E. Tsompanaki , P. Aveyard , R.J. Park , D.A. Koutoukidis
{"title":"低能量全膳食替代与行为支持对缓解 2 型糖尿病饮食紊乱的影响 (ARIADNE):非劣效随机对照试验方案","authors":"E. Tsompanaki , P. Aveyard , R.J. Park , D.A. Koutoukidis","doi":"10.1016/j.cct.2024.107542","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>The National Health Service (NHS) in England is currently piloting a weight loss programme for remission of newly diagnosed type 2 diabetes (T2D), where participants replace all food with low-energy nutritionally complete formula products for 12 weeks (total diet replacement, TDR) and receive behavioural support. In a clinical trial, this programme led to remission in nearly half the participants. However, this weight loss programme might also worsen disordered eating and prompt eating disorders in susceptible people. We aim to investigate if the TDR programme is non-inferior to standard care in terms of disordered eating in susceptible individuals.</p></div><div><h3>Methods</h3><p>Fifty six people with newly diagnosed T2D, BMI ≥ 27 kg/m<sup>2</sup>, and medium to high scores of disordered eating based on the Eating Disorders Examination questionnaire (EDE-Q) will be randomised 1:1 to TDR receiving remote weekly/bi-weekly dietetic support or standard care. Participants will be re-assessed remotely at 1, 3, 4, 6, and 12 months. The primary outcome will be the between-group difference in the score of the EDE-Q. If the sample size can be expanded to 150, we will reduce the non-inferiority boundary. Weight, glycated haemoglobin (HbA1c), impairment from disordered eating, and distress will be secondary outcomes. Using the recorded consultations, we will evaluate the process in observed changes in eating behaviour and disordered eating.</p></div><div><h3>Conclusions</h3><p>If TDR for T2D remission is deemed non-inferior to standard care, more people may enrol and benefit from T2D remission. If TDR exacerbates disordered eating, screening may reduce unintended harm.</p><p><strong>Trial Registration:</strong> <span>NCT05744232</span><svg><path></path></svg> (<span>ClinicalTrials.gov</span><svg><path></path></svg>, prospectively registered).</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The impact of low-energy total diet replacement with behavioural support for remission of type 2 diabetes on disordered eating (ARIADNE): Protocol for a non-inferiority randomised controlled trial\",\"authors\":\"E. Tsompanaki , P. Aveyard , R.J. Park , D.A. Koutoukidis\",\"doi\":\"10.1016/j.cct.2024.107542\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>The National Health Service (NHS) in England is currently piloting a weight loss programme for remission of newly diagnosed type 2 diabetes (T2D), where participants replace all food with low-energy nutritionally complete formula products for 12 weeks (total diet replacement, TDR) and receive behavioural support. In a clinical trial, this programme led to remission in nearly half the participants. However, this weight loss programme might also worsen disordered eating and prompt eating disorders in susceptible people. We aim to investigate if the TDR programme is non-inferior to standard care in terms of disordered eating in susceptible individuals.</p></div><div><h3>Methods</h3><p>Fifty six people with newly diagnosed T2D, BMI ≥ 27 kg/m<sup>2</sup>, and medium to high scores of disordered eating based on the Eating Disorders Examination questionnaire (EDE-Q) will be randomised 1:1 to TDR receiving remote weekly/bi-weekly dietetic support or standard care. Participants will be re-assessed remotely at 1, 3, 4, 6, and 12 months. The primary outcome will be the between-group difference in the score of the EDE-Q. If the sample size can be expanded to 150, we will reduce the non-inferiority boundary. Weight, glycated haemoglobin (HbA1c), impairment from disordered eating, and distress will be secondary outcomes. Using the recorded consultations, we will evaluate the process in observed changes in eating behaviour and disordered eating.</p></div><div><h3>Conclusions</h3><p>If TDR for T2D remission is deemed non-inferior to standard care, more people may enrol and benefit from T2D remission. If TDR exacerbates disordered eating, screening may reduce unintended harm.</p><p><strong>Trial Registration:</strong> <span>NCT05744232</span><svg><path></path></svg> (<span>ClinicalTrials.gov</span><svg><path></path></svg>, prospectively registered).</p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-04-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424001253\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424001253","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
The impact of low-energy total diet replacement with behavioural support for remission of type 2 diabetes on disordered eating (ARIADNE): Protocol for a non-inferiority randomised controlled trial
Introduction
The National Health Service (NHS) in England is currently piloting a weight loss programme for remission of newly diagnosed type 2 diabetes (T2D), where participants replace all food with low-energy nutritionally complete formula products for 12 weeks (total diet replacement, TDR) and receive behavioural support. In a clinical trial, this programme led to remission in nearly half the participants. However, this weight loss programme might also worsen disordered eating and prompt eating disorders in susceptible people. We aim to investigate if the TDR programme is non-inferior to standard care in terms of disordered eating in susceptible individuals.
Methods
Fifty six people with newly diagnosed T2D, BMI ≥ 27 kg/m2, and medium to high scores of disordered eating based on the Eating Disorders Examination questionnaire (EDE-Q) will be randomised 1:1 to TDR receiving remote weekly/bi-weekly dietetic support or standard care. Participants will be re-assessed remotely at 1, 3, 4, 6, and 12 months. The primary outcome will be the between-group difference in the score of the EDE-Q. If the sample size can be expanded to 150, we will reduce the non-inferiority boundary. Weight, glycated haemoglobin (HbA1c), impairment from disordered eating, and distress will be secondary outcomes. Using the recorded consultations, we will evaluate the process in observed changes in eating behaviour and disordered eating.
Conclusions
If TDR for T2D remission is deemed non-inferior to standard care, more people may enrol and benefit from T2D remission. If TDR exacerbates disordered eating, screening may reduce unintended harm.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.