在一项全饮食替代减重计划的临床试验中，在参与度、出席率和结果方面存在异质性。

Heterogeneity in the uptake, attendance, and outcomes in a clinical trial of a total diet replacement weight loss programme.

机构信息

Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford, OX26GG, UK.

NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

出版信息

BMC Med. 2020 Apr 16;18(1):86. doi: 10.1186/s12916-020-01547-4.

DOI:10.1186/s12916-020-01547-4

PMID:32295605

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7161206/

Abstract

BACKGROUND

Trials 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.

METHODS

We 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.

RESULTS

Men 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.

CONCLUSION

Despite 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 REGISTRATION

The DROPLET trial was prospectively registered on ISRCTN registry (ISRCTN75092026).

摘要

背景

试验表明，在初级保健中，全饮食替代（TDR）计划是安全有效的减肥方法。然而，目前尚不清楚参与者的特征是否会影响计划的参与度、出勤率或效果。

方法

我们使用了 272 名试验参与者的数据，这些参与者是通过他们的全科医生的一封信被邀请参加临床减肥试验的。我们使用 Cochran-Mantel-Haenszel 分析来评估接受参加试验的邀请是否因性别、年龄、BMI、社会贫困程度以及是否患有 2 型糖尿病或高血压而有所不同。我们使用混合广义线性模型来检查参与者的年龄、性别或居住地的社会贫困程度是否与 12 个月时的体重变化有关。

结果

与女性相比，男性的参与率较低（RR0.59[95%CI0.47,0.74]），而处于中高 BMI 三分位的参与者比处于低三分位的参与者更有可能参与（RR2.88[95%CI1.97,4.22]和 RR4.38[95%CI3.05,6.07]）。来自实践中最贫困和中等贫困三分位的患者比来自最贫困三分位的患者更有可能参与（RR1.84[95%CI1.81,2.59]和 RR1.68[95%CI1.18,2.85]）。没有证据表明年龄或 2 型糖尿病（RR1.10[95%CI0.81,1.50]）或高血压（RR0.81[95%CI0.62,1.04]）的预先诊断会影响参与。在 TDR 组中，13%的参与者为低参与度者，8%仅参与减肥阶段，79%参与减肥和体重维持阶段。那些参与整个计划的人减肥最多。亚组分析表明，年龄较大的参与者和基线 BMI 较高的参与者在 1 年内比对照组体重下降更多。