Preventing Diabetes in Those at Risk by Having a Facilitator and Family Doctor Encourage Healthy Activity and Eating Habits (FLIP)
Primary Purpose
Prediabetes
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle changes
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetes
Eligibility Criteria
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
Sites / Locations
- UBC Family Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Lifestyle counseling
Usual care
Arm Description
Green prescription with facilitator support
Outcomes
Primary Outcome Measures
HbA1c Progression to diabetes
Secondary Outcome Measures
Full Information
NCT ID
NCT01589835
First Posted
April 30, 2012
Last Updated
March 4, 2014
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01589835
Brief Title
Preventing Diabetes in Those at Risk by Having a Facilitator and Family Doctor Encourage Healthy Activity and Eating Habits
Acronym
FLIP
Official Title
Preventing Diabetes With Facilitated Lifestyle Intervention Prescriptions.Phase 2: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Green prescription with facilitator support
Arm Title
Usual care
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle changes
Intervention Description
Green prescription with support from facilitator
Primary Outcome Measure Information:
Title
HbA1c Progression to diabetes
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Dawes
Organizational Affiliation
UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC Family Practice
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
12. IPD Sharing Statement
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Preventing Diabetes in Those at Risk by Having a Facilitator and Family Doctor Encourage Healthy Activity and Eating Habits
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