Trial record 2 of 690 for:    prediabetes

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Brescia University College.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brescia University College
ClinicalTrials.gov Identifier:
NCT01396772
First received: July 18, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Prediabetes
Behavioral: PREPARE education program
Other: standard of care presentation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Brescia University College:

Primary Outcome Measures:
  • Average number of vegetable and fruit servings consumed per day [ Time Frame: Baseline, 6 months and 12 months after the baseline assessment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 6 months and 12 months after the baseline assessment ] [ Designated as safety issue: No ]
    Data collected using a 7-Day Physical Activity and Step Log standard form.


Estimated Enrollment: 240
Study Start Date: May 2011
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396772

Contacts
Contact: Isabelle T. Giroux, PhD 519-432-8353 ext 28255 igiroux@uwo.ca

Locations
Canada, Ontario
Brescia University College Recruiting
London, Ontario, Canada, N6G1H2
Contact: Isabelle T. Giroux, PhD    519-432-8353 ext 28255    igiroux@uwo.ca   
Contact: Gillian Mandich, BhSc    519-432-8353 ext 28034    gmandich@uwo.ca   
Principal Investigator: Isabelle T. Giroux, PhD, RD         
Sponsors and Collaborators
Brescia University College
Investigators
Principal Investigator: Isabelle T. Giroux, PhD Brescia University College
  More Information

Additional Information:
No publications provided

Responsible Party: Isabelle Giroux, Ph.D., R.D., B.Ed., P.H.Ec., Associate Professor, Brescia University College, affiliated with The University of Western Ontario
ClinicalTrials.gov Identifier: NCT01396772     History of Changes
Other Study ID Numbers: GRT-2010-012
Study First Received: July 18, 2011
Last Updated: July 18, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Brescia University College:
prediabetes
diabetes prevention
adults
lifestyle intervention
Social Cognitive Theory
dietary intake
physical activity

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014