Doctor Referral of Overweight People to Low Energy Treatment
A randomised controlled trial of a low energy liquid diet treatment compared with usual care for weight management in primary care. An individually randomised, two arm, parallel group design will be employed. The primary outcome will be an objective measurement of change in body weight. Patients’ participation in the study will last one year from randomisation to final follow-up. Consent will be sought for a later in-person follow-up at two years for all participants but this will be conducted only if a clinically meaningful difference between groups is observed at one year.
This trial follows the established model for GP referral to commercial group based weight loss programmes. It uses the generic authority and credibility of health professionals to motivate patients to consider weight management and the specialist knowledge of a commercial provider to guide the intervention and offer frequent contact and support to the patient. If successful, it will provide another effective option for weight management that can be offered to patients in primary care, and GPs will be able to guide patients towards the treatment which best fits their lifestyle and preferences. NICE currently recommends that patients who are considering using a commercial provider based in the community seek advice from their GP before starting a VLED (very low energy diet), in order to identify those for whom this type of diet would not be suitable.
This trial will specifically test whether a partnership between GPs and providers will allow for the safe provision of similar, low energy diets (810 kcal/d) even for patients with multi-morbidity who may gain the greatest benefits from such interventions but who may also need clinical oversight and adjustments to some of their medications as they lose weight. It will provide the opportunity for qualitative research to investigate the perspectives on this form of treatment by patients and health care practitioners and an assessment of cost effectiveness.
|Study Design:||Randomised, two-arm, parallel group controlled trial|
|Sponsor:||University of Oxford|
|Ethical Approval:||REC: 15/SC/0337|
|Chief Investigator:||Professor Susan Jebb, University of Oxford|