Type 2 DiabetesPhase 3NCT02036892
Electronically Connected Health Coaching in Type 2 Diabetes
A Phase 3 study testing Lifestyle counseling with smartphone and Lifestyle counseling in people with Type 2 Diabetes, run by York University at 1 site in Canada.
Trial summary
Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lifestyle counseling with smartphone and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jun 2014
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 2 Diabetes
- Fluency in English and/or Spanish
Who cannot join
- > 75 years of age
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Black Creek Community Health Centre
Toronto, Ontario, M3M1A4
Paul Ritvo, PhD, 4165808021, pritvo@yorku.ca
Noah Wayne, MSc, 4168897289, NoahWayne@gmail.com
About this study
Official title: Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial
Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).
Read the detailed description
Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels > or = to 7.3.
Exclusion criteria: Axis I and II psychiatric disorders.
Primary outcome: HBA1c at 6 months follow up.
Secondary outcome: Centre for Epidemiological Studies Depression Scale
- Conditions
- Type 2 Diabetes
- Being tested
- Lifestyle counseling with smartphone, Lifestyle counseling
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counseling with smartphoneBehavioural
Lifestyle counseling with health promoting smartphone software
Lifestyle counselingBehavioural
Lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling with smartphones | Experimental | Lifestyle counseling assisted by smartphones Receives: Behavioral: Lifestyle counseling with smartphone |
| Lifestyle counseling | Active comparator | Lifestyle counseling Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Finger prick A1c test or lab test
Measured: 6 months follow up from baseline
Secondary outcomes (1)
Center for Epidemiological Studies Depression Scale
Self report measure of psychological distress
Measured: 6 months follow up from baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startFeb 2012
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Paul Ritvo, York University
- Investigators
- Paul Ritvo, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036892
- Sponsor's protocol ID
- 13-001
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wayne N, Perez DF, Kaplan DM, Ritvo P. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. J Med Internet Res. 2015 Oct 5;17(10):e224. doi: 10.2196/jmir.4871.
PubMed 26441467Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: A qualitative inquiry. J Telemed Telecare. 2016 Apr;22(3):172-8. doi: 10.1177/1357633X15595178. Epub 2015 Jul 21.
PubMed 26199275
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial
- ClinicalTrials.gov ID
- NCT02036892
- Acronym / sponsor ID
- 13-001
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- Feb 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 15 Jan 2014 (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.
Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).
Detailed description
Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels > or = to 7.3.
Exclusion criteria: Axis I and II psychiatric disorders.
Primary outcome: HBA1c at 6 months follow up.
Secondary outcome: Centre for Epidemiological Studies Depression Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling with smartphones | Experimental | Behavioral: Lifestyle counseling with smartphoneLifestyle counseling assisted by smartphones |
| Lifestyle counseling | Active comparator | Behavioral: Lifestyle counselingLifestyle counseling |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 Diabetes
- Fluency in English and/or Spanish
Key exclusion criteria (1 listed)
- > 75 years of age
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 |
|---|---|---|
| Lifestyle counseling with smartphoneLifestyle counseling with health promoting smartphone software | Behavioural | Lifestyle counseling with smartphones |
| Lifestyle counselingLifestyle counseling | Behavioural | Lifestyle counseling |
Primary outcome
Hemoglobin A1c
Time frame: 6 months follow up from baseline
Finger prick A1c test or lab test
1 secondary outcome
Center for Epidemiological Studies Depression Scale
Time frame: 6 months follow up from baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Derived from this study: PubMed 26441467Wayne N, Perez DF, Kaplan DM, Ritvo P. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. J Med Internet Res. 2015 Oct 5;17(10):e224. doi: 10.2196/jmir.4871.
- Derived from this study: PubMed 26199275Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: A qualitative inquiry. J Telemed Telecare. 2016 Apr;22(3):172-8. doi: 10.1177/1357633X15595178. Epub 2015 Jul 21.
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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.
Paul Ritvo, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lifestyle counseling with smartphone and Lifestyle counseling in people with Type 2 Diabetes, run by York University at 1 site 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Ritvo, PhD (4165808021, pritvo@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 6 months follow up from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02036892, which also lists 2 linked publications.
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 15 Jan 2014.