Healthy Eating & Active Living for Diabetes in Primary Care Networks (HEALD-PCN)
This study is enrolling participants by invitation only.
Sponsor:
The Alliance for Canadian Health Outcomes Research in Diabetes
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
The Alliance for Canadian Health Outcomes Research in Diabetes
ClinicalTrials.gov Identifier:
NCT00991380
First received: October 7, 2009
Last updated: January 13, 2010
Last verified: October 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Behavioral: HEALD Behavioral: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Healthy Eating & Active Living for Diabetes in Primary Care Networks |
Resource links provided by NLM:
Further study details as provided by The Alliance for Canadian Health Outcomes Research in Diabetes:
Primary Outcome Measures:
- Physical Activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Physical Activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lifestyle counselling |
Behavioral: HEALD
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.
Other Name: Pedometer-based lifestyle intervention
|
| Active Comparator: Usual Care |
Behavioral: Usual Care
Control
Other Name: Control, Usual care, off group
|
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- physical limitation, cardiovascular contraindication, participation in any other research study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991380
Locations
| Canada, Alberta | |
| The Alliance for Canadian Health Outcomes Research in Diabetes | |
| Edmonton, Alberta, Canada | |
Sponsors and Collaborators
The Alliance for Canadian Health Outcomes Research in Diabetes
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Jeffrey A Johnson, PhD | University of Alberta |
| Study Director: | Steven T Johnson, PhD | University of Alberta |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeffrey Johnson, PhD, The Alliance for Canadian Health Outcomes Research in Diabetes |
| ClinicalTrials.gov Identifier: | NCT00991380 History of Changes |
| Other Study ID Numbers: | Ach0rd-1001-09 |
| Study First Received: | October 7, 2009 |
| Last Updated: | January 13, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013