Healthy Eating & Active Living for Diabetes in Primary Care Networks (HEALD-PCN)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Jeffrey Johnson, The Alliance for Canadian Health Outcomes Research in Diabetes
ClinicalTrials.gov Identifier:
NCT00991380
First received: October 7, 2009
Last updated: July 9, 2013
Last verified: July 2013
  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 ]

Enrollment: 200
Study Start Date: October 2009
Study Completion Date: January 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Dr. Jeffrey Johnson, Professor and Chair, 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: July 9, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 28, 2014