NCT01351181

Brief Summary

Type II diabetes is an important condition with a UK prevalence of 3.54% affecting approximately 2.5 million people across the country. Diabetics have a fivefold increased risk of cardiovascular disease and over 65% of diabetics will die from coronary heart disease or stroke. Exercise is one of the management tools along with medication and weight reduction available to improve diabetic control reducing morbidity and mortality. Exercise promotion might be more effective at a population level if it could be incorporated in a simple form as part of pre-existing routine care. This case control study seeks to assess the effectiveness of written exercise advice given to Type II diabetics at the time of their annual review. The study will be open to all Type II diabetics in a single general practice attending their routine nurse led annual review. The intervention uses leaflets prepared as part of a previous study the Time2Act study and assessment will be by self-reported questionnaires. Follow up will be over 12 months but the study design will allow for longer durations. Previous studies have demonstrated the effectiveness of exercise as an intervention but have often been hospital-based and used exercise interviews as the main intervention rather than incorporating exercise advice into structures already established in routine Primary Care. If this study demonstrates that a simple intervention carried out as part of routine care has a positive effect if only at a low level then disseminating this knowledge across the country would bring significant benefits to Type II diabetics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

1.5 years

First QC Date

May 9, 2011

Last Update Submit

May 9, 2011

Conditions

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

  • SPAQ score

    Increased Physical Activity

    12 months

Study Arms (2)

Exercise advice

EXPERIMENTAL

Behavioural

Behavioral: LeafletBehavioral: Exercise Advice

Normal Care

OTHER

Normal care

Behavioral: Normal Care

Interventions

LeafletBEHAVIORAL

Advice Leaflet

Exercise advice
Exercise AdviceBEHAVIORAL

Leaflet

Exercise advice
Normal CareBEHAVIORAL

Normal Care

Normal Care

Eligibility Criteria

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

You may qualify if:

  • Adult Type 2 diabetics

You may not qualify if:

  • non ambulatory
  • within 6 months diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ship Street Surgery

East Grinstead, Sussex, Rh19 4EA, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jerry D Hill, MRCGP

    National Health Service, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations