Preventing Diabetes in Those at Risk by Having a Facilitator and Family Doctor Encourage Healthy Activity and Eating Habits (FLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01589835
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : March 5, 2014
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Prediabetes Behavioral: Lifestyle changes Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Diabetes With Facilitated Lifestyle Intervention Prescriptions.Phase 2: Pilot Study
Study Start Date : July 2012
Actual Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle counseling
Green prescription with facilitator support
Behavioral: Lifestyle changes
Green prescription with support from facilitator
Usual care Behavioral: Lifestyle changes
Green prescription with support from facilitator

Primary Outcome Measures :
  1. HbA1c Progression to diabetes [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01589835

Canada, British Columbia
UBC Family Practice
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Martin Dawes UBC

Responsible Party: University of British Columbia Identifier: NCT01589835     History of Changes
Other Study ID Numbers: H12-01330
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases