Health Coaching to Effect Lifestyle Behaviour Change

Study Overview
=================
Brief Summary
-----------------
A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes) but without pre-existing cardiovascular disease will effectively help participants change their lifestyle behaviour and prevent or delay onset of cardiovascular disease.

Official Title
-----------------
Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease

Conditions
-----------------
Prediabetes, Prehypertension

Intervention / Treatment
-----------------
* Behavioral: Health Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-60 years Last recorded fasting blood glucose between 6.0 abd 6.9 mmol/L Last recorded blood pressure between 130-139 mmHG systolic and/or85-89 mmHG diastolic Exclusion Criteria: Diagnosis of diabetes on the chart Diagnosis of hypertension on the chart taking an anti-diabetic medication taking an antihypertensive medication

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Coaching<br> | Behavioral: Health Coaching<br>* The intervention will take approximately six months to complete. A combination of group and individual face-to-face meetings will be used. Participants will be divided into groups of 20 for group meetings. Groups will be brought together for a group coaching session at the beginning and the end of the coaching process (i.e., intervention). Each participant will also receive four individual coaching sessions with the health coach and will be able to avail of three one-hour telephone coaching sessions during the six month intervention. Participants will be encouraged to utilize telephone coaching for key support periods.<br>|
| No Intervention: Usual Care -Control<br>Patients assigned to the control (usual care) group will be advised to seek standard lifestyle counselling from their primary care physician. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire |  | baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Self-efficacy |  | baseline, 6 months, 12 months | 
| Change from baseline in score on the Framingham-based Global Risk Assessment |  | baseline, 6 months, 12 months | 
| Change from baseline in blood pressure as measured by the BpTRU device |  | baseline, 6 months, 12 months | 
| Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser |  | baseline, 6 months, 12 months | 
| Change from baseline in health related quality of life |  | baseline, 6 months, 12 months |