Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes (PREPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00566319
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : November 26, 2008
Diabetes UK
Information provided by:
University Hospitals, Leicester

Brief Summary:
This study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (IGT). The educational programme is designed to promote physical activity by targeting perceptions and knowledge of IGT, exercise self-efficacy, and self-regulatory skills. The study will also investigate whether the effectiveness of the educational programme at promoting self-regulatory skills and physical activity is enhanced by the inclusion of a pedometer and personalised step/day goals.

Condition or disease Intervention/treatment Phase
Prediabetic State Behavioral: PREPARE with pedometer Behavioral: PREPARE Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial to Investigate the Effect of a Structured Educational Programme on Physical Activity Levels and Glucose Tolerance in People With Impaired Glucose Tolerance
Study Start Date : October 2006
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Behavioral: PREPARE with pedometer
Structured educational programme with pedometer use

Active Comparator: 2 Behavioral: PREPARE
Structured educational programme

Primary Outcome Measures :
  1. 2-hour glucose [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Pedometer counts, Fasting glucose, total cholesterol, HDL-cholesterol, LDL- cholesterol, TNFα, IL-6, CRP, systolic and diastolic blood pressure, body mass, waist circumference, BMI, physical activity, psychological determinants [ Time Frame: Pedometer counts, 7 days ; everything else, 2 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 2-h blood glucose ≥ 7.8 mmol/l and < 11.1 mmol/l
  • Fasting plasma glucose < 7 mmol/l
  • BMI ≥ 25 kg/m2 (or 23 kg/m2 for those from a South Asian ethnic origin)
  • Aged 18 or over

Exclusion Criteria:

  • Taking medication known to significantly interfere with glucose tolerance
  • Participating in regular vigorous physical activity
  • Unable to participate in moderate intensity physical activity
  • Pregnant

Information from the National Library of Medicine

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 identifier (NCT number): NCT00566319

United Kingdom
University Hospitals of Leicester
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
Diabetes UK
Principal Investigator: Melanie Davies, MD University of Leicester

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Melanie Davies, University of Leicester Identifier: NCT00566319     History of Changes
Other Study ID Numbers: 06/Q2502/29
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: November 2007

Keywords provided by University Hospitals, Leicester:

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