Health Coaching to Effect Lifestyle Behaviour Change

Prediabetes Clinical Trial

— HC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458496
• Other study ID #: 243401
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: March 14, 2016
• Start date: October 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prediabetes
• Prehypertension

Intervention

Behavioral:
• Health Coaching
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.

Locations

Country	Name	City	State
Canada	Memorial University of Newfoundland	St. John's	Newfoundland and Labrador
Canada	Memorial University of Newfoundland	St. John's	Newfoundland and Labrador

Sponsors (2)

Lead Sponsor	Collaborator
Marshal Godwin	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire		baseline, 6 months, 12 months	No
Secondary	Change from baseline in Self-efficacy		baseline, 6 months, 12 months	No
Secondary	Change from baseline in score on the Framingham-based Global Risk Assessment		baseline, 6 months, 12 months	No
Secondary	Change from baseline in blood pressure as measured by the BpTRU device		baseline, 6 months, 12 months	No
Secondary	Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser		baseline, 6 months, 12 months	No
Secondary	Change from baseline in health related quality of life		baseline, 6 months, 12 months	No