Study Design: A two arm (intervention versus usual care) RCT
Setting: NHS Tayside and NHS Grampian
Participants: People with a FH of BC or CRC aged >18 years and Body Mass Index >25kg/m2 referred to NHS genetic services
Intervention: Participants were randomised to a control (lifestyle booklet) or 12 week intervention arm where they were given one face to face counselling session, 4 telephone consultations and web based support. A goal of 5% reduction in body weight was set and a personalised diet and physical activity (PA) programme provided. Behavioural change techniques (motivational interviewing, action and coping plans and implementation intentions) were utilised.
Primary outcome: Feasibility measures – recruitment, programme implementation, fidelity measures, achieved measurements and retention, participant satisfaction assessed by questionnaire and qualitative interviews.
Secondary outcomes: Measured changes in weight and PA and reported diet and psycho-social measures between baseline and 12 week follow-up.
Results: Of 480 patients approached, 196 (41%) expressed interest in the study and of those 78 (40%) were randomised. Implementation of the programme was challenging within the time allotted and fidelity to the intervention modest (62%). Qualitative findings indicated the programme was well received. Questionnaires and anthropometric data were completed by >98%. Accelerometer data was attained by 84% and 54% at baseline and follow up respectively. Retention at 12 weeks was 76%. Overall, 36% of the intervention group (vs 0% in control) achieved 5% weight loss. Favourable increases in PA and reduction in dietary fat were also reported.
Conclusions: A lifestyle programme for people with a family history of cancer is feasible to conduct, acceptable to participants and indicative results suggest favourable outcomes.
- Cancer genetics
- Nutritional support
- Preventive medicine
- Public health