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

NCT01396772 | Unknown DMC

• 1 other identifier: GRT-2010-012
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months and 12 months after the baseline assessment

Secondary Outcomes (1)

• average number of physical activity minutes per day

  Baseline, 6 months and 12 months after the baseline assessment

Study Arms (2)

PREPARE education program

EXPERIMENTAL

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

Control arm

OTHER

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

Interventions

PREPARE education program BEHAVIORAL

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.

Also known as: Prediabetes Research and Education Program

PREPARE education program

standard of care presentation OTHER

A one-time 2-hour group prediabetes education session, offered as the standard for individuals referred for prediabetes in London, Ontario (Canada)

Also known as: Standard

Control arm

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brescia University College: lead

Study Sites (1)

Brescia University College

London, Ontario, N6G1H2, Canada

RECRUITING

Related Links

• Prediabetes Initiative and Partnership

MeSH Terms

Conditions

Prediabetic State; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Isabelle T. Giroux, PhD

  Brescia University College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle T. Giroux, PhD

CONTACT

519-432-8353; igiroux@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2013
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

CA (1)