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

Sponsor

University Hospitals, Leicester (Other)

Overall Status

Completed

CT.gov ID

NCT00566319

Collaborator

Diabetes UK (Other)

103

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prediabetic State	Behavioral: PREPARE with pedometer Behavioral: PREPARE	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Oct 1, 2006

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Behavioral: PREPARE with pedometer Structured educational programme with pedometer use
Active Comparator: 2	Behavioral: PREPARE Structured educational programme

Arm

Intervention/Treatment

Experimental: 1

Behavioral: PREPARE with pedometer

Structured educational programme with pedometer use

Active Comparator: 2

Behavioral: PREPARE

Structured educational programme

Outcome Measures

Primary Outcome Measures

2-hour glucose [2 hours]

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 [Pedometer counts, 7 days ; everything else, 2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals of Leicester	Leicester		United Kingdom	LE1 5WW

Sponsors and Collaborators

University Hospitals, Leicester
Diabetes UK

Investigators

Principal Investigator: Melanie Davies, MD, University of Leicester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00566319

Other Study ID Numbers:

06/Q2502/29
BDA:RD05/0003159

First Posted:

Dec 3, 2007

Last Update Posted:

Nov 26, 2008

Last Verified:

Nov 1, 2007

Keywords provided by , ,

Exercise

Additional relevant MeSH terms:

Prediabetic State

Study Results

No Results Posted as of Nov 26, 2008