Clinical trial NCT00941954: Walking Away: Structured Education Versus Written Information for Individuals With High Risk of Developing Type 2 Diabetes
Official title: Walking Away From Type 2 Diabetes: a Cluster Randomized Controlled Trial to Investigate the Effect of Structured Education on Walking Activity in Those With a High Risk of Developing Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Physical activity
Diabetes
Prevention
Pedometer
Walking
Structured education
Randomized
Risk score
Impaired glucose regulation
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: National Institute for Health Research, United Kingdom
First posted: 2009-07-20
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in ambulatory activity (walking)
timeFrame: 12 months
Secondary outcomes:
measure: Light-, moderate- and vigorous-intensity physical activity
timeFrame: 12 months; 24 months; 36 months
measure: Time spent in sedentary activities
timeFrame: 12 months; 24 months; 36 months
measure: Fasting and 2-hour post-challenge plasma glucose
timeFrame: 12 months; 24 months; 36 months
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: 12 months; 24 months; 36 months
measure: Advanced glycation end products
timeFrame: 12 months; 24 months; 36 months
measure: Fasting and 2-hour post-challange plasma insulin
timeFrame: 12 months; 24 months; 36 months
measure: Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha)
timeFrame: 12 months; 24 months; 36 months
measure: C-reactive protein
timeFrame: 12 months; 24 months; 36 months
measure: Standard anthropometric variables
timeFrame: 12 months; 24 months; 36 months
measure: Visceral adiposity (sub-set of participants)
timeFrame: 12 months; 24 months; 36 months
measure: Muscle mass (sub-set of participants)
timeFrame: 12 months; 24 months; 36 months
measure: Illness perceptions and efficacy beliefs
timeFrame: 12 months; 24 months; 36 months
measure: Health related quality of life
timeFrame: 12 months; 24 months; 36 months
measure: Depression
timeFrame: 12 months; 24 months; 36 months
measure: Change in ambulatory activity (walking)
timeFrame: 24 months; 36 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester (UHL)
Study officials:
affiliation: University of Leicester; University Hospitals of Leicester NHS Trust
name: Melanie J Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
citation: Henson J, Edwardson CL, Morgan B, Horsfield MA, Khunti K, Davies MJ, Yates T. Sedentary Time and MRI-Derived Measures of Adiposity in Active Versus Inactive Individuals. Obesity (Silver Spring). 2018 Jan;26(1):29-36. doi: 10.1002/oby.22034.
citation: Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
citation: Yates T, Davies MJ, Henson J, Troughton J, Edwardson C, Gray LJ, Khunti K. Walking away from type 2 diabetes: trial protocol of a cluster randomised controlled trial evaluating a structured education programme in those at high risk of developing type 2 diabetes. BMC Fam Pract. 2012 May 29;13:46. doi: 10.1186/1471-2296-13-46.