Randomised controlled trial to evaluate a behavioural educational strategy for adults with cystic fibrosis (Phase II)
| ISRCTN | ISRCTN67578749 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67578749 |
| Protocol serial number | N0542102367 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Papworth Hospital NHS Trust (UK) - NHS R&D Support Funding + Papworth Hospital Charitable Funds |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 09/09/2009
- 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
Mrs Helen Watson
Scientific
Scientific
Dietitians Department
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Weight gain |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 20 adults with cystic fibrosis |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 19/02/2003 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dietitians Department
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
