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

NCT ID: NCT00566319

Last Updated: 2008-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-04-30

Brief Summary

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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

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Conditions

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Prediabetic State

Keywords

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Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PREPARE with pedometer

Intervention Type BEHAVIORAL

Structured educational programme with pedometer use

2

Group Type ACTIVE_COMPARATOR

PREPARE

Intervention Type BEHAVIORAL

Structured educational programme

Interventions

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PREPARE with pedometer

Structured educational programme with pedometer use

Intervention Type BEHAVIORAL

PREPARE

Structured educational programme

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diabetes UK

OTHER

Sponsor Role collaborator

University Hospitals, Leicester

OTHER

Sponsor Role lead

Responsible Party

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University of Leicester

Principal Investigators

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Melanie Davies, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

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University Hospitals of Leicester

Leicester, Leicester, United Kingdom

Site Status

Countries

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United Kingdom

References

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Yates T, Davies MJ, Sehmi S, Gorely T, Khunti K. The Pre-diabetes Risk Education and Physical Activity Recommendation and Encouragement (PREPARE) programme study: are improvements in glucose regulation sustained at 2 years? Diabet Med. 2011 Oct;28(10):1268-71. doi: 10.1111/j.1464-5491.2011.03357.x.

Reference Type DERIVED
PMID: 21672008 (View on PubMed)

Other Identifiers

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BDA:RD05/0003159

Identifier Type: -

Identifier Source: secondary_id

06/Q2502/29

Identifier Type: -

Identifier Source: org_study_id