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Lifestyle Change Program for Prediabetes (PREPARE Trial)
N/A
Waitlist Available
Led By Isabelle T. Giroux, PhD
Research Sponsored by Brescia University College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be able to understand English enough to participate in the educational discussions and activities and to fill in required questionnaires
Adults; 30 years of age or older, residing in the London (Ontario, Canada) or surrounding area (including Middlesex), who currently have prediabetes diagnosed by their health care provider and who have been referred to the Diabetes Education Centre of St. Joseph's Health Care London by a physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 12 months after the baseline assessment
Awards & highlights
PREPARE Trial Summary
This trial will see if a 6-month program to change lifestyle habits can help middle-aged and older adults with prediabetes.
Who is the study for?
The PREPARE trial is for adults aged 30 or older living near London, Ontario with prediabetes referred by a physician. Participants must be able to engage in low-impact exercise, eat a balanced diet, and understand English. Those with diabetes, other health conditions preventing full participation, pregnancy, or involvement in similar programs cannot join.Check my eligibility
What is being tested?
This study tests the PREPARE education program against standard care for people with prediabetes. It aims to see if this community-based intervention can lead to healthier lifestyle choices over six months compared to usual advice given by healthcare providers.See study design
What are the potential side effects?
Since the interventions involve education and lifestyle changes rather than medication, side effects are not typical as seen with drugs but may include muscle soreness from new physical activities or dietary adjustments.
PREPARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and communicate in English well enough for discussions and questionnaires.
Select...
I am 30 or older, live near London, Ontario, have prediabetes, and was referred to St. Joseph's Diabetes Centre.
Select...
I do not have diabetes or any condition that would stop me from fully participating.
PREPARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months and 12 months after the baseline assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 12 months after the baseline assessment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average number of vegetable and fruit servings consumed per day
Secondary outcome measures
average number of physical activity minutes per day
PREPARE Trial Design
2Treatment groups
Experimental Treatment
Group I: PREPARE education programExperimental Treatment1 Intervention
This is a 6-month program that consists of monthly nutrition and physical activity education sessions (2 hours per session) and includes interactive hands-on activities to help you gain knowledge and skills to make positive lifestyle choices. It is a pilot study to test the effectiveness of this type of health-care program in individuals with prediabetes.
Group II: Control armExperimental Treatment1 Intervention
Individuals self-selecting the control arm receive the current standard of care for prediabetes, which is a one-time 2-hour group education session. In addition, the individuals are asked to provide some information at baseline and 6 months and 1 year later. The information collected will include a record of dietary and physical activity habits and whether or not they have developed Type 2 diabetes.
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Who is running the clinical trial?
Brescia University CollegeLead Sponsor
Isabelle T. Giroux, PhDPrincipal InvestigatorBrescia University College
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been diagnosed with prediabetes nor referred to St. Joseph's Diabetes Education Centre.You are not living in or around London, Ontario, Canada.You are currently involved in another program that helps you change your habits or lifestyle.I can understand and communicate in English well enough for discussions and questionnaires.I cannot chew or digest food normally.I am 30 or older, live near London, Ontario, have prediabetes, and was referred to St. Joseph's Diabetes Centre.I cannot do low impact activities due to being chair-bound or having low mobility.You should be able to do gentle physical activities.I have diabetes or a condition that might limit my participation in the program.I am under 30 years old.You should be able to eat a variety of different foods.I do not have diabetes or any condition that would stop me from fully participating.
Research Study Groups:
This trial has the following groups:- Group 1: PREPARE education program
- Group 2: Control arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there openings available for participants in this study?
"Per clinicaltrials.gov, this specific trial is no longer seeking participants, having initially been posted on May 1st 2011 and last updated July 18th of the same year. Fortunately, there are 222 other studies currently recruiting for volunteers."
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