Healthy Eating & Active Living for Diabetes in Primary Care Networks

Type 2 Diabetes Clinical Trial

— HEALD-PCN  

Official title:

Healthy Eating & Active Living for Diabetes in Primary Care Networks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991380
• Other study ID #: Ach0rd-1001-09
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: July 9, 2013
• Start date: October 2009
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: The Alliance for Canadian Health Outcomes Research in Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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 program but who continue to receive usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.
• Usual Care
Control

Locations

Country	Name	City	State
Canada	The Alliance for Canadian Health Outcomes Research in Diabetes	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
The Alliance for Canadian Health Outcomes Research in Diabetes	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Erratum in: Diabetes Obes Metab. 2012 Apr;14(4):385. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity		3 months	No
Primary	Physical Activity		6 months	No
Primary	Physical Activity		12 months	No

External Links

•   Click here for more details about the Alliance for Canadian Health Outcomes Research in Diabetes