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ISRCTN
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ISRCTN67578749
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial to evaluate a behavioural educational strategy for adults with cystic fibrosis (Phase II)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0542102367
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cystic fibrosis
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Participants - inclusion criteria
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20 adults with cystic fibrosis
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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19/02/2003
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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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).
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Primary outcome measure(s)
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Weight gain
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cambridge Consortium - Papworth Hospital NHS Trust (UK) - NHS R&D Support Funding + Papworth Hospital Charitable Funds
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18442509
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Contact name
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Mrs
Helen
Watson
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Address
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Dietitians Department
Papworth Hospital NHS Trust
Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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09/09/2009
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Date ISRCTN assigned
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12/09/2003
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