Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes (PREPARE)
Primary Purpose
Prediabetic State
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PREPARE with pedometer
PREPARE
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetic State focused on measuring Exercise
Eligibility 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
Sites / Locations
- University Hospitals of Leicester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
2-hour glucose
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
Full Information
NCT ID
NCT00566319
First Posted
November 30, 2007
Last Updated
November 25, 2008
Sponsor
University Hospitals, Leicester
Collaborators
Diabetes UK
1. Study Identification
Unique Protocol Identification Number
NCT00566319
Brief Title
Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes
Acronym
PREPARE
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 Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospitals, Leicester
Collaborators
Diabetes UK
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
PREPARE with pedometer
Intervention Description
Structured educational programme with pedometer use
Intervention Type
Behavioral
Intervention Name(s)
PREPARE
Intervention Description
Structured educational programme
Primary Outcome Measure Information:
Title
2-hour glucose
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Davies, MD
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Leicester
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21672008
Citation
Yates T, Davies MJ, Sehmi S, Gorely T, Khunti K. The Pre-diabetes Risk Education and Physical Activity Recommendation and Encouragement (PREPARE) programme study: are improvements in glucose regulation sustained at 2 years? Diabet Med. 2011 Oct;28(10):1268-71. doi: 10.1111/j.1464-5491.2011.03357.x.
Results Reference
derived
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Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes
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