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Randomized Controlled Trial
. 2018 Sep 26:362:k3760.
doi: 10.1136/bmj.k3760.

Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial

Nerys M Astbury  1 , Paul Aveyard  2 , Alecia Nickless  2 , Kathryn Hood  2 , Kate Corfield  2 , Rebecca Lowe  2 , Susan A Jebb  2
Affiliations
Randomized Controlled Trial

Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial

Nerys M Astbury et al. BMJ. .

Abstract

Objective: To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting.

Design: Pragmatic, two arm, parallel group, open label, individually randomised controlled trial.

Setting: 10 primary care practices in Oxfordshire, UK.

Participants: 278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months.

Interventions: The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction.

Main outcome measures: The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded.

Results: Participants in the TDR group lost more weight (-10.7 kg) than those in the usual care group (-3.1 kg): adjusted mean difference -7.2 kg (95% confidence interval -9.4 to -4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity.

Conclusions: Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease.

Trial registration: International Standard Randomised Controlled Trials No ISRCTN75092026.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: the trial was in part funded by Cambridge Weight Plan UK but the authors receive no personal financial benefit. The study was an investigator initiated protocol and the funder had no access to the data. The investigators had an independent right to publish the results of the trial regardless of outcome. PA and SAJ have previously conducted studies in which weight loss interventions were provided to the NHS by WeightWatchers, Slimming World, or Rosemary Conley.

Figures

Fig 1
Fig 1
Consort flowchart. BMI=body mass index; TDR=total diet replacement
Fig 2
Fig 2
Weight change over 12 months in intention to treat population. Values represent mean (standard error of the mean)
None
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