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

NHS Trust

Status: Completed

Conditions: Prediabetic State

Treatments: Behavioral: PREPARE with pedometer; Behavioral: PREPARE

Study type: Interventional

Funder types: Other

Identifiers

NCT00566319

06/Q2502/29

BDA:RD05/0003159

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

1

Experimental group

Treatment:

Behavioral: PREPARE with pedometer

2

Active Comparator group

Treatment:

Behavioral: PREPARE