NCT00991380

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

3.3 years

First QC Date

October 7, 2009

Last Update Submit

July 9, 2013

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Physical Activity

    3 months

  • Physical Activity

    6 months

  • Physical Activity

    12 months

Study Arms (2)

Lifestyle counselling

EXPERIMENTAL
Behavioral: HEALD

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

HEALDBEHAVIORAL

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.

Also known as: Pedometer-based lifestyle intervention
Lifestyle counselling
Usual CareBEHAVIORAL

Control

Also known as: Control, Usual care, off group
Usual Care

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • physical limitation, cardiovascular contraindication, participation in any other research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alliance for Canadian Health Outcomes Research in Diabetes

Edmonton, Alberta, Canada

Location

Related Publications (3)

  • 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.

    PMID: 19614943BACKGROUND

  • 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.

    PMID: 26303892DERIVED

  • 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.

    PMID: 22712881DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jeffrey A Johnson, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Steven T Johnson, PhD

    University of Alberta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

CA(1)