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The aim was to assess whether TRE is non-inferior to individualised dietetic guidance (IDG) in changing HbA\n                      <jats:sub>1c<\/jats:sub>\n                      at 4 months in adults at risk of type 2 diabetes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In a two-arm, parallel-group, multi-centre randomised, non-inferiority clinical trial at two Australian clinical research institutes, adults at risk of type 2 diabetes (i.e. with overweight or obesity and a score of \u226515 on the Australian type 2 diabetes risk assessment tool) were recruited. Participants were randomly assigned using an electronic system (1:1) to TRE (9 h, self-selected eating window, last eating occasion by 19:00 hours) or IDG. Staff conducting assessments and analyses were blinded to allocation; participants and dietitians were unblinded. Both groups received five personalised telehealth consultations between 0 and 3 months (3 h total), specific to their allocated group. The primary outcome was the between-group difference for change in HbA\n                      <jats:sub>1c<\/jats:sub>\n                      at 4 months assessed via covariate linear regression using multiple imputation with a non-inferiority margin set at 1.1 mmol\/mol (0.10%). Secondary outcomes were change in HbA\n                      <jats:sub>1c<\/jats:sub>\n                      at 12 months and changes in fasting glucose, insulin, HOMA-IR and nocturnal glucose AUC. Exploratory outcomes included changes in cardiometabolic outcomes and body mass and composition. Adverse events were tracked for 12 months.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      One hundred and twenty four participants were randomised to TRE and 123 to IDG (mean \u00b1 SD HbA\n                      <jats:sub>1c<\/jats:sub>\n                      : 40 \u00b1 3 mmol\/mol [5.8 \u00b1 0.3%]). At 4 months, TRE was non-inferior but not superior to IDG for HbA\n                      <jats:sub>1c<\/jats:sub>\n                      (mean [95% CI]: \u22120.22 [\u22120.72, 0.30] mmol\/mol; \u22120.02 [\u22120.07, 0.03]%;\n                      <jats:italic>p<\/jats:italic>\n                      =0.40). At 12 months, the upper bound of the difference between groups was larger than the non-inferiority margin (0.10%) meaning that non-inferiority could no longer be concluded (mean [95% CI]: 0.47 [\u22120.19, 1.23] mmol\/mol; 0.05 [\u22120.02, 0.11]%;\n                      <jats:italic>p<\/jats:italic>\n                      =0.14). However, the absolute changes in HbA\n                      <jats:sub>1c<\/jats:sub>\n                      were small and not clinically meaningful in either group at either time point. Adverse events were minor and not different between interventions.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>TRE may offer a pragmatic and practical short-term alternative when access to dietetic support is limited, or if the approach is preferred by an individual.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov; NCT04762251<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>This research was funded by the Australian Government Medical Research Future Fund (MRFF 1200555).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06762-x","type":"journal-article","created":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T15:16:27Z","timestamp":1780758987000},"page":"2458-2471","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Time-restricted eating versus dietetic guidance on glycaemic outcomes in adults at risk of type 2 diabetes: a non-inferiority randomised clinical trial"],"prefix":"10.1007","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1710-6381","authenticated-orcid":false,"given":"Evelyn B.","family":"Parr","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0235-9087","authenticated-orcid":false,"given":"Rasha","family":"Charrouf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1776-4552","authenticated-orcid":false,"given":"Amy T.","family":"Hutchison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve A.","family":"Flint","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1387-0975","authenticated-orcid":false,"given":"Xiao Tong","family":"Teong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6428-1070","authenticated-orcid":false,"given":"Andrew D.","family":"Vincent","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-1561-1970","authenticated-orcid":false,"given":"Ana Paula","family":"Bravo-Garcia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8573-9979","authenticated-orcid":false,"given":"Zoe","family":"Siviour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6818-6065","authenticated-orcid":false,"given":"Gary A.","family":"Wittert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9180-5888","authenticated-orcid":false,"given":"Leah","family":"Brennan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9317-2351","authenticated-orcid":false,"given":"Brooke L.","family":"Devlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0886-9881","authenticated-orcid":false,"given":"John A.","family":"Hawley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2106-7303","authenticated-orcid":false,"given":"Leonie K.","family":"Heilbronn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,6]]},"reference":[{"issue":"10397","key":"6762_CR1","doi-asserted-by":"publisher","first-page":"203","DOI":"10.1016\/S0140-6736(23)01301-6","volume":"402","author":"KL Ong","year":"2023","unstructured":"Ong KL, Stafford LK, McLaughlin SA et al (2023) Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. 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Gleeson [ACU] and R. Jalleh [Northern Adelaide Local Health Network and Adelaide University]), as well as previous staff (B. Harvey and M. Jackson). We thank all the trial participants. Exploratory outcomes of body composition were presented in a poster at the European Congress of Obesity (ECO; Malaga, Spain) on 13 May 2025. Primary outcomes were orally presented at the European Association for the Study of Diabetes (EASD; Vienna, Austria) on 18 September 2025.","order":1,"name":"Ethics","label":"Acknowledgements","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"Anonymised data from this study are available on request from the corresponding author for 36 months from date of publication with a full research plan for academic use only. The data are not publicly available as they contain information that could compromise research participant consent.","order":2,"name":"Ethics","label":"Data availability","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"This research was funded by the Australian Government Medical Research Future Fund (MRFF 1200555). The Australian Government Medical Research Future Fund had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.","order":3,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.","order":4,"name":"Ethics","label":"Authors relationships and activities","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"EBP, ATH, BLD, ADV, GAW, LB, JAH and LKH contributed to the concept and design of the research. EBP, ATH, BLD, JAH and LKH obtained funding. EBP, ATH, RC, SAF, XTT, ADV, APB-G, ZS, BLD and LKH contributed to the acquisition, analysis and interpretation of data. ADV conducted the statistical analysis. EBP, ATH, JAH and LKH supervised postgraduate students. EBP, ATH, RC and LKH drafted the manuscript. All authors contributed to critical revision of the manuscript for important intellectual content, and provided administrative, technical or material support. All authors approved the final manuscript. LKH and JAH had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.","order":5,"name":"Ethics","label":"Contribution statement","group":{"name":"EthicsHeading","label":"Ethics"}}]}}