Plain English Summary
Background and study aims
The aim of the study is to look at genetic, behavioural and environmental factors relating to obesity and diabetes in a group of 10,000 people born between 1950 and 1975.
Who can participate?
Men and women born between 1950 and 1975 registered at participating GP practices in the Fenland and East Cambridgeshire area
What does the study involve?
Interested applicants are invited to attend for a single visit at one of the MRC Epidemiology Unit testing centres. The visit lasts about three hours and includes measures of metabolic health, diet and other lifestyle patterns, body composition, fitness and physical activity. Follow-up visits take place at least 4 years later, in chronological order, so those that took part first of all were invited first.
What are the possible benefits and risks of participating?
The possible benefits of participating are receiving a very thorough health check including a test for diabetes and measurement of blood cholesterol. With the participants' permission their results will be passed to their GP and they will receive detailed individual feedback on the results from the tests. There is no risk involved in the tests.
Where is the study run from?
Addenbrooke's Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2004 to March 2021
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
Nick Wareham
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
N/A
Study information
Scientific title
The Fenland Study - a population-based cohort study of the interaction between environment and genetic factors in determining obesity, insulin sensitivity and hyperglycemia
Acronym
The Fenland study
Study hypothesis
The study is designed to investigate how common genetic variations interact with our dietary and physical activity patterns to determine the overall level of body fat and its distribution around the body and key indicators of metabolic health.
Ethics approval(s)
Current ethics approval as of 01/07/2022:
Phase 1:
Approved 11/05/2004, Cambridge Regional Ethics Committee, ref: 04/Q0108/19
Phase 2:
Approved 05/07/2014, NRES East of England – Cambridge East Research Ethics Committee, ref: 14/EE/0122
COVID 19:
Approved 30/06/2020, South West - Cornwall & Plymouth Research Ethics Committee, ref: 20/SW/0100
Previous ethics approval:
Phase 1: Cambridge Regional Ethics Committee, 11/05/2004, ref: 04/Q0108/19
Phase 2: NRES East of England – Cambridge East Research Ethics Committee, 05/07/2014, ref: 14/EE/0122
Study design
Single-centred observational cross-sectional cohort study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Other
Study type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Diabetes, obesity and other metabolic disorders
Intervention
Phase 1:
1. Oral glucose tolerance test
2. Measures of height, weight, waist and hip circumference and blood pressure
3. An ECG is carried out in order to provide information for exclusion from the treadmill test
4. Body fat is assessed by dual X-ray absorptiometry and ultrasonography
5. Habitual diet is assessed by questionnaire and biomarker analysis
6. Physical activity is assessed directly by using a combined sensor able to record heart rate and vertical acceleration. Individual calibration of heart rate and energy expenditure is carried out using a submaximal exercise test on a treadmill. Volunteers wear the sensor for 6 days following the visit to assess their habitual physical activity level
Added 13/05/2019:
Phase 2:
Follow-up visits took place at least 4 years after Phase 1, in chronological order, so those that took part first of all were invited first.
Intervention type
Other
Primary outcome measure
The study is designed to investigate how common genetic variations interact with our dietary and physical activity patterns to determine the overall level of body fat and its distribution around the body and key indicators of metabolic health. All outcomes are measured at the one-off visit. There are no follow-up visits involved in this study.
Secondary outcome measures
N/A
Overall study start date
01/12/2004
Overall study end date
31/03/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Men and women born between 1950-1975 registered at participating GP practices
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
10,000
Total final enrolment
10092
Participant exclusion criteria
1. Diagnosed diabetes
2. Psychotic illness
3. Terminal illness
4. Pregnancy
5. Unable to walk unaided
Recruitment start date
01/12/2004
Recruitment end date
31/12/2014
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
MRC Epidemiology Unit
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
University of Cambridge (UK)
Sponsor details
c/o Carolyn Read
Research Governance Officer
School of Clinical Medicine
Cambridge
CB2 0QQ
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Wellcome Trust (Ref: 074548)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Funder name
Medical Research Council
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
31/03/2021
Individual participant data (IPD) Intention to share
No
IPD sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/10/2015 | Yes | No | |
| Other publications | 14/03/2023 | 16/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |