Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
09/09/2009
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

Mrs Helen Watson

ORCID ID

Contact details

Dietitians Department
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0542102367

Study information

Scientific title

Acronym

Study hypothesis

To see if adults with cystic fibrosis (CF), completing a home based nutrition education programme, will have an improved nutritional status, an improvement in nutrition knowledge and self efficacy regarding their ability to cope with a special diet, compared with those receiving standard care.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Cystic fibrosis

Intervention

Pilot study of 20 patients, randomly assigned to behavioural the intervention group or control. Patients randomised to the intervention group will be given a behavioural nutrition education programme, which is completed at home. It consists of 10, weekly structured sessions which cover the major nutrition topics, ie energy and fat, enzymes, malabsorption, vitamins and minerals and snacks. Intervention group patients will also attend four group workshops, to prompt interest and motivation. Control group patients will receive standard dietetic advice, from a single dietitian. All patients will be seen at the routine CF clinics at 3-monthly intervals, for 12 months. Outcome measures at 3, 6, 9 and 12 months: Nutritional status (Body Mass Index [BMI]), pulmonary status (forced expiratory volume in one second [FEV1]), general and specific Nutrition Knowledge questionnaires, dietary intake questionnaires, health related quality of life (HRQoL).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Weight gain

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/02/2003

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

20 adults with cystic fibrosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

19/02/2003

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dietitians Department
Cambridge
CB3 8RE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Papworth Hospital NHS Trust (UK) - NHS R&D Support Funding + Papworth Hospital Charitable Funds

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18442509

Publication citations

  1. Results

    Watson H, Bilton D, Truby H, A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis., J Am Diet Assoc, 2008, 108, 5, 847-852, doi: 10.1016/j.jada.2008.02.017.

Additional files

Editorial Notes