Recruiting

Prediabetes Research

Sponsor:

Brescia University College

Code:

NCT01396772

Conditions

Prediabetes

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

PREPARE education program

standard of care presentation

Study Details

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.

Conditions

Prediabetes

Study ID

NCT01396772

Start date

May, 2011

Status verified date

Jul, 2011

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

other: Control arm

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.

Interventions

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.

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)

Primary outcome measure

  • Average number of vegetable and fruit servings consumed per day [ Time Frame: Baseline, 6 months and 12 months after the baseline assessment ]

Central Contacts and Locations

Central contacts

Isabelle T. Giroux, PhD

519-432-8353igiroux@uwo.ca

Locations

Brescia University College

Recruiting

London, Ontario, Canada, N6G1H2

Contacts

Isabelle T. Giroux, PhD

519-432-8353igiroux@uwo.ca

Gillian Mandich, BhSc

519-432-8353gmandich@uwo.ca

Principal Investigator:

Isabelle T. Giroux, PhD, RD

More Information

Sponsor

Brescia University College

Last update posted

Jul 19, 2011

Last verified

Jul, 2011

Keywords

  • prediabetes
  • diabetes prevention
  • adults
  • lifestyle intervention
  • Social Cognitive Theory
  • dietary intake
  • physical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brescia University College on 2011-07-19.