Abstract
ObjectivesTo test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting.MethodsThis 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.InterventionsThe 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.ResultsOutcome 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).ConclusionsTreatment 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.
Highlights
The results from several international trials investigating the clinical effectiveness of programmes that combine low-energy total diet replacement (TDR) with behavioural support have consistently shown that these TDR programmes are an effective treatment for obesity [1,2,3,4,5,6]
Unlike most other recent TDR trials [2, 3, 6, 10], the DROPLET study tested the effectiveness of a TDR for routine treatment of obesity, rather than as a specific treatment aimed at diabetes remission
At the 3 year follow up we collected outcome data from 179 (66%) participants; 96 (72%) from the TDR group and 83 (62%) from usual care (UC) group respectively
Summary
The results from several international trials investigating the clinical effectiveness of programmes that combine low-energy total diet replacement (TDR) with behavioural support have consistently shown that these TDR programmes are an effective treatment for obesity [1,2,3,4,5,6]. They promote rapid weight loss over 12–16 weeks and lead to significant and substantial weight loss at 1 year compared with behavioural weight-loss programmes which do not include meal replacements.
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