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

University Hospitals, Leicester1 site in 1 country103 target enrollmentOctober 2006

ConditionsPrediabetic State

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prediabetic State
Sponsor: University Hospitals, Leicester
Enrollment: 103
Locations: 1
Primary Endpoint: 2-hour glucose
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

April 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

University Hospitals, Leicester

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

Outcomes

Primary Outcomes

2-hour glucose

Time Frame: 2 hours

Secondary Outcomes

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)