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OpenTrials
Completed

NCT Number: NCT01458496

Health Coaching to Effect Lifestyle Behaviour Change

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.

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Key information

Conditions

PreDiabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State Prehypertension Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: baseline, 6 months, 12 months

Secondary outcomes

  1. Change from baseline in Self-efficacy

    Time frame: baseline, 6 months, 12 months

  2. Change from baseline in score on the Framingham-based Global Risk Assessment

    Time frame: baseline, 6 months, 12 months

  3. Change from baseline in blood pressure as measured by the BpTRU device

    Time frame: baseline, 6 months, 12 months

  4. Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser

    Time frame: baseline, 6 months, 12 months

  5. Change from baseline in health related quality of life

    Time frame: baseline, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Marshal Godwin

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: HC

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2011
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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