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

Prediabetic State Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566319
• Other study ID #: 06/Q2502/29
• Secondary ID: BDA:RD05/0003159
• Status: Completed
• Phase: N/A
• First received: November 30, 2007
• Last updated: November 25, 2008
• Start date: October 2006
• Est. completion date: April 2008

Study information

• Verified date: November 2007
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Behavioral:
• PREPARE with pedometer
Structured educational programme with pedometer use
• PREPARE
Structured educational programme

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals, Leicester	Diabetes UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-hour glucose		2 hours	No
Secondary	Pedometer counts, Fasting glucose, total cholesterol, HDL-cholesterol, LDL- cholesterol, TNFa, 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	No