Abstract

BackgroundTrials have shown total diet replacement (TDR) programmes are safe and effective for weight loss in primary care. However, it is not clear whether participant characteristics affect uptake, attendance, or effectiveness of the programme.MethodsWe used data from 272 trial participants who were invited to participate in a clinical weight loss trial via a letter from their GP. We used a Cochran-Mantel-Haenszel analysis to assess whether accepting an invitation to participate in the trial differed by gender, age, BMI, social deprivation, and the presence of a diagnosis of type 2 diabetes or hypertension. We used mixed generalised linear modelling to examine whether participants’ age, gender, or social deprivation based on area of residence were associated with weight change at 12 months.ResultsMen were less likely to enrol than women (RR 0.59 [95% CI 0.47, 0.74]), and people from the middle and highest BMI tertile were more likely to enrol than those from the lowest tertile (RR 2.88 [95% CI 1.97, 4.22] and RR 4.38 [95% CI 3.05, 6.07], respectively). Patients from practices located in most deprived and intermediate deprived tertiles were more likely to enrol compared with those in the least deprived tertile (RR 1.84 [95% CI 1.81, 2.59] and RR 1.68 [95% CI 1.18, 2.85], respectively). There was no evidence that age or a pre-existing diagnosis of type 2 diabetes (RR 1.10 [95% CI 0.81, 1.50]) or hypertension (RR 0.81 [95% CI 0.62, 1.04]) affected enrolment. In the TDR group, 13% of participants were low engagers, 8% engaged with the weight loss phase only, and 79% engaged in both weight loss and weight maintenance phases of the programme. Those who engaged in the entire programme lost most weight. Subgroup analyses suggested that older participants and those with a higher baseline BMI lost more weight at 1 year than their comparators.ConclusionDespite some heterogeneity in the uptake and outcomes of the programme, if the results of this trial are replicated in routine practice, there is no evidence that TDR weight loss programmes would increase inequity.Trial registrationThe DROPLET trial was prospectively registered on ISRCTN registry (ISRCTN75092026).

Highlights

  • Trials have shown total diet replacement (TDR) programmes are safe and effective for weight loss in primary care

  • We explore whether uptake, engagement, and outcomes of a TDR programme offered as part of a clinical trial differed in relation to participant characteristics or the presence of weight-related disease

  • Design and setting The Doctor Referral of Overweight People to Low-Energy total diet replacement Treatment (DROPLET) study was a randomised controlled, two-arm trial to determine the clinical and cost effectiveness of a primary care referral to commercial low-energy TDR programme delivered in the community, compared with usual weight management interventions offered by a practice nurse

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Summary

Introduction

Trials have shown total diet replacement (TDR) programmes are safe and effective for weight loss in primary care. Evidence from two recent randomised controlled trials shows that offering a TDR programme in primary care is safe and leads to substantial weight loss [1, 2] It is not clear whether participants in such trials are representative of the general practice population of people with obesity. The current mainstay of weight management support in the UK is referral to a behavioural weight loss programme, typically involving group sessions delivered in the community over 12 weeks [3] Previous evaluations of these programmes in clinical trials run in routine care settings have reported that women and people who are older and from less deprived areas are more likely to be enrolled [4, 5]. These same trials show no evidence of differences in weight loss in relation to participants’ gender, age, or deprivation, suggesting that participation in these programmes per se does not increase inequalities [6, 7]

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