Randomised controlled trial to evaluate a behavioural educational strategy for adults with cystic fibrosis (Phase II)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2003
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). CONDITION: Cystic fibrosis ; Nutritional, Metabolic, Endocrine ; Cystic fibrosis PRIMARY OUTCOME: Weight gain SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 20 adults with cystic fibrosis
Epistemonikos ID: 92e49d9c31240880ebd5b0760c8ecf9b28770cc5
First added on: Aug 21, 2024