维持实质性治疗性体重减轻的饮食策略：78周混合方法随机试验

IF 7.4 2区医学 Q1 NUTRITION & DIETETICS

Clinical nutrition Pub Date : 2025-08-12 DOI:10.1016/j.clnu.2025.08.009

Naomi Brosnahan , Catherine Hankey , Anthony Leeds , Wilma Leslie , George Thom , Lisa Hutchison , Lindsay Govan , Hazel Ross , Michael E.J. Lean

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引用次数: 0

摘要

背景和目的：间歇性使用的低能量饮食（LED）可能有助于长期减肥维持（WLM）。这项研究比较了每周2天（5:2TDR）的总饮食替代和每天一次的膳食替代（DMR），在结构化的WLM计划中提供。方法在2016年4月12日至2018年6月5日期间招募的63名受试者（75%为女性，BMI 23-61 kg/m2）进行了一项为期78周的随机试验，这些受试者使用LED、行为计划或药物治疗实现了平均（SD）有意减重8kg。接受抗肥胖药物治疗的参与者要么体重稳定，要么在停药后体重恢复。主要结局是随机分组后26周的体重变化。6名营养师和25/63（40%）参与者在26周时完成了定性访谈。使用重复ANCOVA调整基线值，采用意向治疗、按方案治疗和按治疗方法评估组间差异。结果26周时，32/33（97%）随机分配到5:2TDR， 29/30（97%）随机分配到DMR，提供了数据。四名参与者接受了已有的药物治疗（n = 3奥利司他长达78周，n = 1利拉鲁肽长达52周）。研究前各组平均体重损失（SD）相似：5:2TDR - 15.0 (6.9) kg, DMR - 18.8 (9.3) kg, p = 0.056。WLM 26周后，意向治疗分析发现，tdr为5:2时，体重进一步减轻0.9 kg (95% CI为−2.9,1.5 kg)， DMR为3.5 kg (95% CI为1.3,5.5 kg)；组间差异- 4·4 kg (95% CI - 7·3,- 1·6 kg), p = 0.005。从研究开始前的体重减轻开始的26周，体重减轻为- 15.8 (9.5)kg (5:2TDR), - 15.2 (10.5) kg (DMR), p = 0.977。在per方案和处理分析中观察到类似的结果。在26、52和78周时，两组的体重都比基线低了15公斤。排除服用减肥药的患者，结果相似。这两种干预措施都被广泛接受。营养师成功地采用LED干预措施来克服参与者所面临的社会/环境挑战。结论：结构化饮食低脂饮食被广泛接受，可以防止大量减肥后的体重反弹，包括在胰高血糖素样肽-1激动剂停用后，并且可以维持15公斤的减肥至78周。

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Diet strategies for maintaining substantial therapeutic weight loss: 78-week mixed methods randomised trial

Background and aim

Formula low-energy diets (LED), used intermittently, may assist long-term weight-loss maintenance (WLM). This study compared total diet replacement 2 days/week (5:2TDR) and once-daily meal-replacements (DMR), delivered within a structured WLM programme.

Methods

A 78-week randomised trial was conducted in 63 individuals (75 % female, BMI 23–61 kg/m²), recruited between 12/04/2016 to 05/06/2018, after documented mean (SD) intentional weight-loss >8 kg, achieved using LED, behavioural programmes, or pharmacotherapy. Participants who had received anti-obesity medications were either weight stable or regaining after drug withdrawal. The primary outcome was weight change at 26-weeks following randomisation. Six dietitians and 25/63 (40 %) participants completed qualitative interviews at 26-weeks. Between-group differences were assessed using repeated ANCOVA adjusting for baseline values applying Intention-to-Treat, Per-Protocol, and As-Treated methods.

Results

At 26-weeks, 32/33 (97 %) randomised to 5:2TDR, and 29/30 (97 %) randomised to DMR, provided data. Four participants took pre-existing pharmacotherapy (n = 3 orlistat up to 78-weeks and n = 1 liraglutide up to 52-weeks). Mean (SD) pre-study weight-losses were similar between groups: 5:2TDR −15·0 (6·9) kg, DMR −18·8 (9·3) kg, p = 0.056. After 26-weeks WLM, intention-to-treat analysis found further weight-loss −0·9 kg (95 %CI −2·9, 1·5 kg) with 5:2TDR and regain with DMR 3·5 kg (95 %CI 1·3,5·5 kg); between-group difference −4·4 kg (95 %CI −7·3,−1·6 kg), p = 0·005. Maintained weight-losses at 26-weeks from pre-study start of weight loss were −15·8 (9·5) kg with 5:2TDR, −15·2 (10·5) kg with DMR, p = 0·977. Similar results were observed in the per protocol and as treated analyses. Both groups maintained weight losses >15 kg below baseline at 26, 52 and 78-weeks. Results were similar excluding those taking weight loss medications. Both interventions were well accepted. Dietitians successfully adapted LED interventions to overcome social/environmental challenges experienced by participants.

Conclusions

Structured dietary WLM is well accepted and can prevent weight regain after substantial loss, including after glucagon-like peptide-1 agonist withdrawal, and can maintain >15 kg loss up to 78-weeks

Trial registration

Clinicaltrials.gov: identifier NCT02683798.

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来源期刊

Clinical nutrition 医学-营养学

CiteScore

14.10

自引率

6.30%

发文量

356

审稿时长

28 days

期刊介绍： Clinical Nutrition, the official journal of ESPEN, The European Society for Clinical Nutrition and Metabolism, is an international journal providing essential scientific information on nutritional and metabolic care and the relationship between nutrition and disease both in the setting of basic science and clinical practice. Published bi-monthly, each issue combines original articles and reviews providing an invaluable reference for any specialist concerned with these fields.