Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
03/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Daly

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 (0)1392 403086

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203178114

Study information

Scientific title

Acronym

Study hypothesis

To see whether lifestyle behaviour changes (weight loss and increased physical activity) similar to those obtained in recent large Finnish and US studies can be achieved with a simplified lifestyle intervention in a UK primary care setting. The intervention will use motivational interviewing (a well established, patient-centered behaviour counselling technique), delivered by trained health promotion worker (not necessarily existing NHS staff).

Ethics approval

Ethics approval added as of 16/07/2007:
North & East Devon Local Research Ethics Committee, approved in 2005 (ref: 05/Q2102/40)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Diabetes and heart disease

Intervention

Please note that the amendments to the target number of participants and participants - inclusion criteria (both amended as of 12/10/2007) reflect errors in information provided at time of registration, not changes in protocol.

Interventions added as of 16/07/2007:
1. Intervention group: Motivational interviews (patient-centered behaviour counseling) delivered by trained health promotion worker
2. Control group: Information leaflets offering advice on healthy eating and the benefits of increased physical activity

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Proportion of people achieving specific targets for weight change and physical activity which have been shown to be beneficial in previous studies.

Secondary outcome measures

Secondary outcome measures added as of 16/07/2007:
1. The proportion of participants achieving 150 min moderate activity per week
2. Waist circumference
3. Achievement of dietary composition targets (<30% energy from fat [<10% energy from saturated fat], 15 g / 1000 kcal fibre), if sufficient food diary data returned

Overall trial start date

30/11/2005

Overall trial end date

20/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria amended as of 12/10/2007:
1. Patients with a recorded BMI of 28 or more in the last 10 years
2. Age of 18 or more
3. Participants must be able to engage in at least moderate physical activity (e.g. no significant joint problems)
4. Participation will be restricted to those speaking English fluently, as the intervention is based on communication, and many of the measures are specifically validated for English speakers

Inclusion criteria provided at time of registration:
Identification of potential participants will be by computer searching of GP practice databases by NHS staff employed at the practice (e.g. practice nurse, clerical staff). This will generate a list of patients with a recorded BMI of 30 or more in the last 10 years, and age of 30 or more. A random selection of 420 patients will be identified by applying random numbers generated by the principal researcher. This list will be checked by the patient's GP for exclusion criteria.
Participants must also be able to engage in at least moderate physical activity (e.g. no significant joint problems). Participation will be restricted to those speaking English fluently, as the intervention is based on communication, and many of the measures are specifically validated for English speakers. For pragmatic reasons it is not possible to pay for interpreters for this study, although this would be considered for a larger trial.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Target number of participants amended as of 12/10/2007: 150 (141 participants were enrolled). Target number provided at time of registration: 420.

Participant exclusion criteria

Existing diabetes or heart disease, or any other reason the GP thinks the patient is not suitable for the intervention (e.g. severe uncontrolled hypertension, dementia or mental illness preventing likely understanding of the intervention or of the research processes).

Recruitment start date

30/11/2005

Recruitment end date

20/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Devon Primary Care Trust (UK)

Sponsor details

Dean Clarke House
Southernhay East
Exeter
EX1 1PQ
United Kingdom
+44 (0)1392 687194
Pam.deClive-Lowe@Exeter-PCT.nhs.uk

Sponsor type

Government

Website

http://www.swpctresearch.nhs.uk/

Funders

Funder type

Government

Funder name

Royal Devon and Exeter NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mid Devon Primary Care Research Group (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS Research and Development Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes