Abstract

To test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting.

Methods

This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults with obesity.

The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years, analysed as intention-to-treat with mixed effects models.

Interventions The intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks.

Behavioural support was provided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support was provided.

The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months.

Results

Outcome measures were collected from 179 (66%) participants.

Compared with baseline, at 3 years the TDR group lost −6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7); adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p < 0.0001.

Regain from programme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference +6.9 kg (95% CI 4.2, 9.5) P < 0.001.

At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference −3.3 mmHg (95% CI:−6.2; −0.4) P = 0.024), and systolic blood pressure (mean differences −3.7 mmHg (95% CI: −7.4; 0.1) P = 0.057).

There was no evidence of differences between groups in the change from baseline to 3 years HbA1c (−1.9 mmol/mol (95% CI: −0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI −0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2) (−0.37 (95% CI −0.96; 0.22); P = 0.22).

Conclusions

Treatment of people with obesity with a TDR programme compared with support from a practice nurse leads to greater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in other aspects of cardiometabolic risk.

Citations

Nerys M. Astbury, Rhiannon M. Edwards, Fitsum Ghebretinsea, Milensu Shanyinde, Jill Mollison, Paul Aveyard & Susan A. Jebb .Extended follow-up of a short total diet replacement programme: results of the Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET) randomised controlled trial at 3 years. International Journal of Obesity (2021))

Sponsorship: Supported by the NIHR

DOI: https://doi.org/10.1038/s41366-021-00915-1

URI: https://www.oxfordhealth.nhs.uk/orka/title/extended-follow-up-of-a-short-total-diet-replacement-programme-results-of-the-doctor-referral-of-overweight-people-to-low-energy-total-diet-replacement-treatment-droplet-randomised-controlled-trial/