全科医疗中针对肥胖的限时进食（TRE）：巴登-符腾堡州研究实践网络（FoPraNet-BW）内一项对照随机实施研究（INDUCT）的研究方案

Time-restricted eating (TRE) for obesity in general practice: study protocol of a controlled, randomized implementation study (INDUCT) within the Research Practice Network Baden-Wuerttemberg (FoPraNet-BW).

作者信息

Braun Lorena, Haumann Hannah, Polanc Andreas, Koch Roland, Feil Elke, Klein Anika, Salm Claudia, Peters-Klimm Frank, Hübner Gudrun, Thies Christian, Biergans Stephanie, Joos Stefanie

机构信息

Institute for General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany.

Institute of General Practice, Medical Center, University of Freiburg, Freiburg, Germany.

出版信息

Nutr J. 2025 Mar 8;24(1):36. doi: 10.1186/s12937-025-01091-y.

DOI:10.1186/s12937-025-01091-y

PMID:40057785

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11889858/

Abstract

BACKGROUND

Obesity is a major health problem with a significant impact on quality of life and is a major risk factor for other diseases such as diabetes. There is a growing body of evidence that time-restricted eating (TRE) as one form of intermittent fasting (IF) represents a promising weight management strategy. Given the lack of evidence-based weight management strategies in the primary health care setting, the aim of this study is to investigate the effect of TRE in general practice in Germany.

METHODS

INDUCT is a type hybrid I, randomized-controlled study conducted in 41 practices within the newly established general practice-based research network (GPBRN) in Baden-Wuerttemberg (FoPraNet-BW). The study population consists of patients with a Body Mass Index between 30-45 kg (kg)/m. The intervention group receives TRE at the scheme 16:8 (16 h fasting; 8 h energy intake) while the control group receives care as usual. The primary outcome is change in body weight under a 6-month period of TRE. Secondary outcomes are related to the patient (e.g. quality of life) and the practice (e.g. knowledge about research in own practice). As the INDUCT study represents one of the first four use-cases within the Research Network Baden-Wuerttemberg (FoPraNet-BW), feasibility is a further secondary outcome. The target sample size is 208 patients with a 1:1 randomization. An intention-to-treat approach is used for data analysis.

DISCUSSION

INDUCT adds evidence on the effect of TRE as a weight management strategy in general practice. Relevant factors for a sustainable and successful implementation in general practice will be revealed and can be applied for future implementation of TRE interventions in general practice if proven successful. In addition, important lessons learned regarding the conduction of clinical research within FoPraNet-BW will be derived. This fosters a sustainable implementation of a research infrastructure in general practice in Germany. DRKS-ID (German Clinical Trials Register-ID): DRKS00031928 (Date of registration in DRKS: 2023-06-22; Link: https://drks.de/search/de/trial/DRKS00031928 ).

摘要

背景

肥胖是一个重大的健康问题，对生活质量有重大影响，并且是糖尿病等其他疾病的主要危险因素。越来越多的证据表明，限时进食（TRE）作为间歇性禁食（IF）的一种形式，是一种有前景的体重管理策略。鉴于初级卫生保健环境中缺乏基于证据的体重管理策略，本研究的目的是调查TRE在德国全科医疗中的效果。

方法

INDUCT是一项I型混合随机对照研究，在巴登-符腾堡州新建立的基于全科医疗的研究网络（FoPraNet-BW）内的41家诊所进行。研究人群包括体重指数在30至45千克/米²之间的患者。干预组按照16:8方案进行限时进食（禁食16小时；能量摄入8小时），而对照组接受常规护理。主要结局是在6个月的限时进食期间体重的变化。次要结局与患者（如生活质量）和诊所（如对自身诊所研究的了解）相关。由于INDUCT研究是巴登-符腾堡州研究网络（FoPraNet-BW）内的前四个用例之一，可行性是另一个次要结局。目标样本量为208名患者，随机分为1:1。数据分析采用意向性分析方法。

讨论

INDUCT为限时进食作为全科医疗中体重管理策略的效果增加了证据。将揭示在全科医疗中可持续且成功实施的相关因素，如果证明成功，可应用于未来全科医疗中限时进食干预的实施。此外，将得出关于在FoPraNet-BW内开展临床研究的重要经验教训。这促进了德国全科医疗中研究基础设施的可持续实施。德国临床试验注册编号（DRKS-ID）：DRKS00031928（在DRKS中的注册日期：2023年6月22日；链接：https://drks.de/search/de/trial/DRKS00031928 ）