Healthy Eating & Active Living for Diabetes in Primary Care Networks

NCT ID: NCT00991380

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lifestyle counselling

Group Type EXPERIMENTAL

HEALD

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Usual Care

Control

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pedometer-based lifestyle intervention Control, Usual care, off group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

The Alliance for Canadian Health Outcomes Research in Diabetes

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Jeffrey Johnson

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey A Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Steven T Johnson, PhD

Role: STUDY_DIRECTOR

University of Alberta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Alliance for Canadian Health Outcomes Research in Diabetes

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19614943 (View on PubMed)

Mathe 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.

Reference Type DERIVED
PMID: 26303892 (View on PubMed)

Johnson 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.

Reference Type DERIVED
PMID: 22712881 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.achord.ca

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ach0rd-1001-09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention and Choice for Type 2
NCT06377020 COMPLETED NA
Small Steps for Big Changes - Recipe for Health
NCT05962983 NOT_YET_RECRUITING NA