PREPARE: "Prediabetes Research and Education Promoting Activity & Responsible Eating" (PREPARE)
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|ClinicalTrials.gov Identifier: NCT01396772|
Recruitment Status : Unknown
Verified July 2011 by Brescia University College.
Recruitment status was: Recruiting
First Posted : July 19, 2011
Last Update Posted : July 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes||Behavioral: PREPARE education program Other: standard of care presentation||Not Applicable|
This community-based, healthy lifestyle project targets middle (30-59) and older (60+) adults with prediabetes - a population known to be at high risk for Type 2 diabetes development.
This project aims to create, deliver and evaluate a six month interdisciplinary education and lifestyle improvement intervention that emphasizes goal-setting and self-management approaches to inform, engage, monitor and support adults with prediabetes in making positive lifestyle changes within the London (Ontario, Canada) community.
Participants are encouraged to reflect on their current lifestyle, resources and barriers, increase skills, motivation, and awareness of community resources, and make positive lifestyle changes. Based on a solid partnership between both community - health service providers and Brescia University College, the Prediabetes Initiative aims at empowering individuals with prediabetes through self-management approaches to reduce behaviours known to contribute to Type 2 diabetes development.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Community-based Healthy Lifestyle Patient-centred Education Program for Middle & Older Adults With Prediabetes, Which Strengthens the Delivery of Health Services and Assists Individuals at High-risk for Diabetes in London, Ontario.|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||June 2013|
Experimental: PREPARE education program
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.
Behavioral: PREPARE education program
PREPARE stands for "Prediabetes Research and Education Promoting Activity and Responsible Eating" and is a 6-month community-based prediabetes lifestyle and behaviour change intervention program. It includes a series of six interactive education sessions of two hours each on healthy eating and physical activity.
Other Name: Prediabetes Research and Education Program
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.
Other: standard of care presentation
A one-time 2-hour group prediabetes education session, offered as the standard for individuals referred for prediabetes in London, Ontario (Canada)
Other Name: Standard
- Average number of vegetable and fruit servings consumed per day [ Time Frame: Baseline, 6 months and 12 months after the baseline assessment ]Data collected using a standard 3-Day Food Intake Record and Medication Log form at the three time points.
- average number of physical activity minutes per day [ Time Frame: Baseline, 6 months and 12 months after the baseline assessment ]Data collected using a 7-Day Physical Activity and Step Log standard form.
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 ClinicalTrials.gov identifier (NCT number): NCT01396772
|Contact: Isabelle T. Giroux, PhD||519-432-8353 ext firstname.lastname@example.org|
|Brescia University College||Recruiting|
|London, Ontario, Canada, N6G1H2|
|Contact: Isabelle T. Giroux, PhD 519-432-8353 ext 28255 email@example.com|
|Contact: Gillian Mandich, BhSc 519-432-8353 ext 28034 firstname.lastname@example.org|
|Principal Investigator: Isabelle T. Giroux, PhD, RD|
|Principal Investigator:||Isabelle T. Giroux, PhD||Brescia University College|