to facilitate program uptake and sustainability. The investigators suggest that a widely available HeS program has the potential to impact the lives of Canadians at-risk for and living with CD; shift practice patterns within Family Health Teams (FHTs), Community Health Centres (CHCs) and clinics; reduce health care costs associated with CD; and inform policy decisions about health resource allocation and human resource planning. A scaled-up HeS program will offer at-risk Canadians an opportunity to actively participate in an evidence-based, community-focused, affordable (no cost to participant), healthy lifestyle program supported by point-of-care coaching and innovative electronic Health (eHealth) technologies. This study will use a two-arm, pilot pragmatic randomized controlled trial (RCT) design. It will take place within 5 clinic settings in Southwestern Ontario. Following assessment of eligibility and baseline measurements, participants will be individually randomized (1:1; stratified by clinical setting) to either the intervention group (receiving the HeS program) or to the comparison group (usual care wait-list control). The comparison group will be offered to start the HeS program after a 6 month delay. All participants (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. Measurements will be taken at baseline and 6 months in both groups; additional follow-up measurements will be taken in the intervention group only at 12 months and again at 18 months (from baseline). Groups will be compared at 6-months in order to examine effectiveness of the HeS program; further, follow-up to 12 and 18 months will be used to look at maintenance of any changes in the intervention group only.

Official Title
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Canadian Diabetes Strategy Research Project - HealtheSteps™: Exercise and Healthy Eating Prescriptions to Reduce the Risk of Diabetes in Rural and Remote Communities: A Pilot Pragmatic Randomized Controlled Trial (Project 3).

Conditions
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Chronic Disease, Sedentary Lifestyle, Overweight

Intervention / Treatment
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* Behavioral: HealtheSteps Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One or more self-reported or measured risk factors for chronic disease including: a) objectively-measured body-mass index of greater than or equal to 25 kg/m2; b) less than 150 minutes of exercise per week; c) greater than 3 hours of sitting per day; d) less than 8 fruit and vegetable servings per day; e) diagnosis of metabolic syndrome or type 2 diabetes Clear Physical Activity Readiness Questionnaire (PAR-Q) (i.e., either by answering No to all questions or receiving clearance from a healthcare provider) Exclusion Criteria: Unable to comprehend letter of information and consent documentation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HealtheSteps Program<br>6 month evidence-based lifestyle Rx program: receive lifestyle Rx's for exercise, physical activity (step counts) and healthy eating and set goals around Rx's (in person sessions at set time points during 6-month period); take part in self-directed healthy living activities to achieve Rx's (Months 0-6); access to a suite of health technology support options for additional support and coaching (Months 0-6). | Behavioral: HealtheSteps Program<br>* 6-month evidence-based lifestyle Rx program: At set time points over the 6-month period, participants have in-person visits with a HeS coach at the clinic setting. At each in-person session, the participant receives an individualized Rx for exercise, physical activity (step count) and healthy eating. The HeS Coach and participant then engage in a coaching/goal setting conversation to set detailed plans and goals to achieve their prescriptions. Participants independently choose which activities they will take part in to achieve their lifestyle Rx's and goals. In between in-person sessions, the participants have access to a suite of free-of-charge health technology support tools to: a) track their exercise, physical activity, and healthy eating; and b) receive virtual coaching and support.<br>|
| No Intervention: Usual-care wait-list control<br>No active intervention (usual care). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average steps per day | Measured over 7-day monitoring period using pedometers (Yamax Digiwalker SW200 model) | 6 months (plus 12 and 18 months in the intervention group only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total physical activity (metabolic equivalent (MET)-minutes/week) | From the International Physical Activity Questionnaire - Short Version | 6 months (plus 12 and 18 months in the intervention group only) | 
| Time spent in sedentary activity (minutes/day) | From the International Physical Activity Questionnaire - Short Version | 6 months (plus 12 and 18 months in the intervention group only) | 
| Eating habits: Total healthful eating score | Measured by Starting the conversation questionnaire | 6 months (plus 12 and 18 months in the intervention group only) | 
| Eating habits: Fruit and vegetable consumption | Measured by the modified Dietary Instrument for Nutrition Education questionnaire | 6 months (plus 12 and 18 months in the intervention group only) | 
| Eating habits: Fatty food score | Measured by the modified Dietary Instrument for Nutrition Education questionnaire | 6 months (plus 12 and 18 months in the intervention group only) | 
| Eating habits: sugary food consumption | Measured by the modified Dietary Instrument for Nutrition Education questionnaire | 6 months (plus 12 and 18 months in the intervention group only) | 
| Health-related quality of life: self-rated health | Visual Analogue Scale score measured using questionnaire known as EQ-5D-3L | 6 months (plus 12 and 18 months in the intervention group only) | 
| Resting systolic blood pressure | Measured using automated blood pressure monitor | 6 months (plus 12 and 18 months in the intervention group only) | 
| Resting diastolic blood pressure | Measured using automated blood pressure monitor | 6 months (plus 12 and 18 months in the intervention group only) | 
| Weight loss (absolute and percentage) | Measured using digital weight scale | 6 months (plus 12 and 18 months in the intervention group only) | 
| Waist circumference | Measured using tape measure | 6 months (plus 12 and 18 months in the intervention group only) | 
| Body mass index | Calculated from height (stadiometer) and weight (digital weight scale) measurements | 6 months (plus 12 and 18 months in the intervention group only) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle intervention, physical activity, eHealth, technology, coaching, healthy eating, exercise