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Community-based Sport Programme and Type 2 Diabetes (Fit4Life)

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ClinicalTrials.gov Identifier: NCT02548702
Recruitment Status : Not yet recruiting
First Posted : September 14, 2015
Last Update Posted : September 14, 2015
Sponsor:
Collaborators:
Community Sport Trust
Sport Nottinghamshire
Sport England
NHS Nottingham City Clinical Commissioning Group
NHS North and East Nottinghamshire Clinical Commissioning Group
NHS West Nottinghamshire Clinical Commissioning Group
NHS Rushcliffe Clinical Commissioning Group
Nottingham City Council
Nottinghamshire County Council
Information provided by (Responsible Party):
Prof. Mary Nevill, Nottingham Trent University

Brief Summary:

The Fit4Life intervention aims to engage inactive patients with type 2 diabetes in a community-based sport intervention, with the aim being that all participants complete 1 x 30 min session of physical activity/exercise per week across the 12 months they are involved in the intervention (total study duration 3 years).

The aim of the Fit4Life intervention is to slow the progression of disease symptoms and to improve quality of life in those diagnosed with type 2 diabetes. The aim of this research study is thus to evaluate the effectiveness of the intervention in achieving these aims. The hypothesis is that involvement in the Fit4Life programme will increase physical activity, reduce type 2 diabetes disease symptoms and enhance self-reported quality of life in male and female patients aged 35-64.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Fit4Life Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Community-based Sport Programme on Disease Symptoms and Quality of Life in Men and Women With Type 2 Diabetes
Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Community-based sport
Patients with type 2 diabetes will receive motivational counselling and will be allocated to a low intensity community-based sporting activity (Fit4Life programme) depending on their interests and perceived barriers to taking part.
Behavioral: Fit4Life
Fit4Life is a programme whereby patients with type 2 diabetes are counselled and then allocated to a community-based sport programme based on their interests and perceived barriers to participation

No Intervention: Control
One in 10 participants will be allocated to a control group who do not receive the intervention



Primary Outcome Measures :
  1. Change from baseline in number of participants reporting one or more sessions of sport per week measured by the UK Single Item Questionnaire [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Change from baseline in body mass (kg) [ Time Frame: 3 years ]
  2. Change from baseline in hip circumference (cm) [ Time Frame: 3 years ]
  3. Change from baseline in waist circumference [ Time Frame: 3 years ]
  4. Change from baseline in quality of life as measured by the quality of life survey (QOLS)(sum of 16 item 7 point likert scale) [ Time Frame: 3 years ]
  5. Change from baseline in control of blood glucose concentration as measured by self-report survey (subjective rating, 'better', 'the same', 'worse' [ Time Frame: 3 years ]
  6. Change from baseline in control of blood glucose concentration as measured by HPA1c (mmol/mol) [ Time Frame: 3 years ]


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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetic
  • inactive

Exclusion Criteria:

  • taking part in regular sport or physical activity (more than 30 minutes on one day per week)

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 ClinicalTrials.gov identifier (NCT number): NCT02548702


Contacts
Contact: Mary E Nevill, PhD 0115 8483918 mary.nevill@ntu.ac.uk
Contact: John G Morris, PhD 0115 8488058 john.morris@ntu.ac.uk

Locations
United Kingdom
Nottingham Trent University Not yet recruiting
Nottingham, United Kingdom, NG11 8NS
Contact: Mary E Nevill, PhD    0115 8483918    mary.nevill@ntu.ac.uk   
Contact: John G Morris, PhD    0115 8488058    john.morris@ntu.ac.uk   
Sponsors and Collaborators
Nottingham Trent University
Community Sport Trust
Sport Nottinghamshire
Sport England
NHS Nottingham City Clinical Commissioning Group
NHS North and East Nottinghamshire Clinical Commissioning Group
NHS West Nottinghamshire Clinical Commissioning Group
NHS Rushcliffe Clinical Commissioning Group
Nottingham City Council
Nottinghamshire County Council
Investigators
Principal Investigator: Mary E Nevill, PhD Nottingham Trent University

Publications:
Responsible Party: Prof. Mary Nevill, Professor and Head of Department of Sport Science, Nottingham Trent University
ClinicalTrials.gov Identifier: NCT02548702     History of Changes
Other Study ID Numbers: NTU2290
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

Keywords provided by Prof. Mary Nevill, Nottingham Trent University:
Sport
type 2 diabetes
community intervention programme
Fit4life
Exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases