Evidence-Based Lifestyle Prescription Program: Pilot Study
- Conditions
- Chronic DiseaseSedentary LifestyleOverweight
- Interventions
- Behavioral: HealtheSteps Program
- Registration Number
- NCT02413385
- Lead Sponsor
- Western University, Canada
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- 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)
- Unable to comprehend letter of information and consent documentation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HealtheSteps Program HealtheSteps Program 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).
- Primary Outcome Measures
Name Time Method Average steps per day 6 months (plus 12 and 18 months in the intervention group only) Measured over 7-day monitoring period using pedometers (Yamax Digiwalker SW200 model)
- Secondary Outcome Measures
Name Time Method Health-related quality of life: self-rated health 6 months (plus 12 and 18 months in the intervention group only) Visual Analogue Scale score measured using questionnaire known as EQ-5D-3L
Total physical activity (metabolic equivalent (MET)-minutes/week) 6 months (plus 12 and 18 months in the intervention group only) From the International Physical Activity Questionnaire - Short Version
Time spent in sedentary activity (minutes/day) 6 months (plus 12 and 18 months in the intervention group only) From the International Physical Activity Questionnaire - Short Version
Eating habits: Fatty food score 6 months (plus 12 and 18 months in the intervention group only) Measured by the modified Dietary Instrument for Nutrition Education questionnaire
Resting diastolic blood pressure 6 months (plus 12 and 18 months in the intervention group only) Measured using automated blood pressure monitor
Weight loss (absolute and percentage) 6 months (plus 12 and 18 months in the intervention group only) Measured using digital weight scale
Eating habits: Total healthful eating score 6 months (plus 12 and 18 months in the intervention group only) Measured by Starting the conversation questionnaire
Eating habits: Fruit and vegetable consumption 6 months (plus 12 and 18 months in the intervention group only) Measured by the modified Dietary Instrument for Nutrition Education questionnaire
Eating habits: sugary food consumption 6 months (plus 12 and 18 months in the intervention group only) Measured by the modified Dietary Instrument for Nutrition Education questionnaire
Resting systolic blood pressure 6 months (plus 12 and 18 months in the intervention group only) Measured using automated blood pressure monitor
Waist circumference 6 months (plus 12 and 18 months in the intervention group only) Measured using tape measure
Body mass index 6 months (plus 12 and 18 months in the intervention group only) Calculated from height (stadiometer) and weight (digital weight scale) measurements
Trial Locations
- Locations (1)
SJHC Family Medical Centre
🇨🇦London, Ontario, Canada