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Evidence-Based Lifestyle Prescription Program: Pilot Study (HeSP)

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ClinicalTrials.gov Identifier: NCT02413385
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Robert Petrella, 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.

Condition or disease Intervention/treatment Phase
Chronic Disease Sedentary Lifestyle Overweight Behavioral: HealtheSteps Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: 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).
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Behavioral: HealtheSteps Program
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.

No Intervention: Usual-care wait-list control
No active intervention (usual care).



Primary Outcome Measures :
  1. Average steps per day [ Time Frame: 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 :
  1. Total physical activity (metabolic equivalent (MET)-minutes/week) [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    From the International Physical Activity Questionnaire - Short Version

  2. Time spent in sedentary activity (minutes/day) [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    From the International Physical Activity Questionnaire - Short Version

  3. Eating habits: Total healthful eating score [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured by Starting the conversation questionnaire

  4. Eating habits: Fruit and vegetable consumption [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured by the modified Dietary Instrument for Nutrition Education questionnaire

  5. Eating habits: Fatty food score [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured by the modified Dietary Instrument for Nutrition Education questionnaire

  6. Eating habits: sugary food consumption [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured by the modified Dietary Instrument for Nutrition Education questionnaire

  7. Health-related quality of life: self-rated health [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Visual Analogue Scale score measured using questionnaire known as EQ-5D-3L

  8. Resting systolic blood pressure [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured using automated blood pressure monitor

  9. Resting diastolic blood pressure [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured using automated blood pressure monitor

  10. Weight loss (absolute and percentage) [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured using digital weight scale

  11. Waist circumference [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Measured using tape measure

  12. Body mass index [ Time Frame: 6 months (plus 12 and 18 months in the intervention group only) ]
    Calculated from height (stadiometer) and weight (digital weight scale) measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413385


Locations
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Canada, Ontario
SJHC Family Medical Centre
London, Ontario, Canada, N6G 1J1
Sponsors and Collaborators
Western University, Canada
Public Health Agency of Canada (PHAC)
Investigators
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Principal Investigator: Robert J Petrella, MD, PhD University of Western Ontario, Lawson Health Research Institute
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Petrella, Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT02413385    
Other Study ID Numbers: HealtheSteps3
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Robert Petrella, Western University, Canada:
lifestyle intervention
physical activity
exercise
eHealth
technology
coaching
healthy eating
Additional relevant MeSH terms:
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Overweight
Chronic Disease
Body Weight
Disease Attributes
Pathologic Processes