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Completed

NCT Number: NCT00566319

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

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.

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Key information

Conditions

Prediabetic State Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leicester

Leicester, LE1 5WW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREPARE with pedometer

Behavioral

Structured educational programme with pedometer use

PREPARE

Behavioral

Structured educational programme

Primary outcomes

  1. 2-hour glucose

    Time frame: 2 hours

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

  • Diabetes UK

Registry information

Official study 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

Acronym: PREPARE

Important dates

Study start
2006
Study completion
2008
First posted
Dec 3, 2007
Registry last updated
Nov 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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