Evidence-Based Lifestyle Prescription Program: Pilot Study

Overweight Clinical Trial

— HeSP  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413385
• Other study ID #: HealtheSteps3
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: September 27, 2017
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: September 2017
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Overweight
• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
Canada	SJHC Family Medical Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Public Health Agency of Canada (PHAC)

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Eating habits: Total healthful eating score	Measured by Starting the conversation questionnaire	6 months (plus 12 and 18 months in the intervention group only)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Resting systolic blood pressure	Measured using automated blood pressure monitor	6 months (plus 12 and 18 months in the intervention group only)
Secondary	Resting diastolic blood pressure	Measured using automated blood pressure monitor	6 months (plus 12 and 18 months in the intervention group only)
Secondary	Weight loss (absolute and percentage)	Measured using digital weight scale	6 months (plus 12 and 18 months in the intervention group only)
Secondary	Waist circumference	Measured using tape measure	6 months (plus 12 and 18 months in the intervention group only)
Secondary	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)

External Links

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