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PREPARE: "Prediabetes Research and Education Promoting Activity & Responsible Eating" (PREPARE)

Primary Purpose

Prediabetes

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PREPARE education program
standard of care presentation
Sponsored by
Brescia University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring prediabetes, diabetes prevention, adults, lifestyle intervention, Social Cognitive Theory, dietary intake, physical activity

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 (e.g. family physician) and who have been referred to the Diabetes Education Centre of St. Joseph's Health Care London by a physician.
  • Eligible participants must not be currently participating in another lifestyle or behaviour change education or research program; must be able to perform low impact physical activity; must be able to eat a balanced diet; must not be lactating or pregnant; and must be able to understand English enough to participate in the educational discussions and activities and to fill in required questionnaires.
  • Eligible participants must not be diagnosed with Type 1 or Type 2 diabetes, or any condition (e.g. cancer, etc) or behavioural or psychiatric issues (such as a diagnosis of major depression, eating disorder, schizophrenia or other mental illness) as this will prevent full engagement in the program.

Exclusion Criteria:

  • Non-adults; adults of less than 30 years of age; adults residing outside the London (Ontario, Canada) and surrounding area; 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
  • Individuals currently participating in another lifestyle or behaviour change education or research program.
  • Not being able to perform low impact physical activity, such as being chair-bound or having low mobility;
  • Being unable to chew and digest food normally and to eat a balanced diet (e.g. being on a specialized diet such as a low-fiber diet or enteral nutrition support due to a pre-existing condition, such as Crohn's disease, celiac disease or other digestive disease);
  • Currently lactating or being pregnant;
  • Being unable to understand, read and write the English language; or
  • Having a diagnosis of Type 1 or Type 2 diabetes, or any condition (e.g. cancer, etc) or behavioural or psychiatric issues (such as a diagnosis of major depression, anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified [EDNOS], schizophrenia or other mental illness) that would prevent full engagement in the program.

Sites / Locations

  • Brescia University CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PREPARE education program

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Average number of vegetable and fruit servings consumed per day
Data collected using a standard 3-Day Food Intake Record and Medication Log form at the three time points.

Secondary Outcome Measures

average number of physical activity minutes per day
Data collected using a 7-Day Physical Activity and Step Log standard form.

Full Information

First Posted
July 18, 2011
Last Updated
July 18, 2011
Sponsor
Brescia University College
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1. Study Identification

Unique Protocol Identification Number
NCT01396772
Brief Title
PREPARE: "Prediabetes Research and Education Promoting Activity & Responsible Eating"
Acronym
PREPARE
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Brescia University College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if a 6-month community-based prediabetes lifestyle and behaviour change intervention (called, PREPARE) for middle and older adults with prediabetes will result in positive lifestyle behaviour change.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
prediabetes, diabetes prevention, adults, lifestyle intervention, Social Cognitive Theory, dietary intake, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PREPARE education program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PREPARE education program
Other Intervention Name(s)
Prediabetes Research and Education Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard of care presentation
Other Intervention Name(s)
Standard
Intervention Description
A one-time 2-hour group prediabetes education session, offered as the standard for individuals referred for prediabetes in London, Ontario (Canada)
Primary Outcome Measure Information:
Title
Average number of vegetable and fruit servings consumed per day
Description
Data collected using a standard 3-Day Food Intake Record and Medication Log form at the three time points.
Time Frame
Baseline, 6 months and 12 months after the baseline assessment
Secondary Outcome Measure Information:
Title
average number of physical activity minutes per day
Description
Data collected using a 7-Day Physical Activity and Step Log standard form.
Time Frame
Baseline, 6 months and 12 months after the baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 (e.g. family physician) and who have been referred to the Diabetes Education Centre of St. Joseph's Health Care London by a physician. Eligible participants must not be currently participating in another lifestyle or behaviour change education or research program; must be able to perform low impact physical activity; must be able to eat a balanced diet; must not be lactating or pregnant; and must be able to understand English enough to participate in the educational discussions and activities and to fill in required questionnaires. Eligible participants must not be diagnosed with Type 1 or Type 2 diabetes, or any condition (e.g. cancer, etc) or behavioural or psychiatric issues (such as a diagnosis of major depression, eating disorder, schizophrenia or other mental illness) as this will prevent full engagement in the program. Exclusion Criteria: Non-adults; adults of less than 30 years of age; adults residing outside the London (Ontario, Canada) and surrounding area; 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 Individuals currently participating in another lifestyle or behaviour change education or research program. Not being able to perform low impact physical activity, such as being chair-bound or having low mobility; Being unable to chew and digest food normally and to eat a balanced diet (e.g. being on a specialized diet such as a low-fiber diet or enteral nutrition support due to a pre-existing condition, such as Crohn's disease, celiac disease or other digestive disease); Currently lactating or being pregnant; Being unable to understand, read and write the English language; or Having a diagnosis of Type 1 or Type 2 diabetes, or any condition (e.g. cancer, etc) or behavioural or psychiatric issues (such as a diagnosis of major depression, anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified [EDNOS], schizophrenia or other mental illness) that would prevent full engagement in the program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle T. Giroux, PhD
Phone
519-432-8353
Ext
28255
Email
igiroux@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle T. Giroux, PhD
Organizational Affiliation
Brescia University College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brescia University College
City
London
State/Province
Ontario
ZIP/Postal Code
N6G1H2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle T. Giroux, PhD
Phone
519-432-8353
Ext
28255
Email
igiroux@uwo.ca
First Name & Middle Initial & Last Name & Degree
Gillian Mandich, BhSc
Phone
519-432-8353
Ext
28034
Email
gmandich@uwo.ca
First Name & Middle Initial & Last Name & Degree
Isabelle T. Giroux, PhD, RD

12. IPD Sharing Statement

Links:
URL
http://www.brescia.uwo.ca/prediabetes_initiative/
Description
Prediabetes Initiative and Partnership

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PREPARE: "Prediabetes Research and Education Promoting Activity & Responsible Eating"

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