NCT00941954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
833

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

4.3 years

First QC Date

July 16, 2009

Last Update Submit

September 7, 2015

Conditions

Diabetes

Keywords

Physical activityDiabetesPreventionPedometerWalkingStructured educationRandomizedRisk scoreImpaired glucose regulation

Outcome Measures

Primary Outcomes (1)

  • Change in ambulatory activity (walking)

    12 months

Secondary Outcomes (15)

  • 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

  • Glycosylated hemoglobin (HbA1c)

    12 months; 24 months; 36 months

  • Advanced glycation end products

    12 months; 24 months; 36 months

  • +10 more secondary outcomes

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

A group-based structured educational programme.

Behavioral: Structured Education

Control

ACTIVE COMPARATOR

Written Information (booklet).

Behavioral: Written Information

Interventions

Structured EducationBEHAVIORAL

The intervention group will be offered a group-based structured educational programme aimed at promoting increased ambulatory activity by targeting perceptions and knowledge of diabetes risk, physical activity self-efficacy, barriers to physical activity and self-regulatory skills based on pedometer use. The programme will employ a person-centred approach to patient education that is based on self-management programmes for individuals with type 2 diabetes and prediabetes that have been developed and tested by our research group. The programme will be designed to be delivered to 5-10 participants by two trained educators and is 3.5 hours long. Brief follow-up counselling will be offered once every 6 months.

Lifestyle counseling
Written InformationBEHAVIORAL

Control subjects will receive a booklet detailing information on risk factors for type 2 diabetes (T2DM) and cardiovascular disease (CVD) and how physical activity can be used to prevent T2DM and CVD.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester (UHL)

Leicester, LE5 4PW, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 31399440DERIVED

  • 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.

    PMID: 29265769DERIVED

  • 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.

    PMID: 25537783DERIVED

  • 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.

    PMID: 22642610DERIVED

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Melanie J Davies, MD

    University of Leicester; University Hospitals of Leicester NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 20, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

GB(1)