ISRCTN ISRCTN60986572
DOI https://doi.org/10.1186/ISRCTN60986572
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number Nil known
Sponsor Medical Research Council Epidemiology Unit (UK)
Funder Medical Research Council Epidemiology Unit (UK)
Submission date
31/10/2007
Registration date
23/01/2008
Last edited
27/03/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nick Wareham
Scientific

Medical Research Council Epidemiology Unit
Institute of Metabolic Science
BOX 285
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled single-centre trial
Secondary study designRandomised controlled trial
Scientific titleThe Hertfordshire Physical Activity Trial
Study objectivesThe aim of the study is to determine whether differential responses to a physical activity training programme are seen between individuals with low birth weight compared to individuals with a normal birth weight.

More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?RecType=Unit&AgreementId=88572&CaseId=21340
Ethics approval(s)Ethics approval received from the Hertfordshire Local Research Ethics Committee on the 23rd May 2005 (ref: 05/Q0201/23).
Health condition(s) or problem(s) studiedMetabolic risk
InterventionAerobic exercise programme versus care as usual. The control group continue with their normal activities. The exercise group take part in a fully supervised 12- week aerobic exercise programme. There are three sessions each week and each one lasts sixty minutes.

Contact for queries:
Miss Jessica Horton
Email: Jessica.Horton@mrc-epid.cam.ac.uk
Intervention typeOther
Primary outcome measure(s)

Clustered Metabolic Risk Score.

Study participants return for their second visit thirteen weeks after their baseline visit. The outcomes will be measured at this time.

Key secondary outcome measure(s)

1. Body composition
2. Insulin sensitivity
3. Physical fitness

Study participants return for their second visit thirteen weeks after their baseline visit. The outcomes will be measured at this time.

Completion date01/03/2008

Eligibility

Participant type(s)Healthy volunteer
Age groupSenior
SexAll
Target sample size at registration100
Key inclusion criteria1. Healthy volunteers from the Hertfordshire Birth Cohort
2. Male and female, born between 1931 - 1939
Key exclusion criteria1. Diabetes
2. Untreated hypertension
3. Ischaemic heart disease
Date of first enrolment17/01/2007
Date of final enrolment01/03/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Medical Research Council Epidemiology Unit
Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2010 Yes No
Results article 25/03/2025 27/03/2025 Yes No
Protocol article protocol 19/06/2009 Yes No

Editorial Notes

27/03/2025: Publication reference added.