Group vs. one to one dietetic interventions in lipid clinic version2.
Research type
Research Study
Full title
In adults with familial hypercholesterolaemia or familial combined hyperlipidaemia attending lipid clinic, are group dietetic interventions more effective than one to one? Establishing feasibility.
IRAS ID
169252
Contact name
Fraser Birrell
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
Familial hypercholesterolaemia (FH) and familial combined hyperlipidaemia (FCH) are inherited conditions which place those affected at high risk of heart disease. These patients are referred to lipid clinic. Clinical guidelines recommend that they receive individual dietary advice. However, it is still not clear what intensity, in what setting, and which behaviour change techniques this should contain.
Group interventions in other conditions have had some success. It is therefore proposed to carry out a feasibility study to determine if it is practical to carry out a large scale trial to answer the question: ‘In adults with FH and FCH, do group dietary interventions compared to one to one dietary interventions result in greater changes to diet?’
This feasibility study will be a non-randomised multicentre controlled trial. It aims to approach 200 participants to determine if sufficient people will take part, and go on to complete the study and its relevant questionnaires. The study will collect data on what would be in future studies the primary and secondary outcomes: changes to diet, smoking, and physical activity. As well as measuring acceptability of the intervention to patients.
Patients will be recruited from the waiting list of 3 lipid clinics in secondary care. New adult patients who are diagnosed with FH, possible FH, or FCH will be eligible. The study will last for 4 -11 weeks from informed consent to last contact. Participants will be asked to complete a 4 day online food diary and questionnaires on physical activity, smoking, and satisfaction of the intervention. The control group will receive standard care: 30 minute one to one consultation. The intervention group will receive 2 x 3 hour group sessions. The study is being completed as part of a Master of Clinical Research, funded by the National Institute for Health Research Clinical Academic Training Scheme.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0090
Date of REC Opinion
10 Feb 2015
REC opinion
Favourable Opinion