Evidence-Based Lifestyle Prescription Program: Pilot Study
Condition: Chronic Disease; Sedentary Lifestyle; Overweight
MeSH terms: Overweight; Chronic Disease
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): HealtheSteps Program
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: lifestyle intervention; physical activity; exercise; eHealth; technology; coaching; healthy eating