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

Preventing Diabetes With Facilitated Lifestyle Intervention Prescriptions.Phase 2: Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Behavioral: Lifestyle changes

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • UBC Family Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care	Behavioral: Lifestyle changes; Green prescription with support from facilitator
Experimental: Lifestyle counseling; Green prescription with facilitator support	Behavioral: Lifestyle changes; Green prescription with support from facilitator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c Progression to diabetes	6 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Martin Dawes, UBC

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: H12-01330