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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

Must not have

Adults who do not currently have a diagnosis of prediabetes and have not been referred to the Diabetes Education Centre of St. Joseph's Health Care London by a physician

Being unable to chew and digest food normally and to eat a balanced diet

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months and 12 months after the baseline assessment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and communicate in English well enough for discussions and questionnaires.

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I am 30 or older, live near London, Ontario, have prediabetes, and was referred to St. Joseph's Diabetes Centre.

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I do not have diabetes or any condition that would stop me from fully participating.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been diagnosed with prediabetes nor referred to St. Joseph's Diabetes Education Centre.

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I cannot chew or digest food normally.

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I cannot do low impact activities due to being chair-bound or having low mobility.

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I have diabetes or a condition that might limit my participation in the program.

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I am under 30 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months and 12 months after the baseline assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average number of vegetable and fruit servings consumed per day

Secondary study objectives

average number of physical activity minutes per day

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met