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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 30, 2007

Last Updated Date

November 25, 2008

Start Date ^†

October 2006

Current Primary Outcome Measures ^†

2-hour glucose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00566319 on ClinicalTrials.gov Archive Site

Current 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 [ Time Frame: Pedometer counts, 7 days ; everything else, 2 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Factorial Assignment

Condition ^†

Prediabetic State

Intervention ^†

Behavioral: PREPARE with pedometer
Behavioral: PREPARE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

103

Completion Date

April 2008

Primary Completion Date

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
Pregnant

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00566319

Responsible Party

Prof. Melanie Davies, University of Leicester

Secondary IDs ^††

BDA:RD05/0003159

Study Sponsor ^†

University Hospitals, Leicester

Collaborators ^††

Diabetes UK

Investigators ^†

Principal Investigator:

Melanie Davies, MD

University of Leicester

Information Provided By

University Hospitals, Leicester

Verification Date

November 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.