PrediabetesHCNCT01458496
Health Coaching to Effect Lifestyle Behaviour Change
A study testing Health Coaching in people with Prediabetes and Prehypertension, run by Marshal Godwin at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Prehypertension
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of diabetes on the chart
- Diagnosis of hypertension on the chart
- taking an anti-diabetic medication
- taking an antihypertensive medication
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B 3V6
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1N 3V6
About this study
Official title: Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease
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
- Being tested
- Health Coaching
- Medical subject headings
- Prediabetic State, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire
Measured: baseline, 6 months, 12 months
Secondary outcomes (5)
Change from baseline in Self-efficacy
Measured: baseline, 6 months, 12 months
Change from baseline in score on the Framingham-based Global Risk Assessment
Measured: baseline, 6 months, 12 months
Change from baseline in blood pressure as measured by the BpTRU device
Measured: baseline, 6 months, 12 months
Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser
Measured: baseline, 6 months, 12 months
Change from baseline in health related quality of life
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshal Godwin
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Marshal Godwin, Memorial University of Newfoundland
- Investigators
- Marshall Godwin, MD, MSc, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458496
- Sponsor's protocol ID
- 243401
- Acronym
- HC
- Status last verified
- Mar 2016
- First submitted
- 18 Oct 2011
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease
- ClinicalTrials.gov ID
- NCT01458496
- Acronym / sponsor ID
- HC / 243401
- Conditions
- Prediabetes, Prehypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Marshal GodwinUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosis of diabetes on the chart
- Diagnosis of hypertension on the chart
- taking an anti-diabetic medication
- taking an antihypertensive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health CoachingThe 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. | Behavioural | Health Coaching |
Primary outcome
Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire
Time frame: baseline, 6 months, 12 months
5 secondary outcomes
Change from baseline in Self-efficacy
Time frame: baseline, 6 months, 12 months
Change from baseline in score on the Framingham-based Global Risk Assessment
Time frame: baseline, 6 months, 12 months
Change from baseline in blood pressure as measured by the BpTRU device
Time frame: baseline, 6 months, 12 months
Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser
Time frame: baseline, 6 months, 12 months
Change from baseline in health related quality of life
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshall Godwin, MD, MSc principal investigator
Memorial University of Newfoundland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Prediabetes and Prehypertension, run by Marshal Godwin at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.