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

This study has been completed.
Sponsor:
Collaborator:
Diabetes UK
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00566319
First received: November 30, 2007
Last updated: November 25, 2008
Last verified: November 2007
History of Changes
  Purpose

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 Intervention
Prediabetic State
 Behavioral: PREPARE with pedometer
Behavioral: PREPARE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • 2-hour glucose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: October 2006
Study Completion Date: April 2008
Arms Assigned Interventions
Experimental: 1 Behavioral: PREPARE with pedometer
Structured educational programme with pedometer use
Active Comparator: 2 Behavioral: PREPARE
Structured educational programme

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Hospitals, Leicester

Additional 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
Study First Received: November 30, 2007
Last Updated: November 25, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals, Leicester:
Exercise

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 June 18, 2013