Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes
PREPARE
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
2 other identifiers
interventional
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 30, 2007
CompletedFirst Posted
Study publicly available on registry
December 3, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedNovember 26, 2008
November 1, 2007
November 30, 2007
November 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-hour glucose
2 hours
Secondary Outcomes (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
Pedometer counts, 7 days ; everything else, 2 hours
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Taking medication known to significantly interfere with glucose tolerance
- Participating in regular vigorous physical activity
- Unable to participate in moderate intensity physical activity
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospitals, Leicesterlead
- Diabetes UKcollaborator
Study Sites (1)
University Hospitals of Leicester
Leicester, Leicester, LE1 5WW, United Kingdom
Related Publications (1)
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.
PMID: 21672008DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie Davies, MD
University of Leicester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 30, 2007
First Posted
December 3, 2007
Study Start
October 1, 2006
Study Completion
April 1, 2008
Last Updated
November 26, 2008
Record last verified: 2007-11