Physical Activity Advice in Diabetics at Annual Review (PAADAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351181
Recruitment Status : Unknown
Verified May 2011 by Ship Street Surgery.
Recruitment status was:  Not yet recruiting
First Posted : May 10, 2011
Last Update Posted : May 10, 2011
Information provided by:
Ship Street Surgery

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Leaflet Behavioral: Exercise Advice Behavioral: Normal Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Case Control Study to Assess the Effectiveness of Written Advice to Increase Physical Activity Given to Type II Diabetics by Nursing Staff During the Diabetic Annual Review in UK General Practice
Study Start Date : June 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exercise advice
Behavioral: Leaflet
Advice Leaflet
Behavioral: Exercise Advice
Normal Care
Normal care
Behavioral: Normal Care
Normal Care

Primary Outcome Measures :
  1. SPAQ score [ Time Frame: 12 months ]
    Increased Physical Activity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult Type 2 diabetics

Exclusion Criteria:

  • non ambulatory
  • within 6 months diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01351181

United Kingdom
Ship Street Surgery Not yet recruiting
East Grinstead, Sussex, United Kingdom, Rh19 4EA
Principal Investigator: Jerry D Hill         
Sponsors and Collaborators
Ship Street Surgery
Principal Investigator: Jerry D Hill, MRCGP National Health Service, United Kingdom

Responsible Party: Dr J D HILL, Ship Street Surgery Identifier: NCT01351181     History of Changes
Other Study ID Numbers: 007489
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011

Keywords provided by Ship Street Surgery: