Community-based Sport Programme and Type 2 Diabetes
Fit4Life
Effect of a Community-based Sport Programme on Disease Symptoms and Quality of Life in Men and Women With Type 2 Diabetes
1 other identifier
interventional
4,032
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Oct 2015
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedSeptember 14, 2015
September 1, 2015
3.2 years
September 3, 2015
September 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in number of participants reporting one or more sessions of sport per week measured by the UK Single Item Questionnaire
3 years
Secondary Outcomes (6)
Change from baseline in body mass (kg)
3 years
Change from baseline in hip circumference (cm)
3 years
Change from baseline in waist circumference
3 years
Change from baseline in quality of life as measured by the quality of life survey (QOLS)(sum of 16 item 7 point likert scale)
3 years
Change from baseline in control of blood glucose concentration as measured by self-report survey (subjective rating, 'better', 'the same', 'worse'
3 years
- +1 more secondary outcomes
Study Arms (2)
Community-based sport
EXPERIMENTALPatients 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.
Control
NO INTERVENTIONOne in 10 participants will be allocated to a control group who do not receive the intervention
Interventions
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
Eligibility Criteria
You may qualify if:
- type 2 diabetic
- inactive
You may not qualify if:
- taking part in regular sport or physical activity (more than 30 minutes on one day per week)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nottingham Trent Universitylead
- Community Sport Trustcollaborator
- Sport Nottinghamshirecollaborator
- Sport Englandcollaborator
- Nottingham City Clinical Commissioning Groupcollaborator
- NHS North and East Nottinghamshire Clinical Commissioning Groupcollaborator
- NHS Lincolnshire West Clinical Commissioning Groupcollaborator
- NHS Rushcliffe Clinical Commissioning Groupcollaborator
- Nottingham City Councilcollaborator
- Nottinghamshire County Councilcollaborator
Study Sites (1)
Nottingham Trent University
Nottingham, NG11 8NS, United Kingdom
Related Publications (2)
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PMID: 12900694BACKGROUNDLee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
PMID: 22018588BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary E Nevill, PhD
Nottingham Trent University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Head of Department of Sport Science
Study Record Dates
First Submitted
September 3, 2015
First Posted
September 14, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2018
Study Completion
June 1, 2019
Last Updated
September 14, 2015
Record last verified: 2015-09