Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/03/2011
Date assigned
07/04/2011
Last edited
18/04/2012
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 Robert Hurling

ORCID ID

Contact details

Unilever Discover
Colworth Science Park
Sharnbrook
Bedfordshire
MK44 1LQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UCR2008-1016

Study information

Scientific title

An exploratory study on the effects of online risk communication and planning on lifestyle behaviour changes: a randomised controlled trial

Acronym

Study hypothesis

To assess the short-term effects of online risk communication and planning on saturated fat intake changes

The specific hypothesis was:
A combined risk communication message and planning will lead to greater reductions in saturated fat intake changes than the control group

Ethics approval

Independent Ethics Committee in Unilever; South of England approved on 04/12/2008

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lifestyle behaviour changes

Intervention

Four conditions:
1. A risk communication message group, in which participants received an online risk communication message
2. A planning condition, in which participants were requested to choose specific plans on how to reduce their saturated fat intake
3. A combined risk communication and planning condition
4. A control group, in which participants received information on a healthy diet low in saturated fats

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Saturated fat intake changes measured by a food frequency questionnaire and two self-perceived items. These items were measured at the begining of the week1 (baseline) and at week 5 (follow-up)

Secondary outcome measures

1. Intention to reduce saturated fat intake
2. Self-efficacy
3. Outcome expectancies
4. Risk perceptions

Overall trial start date

01/02/2009

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy Individuals:
1. Body mass index (BMI) equal or greater than 25
2. 30-60 years old
3. Male or female
4. Not diagnosed with a heart-condition (heart-attack or angina)
5. Not diagnosed with cancer
6. Willing to sign the online informed consent form
7. Computer and internet literate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. BMI < 24.9
2. < 30 years old
3. > 60 years old
4. Pregnant women
5. Diagnosed with cancer
6. Diagnosed with a heart-condition (heart-attack or angina)
7. Any other chronic disease of the major organs (e.g. kidney failure)
8. Not willing to sign online consent form
9. Not literate in use of computer and the internet

Recruitment start date

01/02/2009

Recruitment end date

01/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Unilever Discover
Bedfordshire
MK44 1LQ
United Kingdom

Sponsor information

Organisation

Unilever R&D (UK)

Sponsor details

Unilever Discover
Colworth Science Park
Sharnbrook
Bedfordshire
Bedfordshire
MK44 1LQ
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Unilever R&D (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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22126827

Publication citations

  1. Results

    Soureti A, Murray P, Cobain M, van Mechelen W, Hurling R, Web-based risk communication and planning in an obese population: exploratory study., J. Med. Internet Res., 2011, 13, 4, e100, doi: 10.2196/jmir.1579.

Additional files

Editorial Notes