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

Not Applicable

Completed

• Conditions: Prediabetic State
• Interventions: Behavioral: PREPARE with pedometer; Behavioral: PREPARE

• Registration Number: NCT00566319
• Lead Sponsor: University Hospitals, Leicester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Status Verified: 2007-11
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-03
• Study Completion: 2008-04
• Last Update Submitted: 2008-11-25
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	PREPARE with pedometer	-
2	PREPARE	-

Primary Outcome Measures

Name	Time	Method
2-hour glucose	2 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospitals of Leicester; 🇬🇧 Leicester, United Kingdom