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

Sponsors and Collaborators:	University Hospitals, Leicester Diabetes UK
Information provided by:	University Hospitals, Leicester
ClinicalTrials.gov Identifier:	NCT00566319

Purpose

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	Intervention
Prediabetic State	Behavioral: PREPARE with pedometer Behavioral: PREPARE

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Factorial Assignment
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

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:

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

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 ]

Enrollment:	103
Study Start Date:	October 2006
Study Completion Date:	April 2008

Arms	Assigned Interventions
1: Experimental	Behavioral: PREPARE with pedometer Structured educational programme with pedometer use
2: Active Comparator	Behavioral: PREPARE Structured educational programme

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566319

Locations

United Kingdom
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

More Information

Responsible Party:	University of Leicester ( Prof. Melanie Davies )
Study ID Numbers:	06/Q2502/29, BDA:RD05/0003159
Study First Received:	November 30, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00566319
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals, Leicester:

Exercise

Study placed in the following topic categories:

Metabolic Diseases
Glucose Intolerance
Prediabetic State
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009