Objectives To assess the feasibility of delivering and evaluating a weight management (WM) programme for overweight patients with a family history (FH) of breast cancer (BC) or colorectal cancer (CRC).
Study design A two-arm (intervention vs usual care) randomised controlled trial.
Setting National Health Service (NHS) Tayside and NHS Grampian.
Participants People with a FH of BC or CRC aged≥18 years and body mass index of ≥25 kg/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, four 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 was provided. Behavioural change techniques (motivational interviewing, action and coping plans and implementation intentions) were used.
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 psychosocial 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%) patients 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 were 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 and acceptable to participants, and indicative results suggest favourable outcomes.
Trial registration number ISRCTN13123470; Pre-results.
- cancer genetics
- nutritional support
- preventive medicine
- public health
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Contributors ASA and RJCS had the original idea for the study and, with JD, MM, ZM, NM, REO, MS, SV and JB, designed the trial parameters and formed the investigator group who obtained the funding. ASA, JB, JD, ZM, REO, SG and MS were responsible for overseeing study implementation and data collection. MM, REO and RST carried out the analysis. ASA and MM drafted the manuscript, which was revised by all authors. All authors approved the final paper and were independent from funders.
Funding This work was supported by Chief Scientist Office for Scotland, grant number CZH/4/1080.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical approval for this study was provided by East of Scotland Research Ethics Service (REC reference: 15/ES/0055).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Technical appendix, statistical code and dataset available from the authors on request.
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