Evidence-Based Lifestyle Prescription Program: Pilot Study

NCT02413385 | Completed

• 1 other identifier: HealtheSteps3
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease; Sedentary Lifestyle; Overweight

Keywords

lifestyle intervention; physical activity; exercise; eHealth; technology; coaching; healthy eating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Total physical activity (metabolic equivalent (MET)-minutes/week)

  6 months (plus 12 and 18 months in the intervention group only)

• Time spent in sedentary activity (minutes/day)

  6 months (plus 12 and 18 months in the intervention group only)

• Eating habits: Total healthful eating score

  6 months (plus 12 and 18 months in the intervention group only)

• Eating habits: Fruit and vegetable consumption

  6 months (plus 12 and 18 months in the intervention group only)

• Eating habits: Fatty food score

  6 months (plus 12 and 18 months in the intervention group only)

Study Arms (2)

HealtheSteps Program

EXPERIMENTAL

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

Usual-care wait-list control

NO INTERVENTION

No active intervention (usual care).

Interventions

HealtheSteps Program BEHAVIORAL

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.

HealtheSteps Program

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unable to comprehend letter of information and consent documentation

Sponsors & Collaborators

• Western University, Canada: lead
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (1)

SJHC Family Medical Centre

London, Ontario, N6G 1J1, Canada

Location

Related Publications (13)

• Petrella RJ, Koval JJ, Cunningham DA, Paterson DH. Can primary care doctors prescribe exercise to improve fitness? The Step Test Exercise Prescription (STEP) project. Am J Prev Med. 2003 May;24(4):316-22. doi: 10.1016/s0749-3797(03)00022-9.

  PMID: 12726869 BACKGROUND

• Petrella RJ, Lattanzio CN, Demeray A, Varallo V, Blore R. Can adoption of regular exercise later in life prevent metabolic risk for cardiovascular disease? Diabetes Care. 2005 Mar;28(3):694-701. doi: 10.2337/diacare.28.3.694.

  PMID: 15735210 BACKGROUND

• Petrella RJ, Lattanzio CN, Overend TJ. Physical activity counseling and prescription among canadian primary care physicians. Arch Intern Med. 2007 Sep 10;167(16):1774-81. doi: 10.1001/archinte.167.16.1774.

  PMID: 17846397 BACKGROUND

• Petrella RJ, Lattanzio CN, Shapiro S, Overend T. Improving aerobic fitness in older adults: effects of a physician-based exercise counseling and prescription program. Can Fam Physician. 2010 May;56(5):e191-200.

  PMID: 20463260 BACKGROUND

• Petrella RJ, Aizawa K, Shoemaker K, Overend T, Piche L, Marin M, Shapiro S, Atkin S. Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial. Trials. 2011 Feb 16;12:45. doi: 10.1186/1745-6215-12-45.

  PMID: 21324150 BACKGROUND

• Stuckey M, Fulkerson R, Read E, Russell-Minda E, Munoz C, Kleinstiver P, Petrella R. Remote monitoring technologies for the prevention of metabolic syndrome: the Diabetes and Technology for Increased Activity (DaTA) study. J Diabetes Sci Technol. 2011 Jul 1;5(4):936-44. doi: 10.1177/193229681100500417.

  PMID: 21880237 BACKGROUND

• Stuckey M, Russell-Minda E, Read E, Munoz C, Shoemaker K, Kleinstiver P, Petrella R. Diabetes and Technology for Increased Activity (DaTA) study: results of a remote monitoring intervention for prevention of metabolic syndrome. J Diabetes Sci Technol. 2011 Jul 1;5(4):928-35. doi: 10.1177/193229681100500416.

  PMID: 21880236 BACKGROUND

• Noble E, Melling J, Shoemaker K, Tikkanen H, Peltonen J, Stuckey M, Petrella RJ. Innovation to reduce cardiovascular complications of diabetes at the intersection of discovery, prevention and knowledge exchange. Can J Diabetes. 2013 Oct;37(5):282-93. doi: 10.1016/j.jcjd.2013.07.061.

  PMID: 24500553 BACKGROUND

• Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement Sci. 2008 Jan 7;3:1. doi: 10.1186/1748-5908-3-1.

  PMID: 18179688 BACKGROUND

• Rycroft-Malone J, Harvey G, Kitson A, McCormack B, Seers K, Titchen A. Getting evidence into practice: ingredients for change. Nurs Stand. 2002 May 29-Jun 4;16(37):38-43. doi: 10.7748/ns2002.05.16.37.38.c3201.

  PMID: 12068568 BACKGROUND

• Ward V, House A, Hamer S. Knowledge Brokering: The missing link in the evidence to action chain? Evid Policy. 2009 Aug;5(3):267-279. doi: 10.1332/174426409X463811.

  PMID: 21258626 BACKGROUND

• Gill DP, Blunt W, Boa Sorte Silva NC, Stiller-Moldovan C, Zou GY, Petrella RJ. The HealtheSteps lifestyle prescription program to improve physical activity and modifiable risk factors for chronic disease: a pragmatic randomized controlled trial. BMC Public Health. 2019 Jun 28;19(1):841. doi: 10.1186/s12889-019-7141-2.

  PMID: 31253112 DERIVED

• Gill DP, Blunt W, Bartol C, Pulford RW, De Cruz A, Simmavong PK, Gavarkovs A, Newhouse I, Pearson E, Ostenfeldt B, Law B, Karvinen K, Moffit P, Jones G, Watson C, Zou G, Petrella RJ. HealtheSteps Study Protocol: a pragmatic randomized controlled trial promoting active living and healthy lifestyles in at-risk Canadian adults delivered in primary care and community-based clinics. BMC Public Health. 2017 Feb 7;17(1):173. doi: 10.1186/s12889-017-4047-8.

  PMID: 28173782 DERIVED

Related Links

• Improving the health of Canadians with evidence-based lifestyle prescriptions website

MeSH Terms

Conditions

Chronic Disease; Sedentary Behavior; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Robert J Petrella, MD, PhD

  University of Western Ontario, Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 9, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)