NCT01589835

Brief Summary

Nearly six million Canadians are living with an increased risk of diabetes (prediabetes) and approximately 50% of these will develop type 2 diabetes within five years. The investigators wish to help these people change their lifestyle, to prevent them from getting diabetes. Trials have shown that by supporting people with prediabetes to be more active and have healthier eating habits they can halve their risk. However, these interventions were very costly and not performed in Canada. With the help of local Family Physicians and other health professionals (e.g. physiotherapy, psychology, endocrinology, nursing) the investigators have created a less expensive intervention suitable for the Canadian population and health system. The investigators need to perform a study to see whether these modified approaches are practical for Canadians and likely to be effective. People at risk will be invited to participate from family practices that have helped us in the initial stages of this program. Family practices will be randomized to giving either the study intervention or continue with the physician's usual care. People receiving the intervention will have an appointment with their family doctor to discuss their exercise and eating habits and agree changes that are necessary. A prescription detailing these changes will be completed and signed by the family physician and participant. Participants will be given the name of a lifestyle change facilitator (LCF) who will receive a copy of the prescription and contact the participant to help them set achievable goals. The LCF will contact participants once a month for six months to help them achieve these goals. The investigators eventual aim is to test this intervention in a large-scale randomized control trial. To achieve this it is necessary to pilot all aspects of the trial. Information from the pilot study can then be used to design and perform a large-scale study effectively. The investigators hope that eventually the numbers of Canadians progressing to having diabetes will be reduced.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

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

First Submitted

Initial submission to the registry

April 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

April 30, 2012

Last Update Submit

March 4, 2014

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c Progression to diabetes

    6 months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Green prescription with facilitator support

Behavioral: Lifestyle changes

Usual care

OTHER
Behavioral: Lifestyle changes

Interventions

Lifestyle changesBEHAVIORAL

Green prescription with support from facilitator

Lifestyle counselingUsual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥ 18 years
  • HbA1c of 5.7 to 6.4% and/or FPG of 6.1 to 6.9 mmol/l and/or a 2hr 75g OGTT of between 7.8 and 11.0 mmol/l

You may not qualify if:

  • People with Type I or II diabetes
  • Unstable angina
  • Uncontrolled congestive heart failure
  • Unstable arrhythmia
  • Heart valvular disease
  • Severe hypertension (systolic ≥ 200 or diastolic ≥ 120)
  • Pregnant women or planning pregnancy within two years
  • Life expectancy \< 1 year
  • Waiting for major surgery
  • High risk of fracture
  • Pregnancy or planning pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Family Practice

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Martin Dawes

    UBC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

July 1, 2012

Primary Completion

October 1, 2013

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

CA(1)