Health Coaching to Effect Lifestyle Behaviour Change

NCT01458496 | Completed DMC

• 1 other identifier: 243401
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 2

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.

Conditions

Prediabetes; Prehypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire

  baseline, 6 months, 12 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Health Coaching

EXPERIMENTAL

Behavioral: Health Coaching

Usual Care -Control

NO INTERVENTION

Patients assigned to the control (usual care) group will be advised to seek standard lifestyle counselling from their primary care physician.

Interventions

Health Coaching BEHAVIORAL

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.

Health Coaching

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of diabetes on the chart
• Diagnosis of hypertension on the chart
• taking an anti-diabetic medication
• taking an antihypertensive medication

Sponsors & Collaborators

• Marshal Godwin: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1N 3V6, Canada

Location

MeSH Terms

Conditions

Prediabetic State; Prehypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marshall Godwin, MD, MSc

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Faculty of Medicine

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

CA (2)