Walking Away: Structured Education Versus Written Information for Individuals With High Risk of Developing Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Written Information; Behavioral: Structured Education

• Registration Number: NCT00941954
• Lead Sponsor: University Hospitals, Leicester

Brief Summary

Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.

This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.

This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.

Primary research hypothesis: A pragmatic structured education programme aimed at promoting walking activity initiates long-term increases in physical activity in individuals identified through a risk score as having an increased risk of developing type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Study Start: 2009-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-07
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 833

Inclusion Criteria

• 18+
• High risk of developing type 2 diabetes as identified through a risk score

Exclusion Criteria

• Diagnosed diabetes
• Taking steroid medication
• Serious chronic illness preventing participation in trial
• Unable to speak English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Written Information	Written Information (booklet).
Lifestyle counseling	Structured Education	A group-based structured educational programme.

Primary Outcome Measures

Name	Time	Method
Change in ambulatory activity (walking)	12 months

Secondary Outcome Measures

Name	Time	Method
Depression	12 months; 24 months; 36 months
Visceral adiposity (sub-set of participants)	12 months; 24 months; 36 months
Muscle mass (sub-set of participants)	12 months; 24 months; 36 months
Health related quality of life	12 months; 24 months; 36 months
Change in ambulatory activity (walking)	24 months; 36 months
Light-, moderate- and vigorous-intensity physical activity	12 months; 24 months; 36 months
Time spent in sedentary activities	12 months; 24 months; 36 months
Fasting and 2-hour post-challenge plasma glucose	12 months; 24 months; 36 months
Standard anthropometric variables	12 months; 24 months; 36 months
Glycosylated hemoglobin (HbA1c)	12 months; 24 months; 36 months
Advanced glycation end products	12 months; 24 months; 36 months
Fasting and 2-hour post-challange plasma insulin	12 months; 24 months; 36 months
Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha)	12 months; 24 months; 36 months
C-reactive protein	12 months; 24 months; 36 months
Illness perceptions and efficacy beliefs	12 months; 24 months; 36 months

Trial Locations

Locations (1)

University Hospitals of Leicester (UHL); 🇬🇧 Leicester, United Kingdom