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

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ClinicalTrials.gov Identifier: NCT00566319
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : November 26, 2008
Sponsor:
Collaborator:
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00566319


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Melanie Davies, University of Leicester
ClinicalTrials.gov Identifier: NCT00566319     History of Changes
Other Study ID Numbers: 06/Q2502/29
BDA:RD05/0003159
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: November 2007

Keywords provided by University Hospitals, Leicester:
Exercise

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