Type 2 DiabetesHEALD-PCNNCT00991380
Healthy Eating & Active Living for Diabetes in Primary Care Networks
A study testing HEALD in people with Type 2 Diabetes, run by The Alliance for Canadian Health Outcomes Research in Diabetes at 1 site in Canada.
Trial summary
The investigators aim to establish the effectiveness of a prescribed, community-based lifestyle modification program for those with recently diagnosed diabetes. The investigators hypothesize that those who enter a 6 month program will report greater levels of physical activity compared to a group who do not enter the… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HEALD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Jan 2013
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult, recent type 2 diabetes diagnosis according to a diabetes patient registry, received a referral to a group-based lifestyle program or some provider-based diabetes related education.
Who cannot join
- physical limitation, cardiovascular contraindication, participation in any other research study
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Alliance for Canadian Health Outcomes Research in Diabetes
Edmonton, Alberta
About this study
The investigators aim to establish the effectiveness of a prescribed, community-based lifestyle modification program for those with recently diagnosed diabetes. The investigators hypothesize that those who enter a 6 month program will report greater levels of physical activity compared to a group who do not enter the program but who continue to receive usual care.
- Conditions
- Type 2 Diabetes
- Being tested
- HEALD, Usual Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALDBehavioural
Also called Pedometer-based lifestyle intervention
A six month, two phase pedometer-based walking program. For weeks one and two of phase I, participants will attend a group-based 60 minute education/supervised walking session. They will be asked to set a daily step goal and to attempt to achieve this on a daily basis over three months. Their steps will be recorded in a step log. For weeks one and two of phase II, participants will learn how to increase the speed of a portion of their daily steps and will learn the concept of low glycemic index and how to set dietary goals related to this concept. They will attend two sixty minute group-based education/supervised walking sessions.
Usual CareBehavioural
Also called Control, Usual care, off group
Control
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counselling | Experimental | Not described Receives: Behavioral: HEALD |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Measured: 3 months
Physical Activity
Measured: 6 months
Physical Activity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alliance for Canadian Health Outcomes Research in Diabetes
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Jeffrey Johnson, The Alliance for Canadian Health Outcomes Research in Diabetes
- Investigators
- Jeffrey A Johnson, PhD, Principal investigator, University of AlbertaSteven T Johnson, PhD, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991380
- Sponsor's protocol ID
- Ach0rd-1001-09
- Acronym
- HEALD-PCN
- Status last verified
- Jul 2013
- First submitted
- 7 Oct 2009
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson ST, Bell GJ, McCargar LJ, Welsh RS, Bell RC. Improved cardiovascular health following a progressive walking and dietary intervention for type 2 diabetes. Diabetes Obes Metab. 2009 Sep;11(9):836-43. doi: 10.1111/j.1463-1326.2009.01050.x. Epub 2009 Jul 10.
PubMed 19614943Mathe N, Johnson ST, Wozniak LA, Majumdar SR, Johnson JA. Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design. Trials. 2015 Aug 25;16:375. doi: 10.1186/s13063-015-0904-x.
PubMed 26303892Johnson ST, Mundt C, Soprovich A, Wozniak L, Plotnikoff RC, Johnson JA. Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes. BMC Public Health. 2012 Jun 19;12:455. doi: 10.1186/1471-2458-12-455.
PubMed 22712881
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating & Active Living for Diabetes in Primary Care Networks
- ClinicalTrials.gov ID
- NCT00991380
- Acronym / sponsor ID
- HEALD-PCN / Ach0rd-1001-09
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Alliance for Canadian Health Outcomes Research in DiabetesUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Oct 2009 (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.
The investigators aim to establish the effectiveness of a prescribed, community-based lifestyle modification program for those with recently diagnosed diabetes. The investigators hypothesize that those who enter a 6 month program will report greater levels of physical activity compared to a group who do not enter the program but who continue to receive usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counselling | Experimental | Behavioral: HEALD |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult, recent type 2 diabetes diagnosis according to a diabetes patient registry, received a referral to a group-based lifestyle program or some provider-based diabetes related education.
Key exclusion criteria (1 listed)
- physical limitation, cardiovascular contraindication, participation in any other research study
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 |
|---|---|---|
| HEALDAlso: Pedometer-based lifestyle interventionA six month, two phase pedometer-based walking program. For weeks one and two of phase I, participants will attend a group-based 60 minute education/supervised walking session. They will be asked to set a daily step goal and to attempt to achieve this on a daily basis over three months. Their steps will be recorded in a step log. For weeks one and two of phase II, participants will learn how to increase the speed of a portion of their daily steps and will learn the concept of low glycemic index and how to set dietary goals related to this concept. They will attend two sixty minute group-based education/supervised walking sessions. | Behavioural | Lifestyle counselling |
| Usual CareAlso: Control, Usual care, off groupControl | Behavioural | Usual Care |
Primary outcome
Physical Activity
Time frame: 3 months
Physical Activity
Time frame: 6 months
Physical Activity
Time frame: 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 11 Jul 2013.
- Background: PubMed 19614943Johnson ST, Bell GJ, McCargar LJ, Welsh RS, Bell RC. Improved cardiovascular health following a progressive walking and dietary intervention for type 2 diabetes. Diabetes Obes Metab. 2009 Sep;11(9):836-43. doi: 10.1111/j.1463-1326.2009.01050.x. Epub 2009 Jul 10.
- Derived from this study: PubMed 26303892Mathe N, Johnson ST, Wozniak LA, Majumdar SR, Johnson JA. Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design. Trials. 2015 Aug 25;16:375. doi: 10.1186/s13063-015-0904-x.
- Derived from this study: PubMed 22712881Johnson ST, Mundt C, Soprovich A, Wozniak L, Plotnikoff RC, Johnson JA. Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes. BMC Public Health. 2012 Jun 19;12:455. doi: 10.1186/1471-2458-12-455.
- Click here for more details about the Alliance for Canadian Health Outcomes Research in DiabetesLink provided by the sponsor.
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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.
Jeffrey A Johnson, PhD principal investigator
University of Alberta
Steven T Johnson, PhD study director
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEALD in people with Type 2 Diabetes, run by The Alliance for Canadian Health Outcomes Research in Diabetes 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 1 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: finished, as of the sponsor's last update on 11 Jul 2013. 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.
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?
Physical Activity (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT00991380, which also lists 3 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 11 Jul 2013.