Frontiers in clinical diabetes and healthcare最新文献

{"title":"Barriers to and enablers of type 2 diabetes screening among women with prior gestational diabetes: A qualitative study applying the Theoretical Domains Framework.","authors":"Amelia J Lake, Amelia Williams, Adriana C H Neven, Jacqueline A Boyle, James A Dunbar, Christel Hendrieckx, Melinda Morrison, Sharleen L O'Reilly, Helena Teede, Jane Speight","doi":"10.3389/fcdhc.2023.1086186","DOIUrl":"10.3389/fcdhc.2023.1086186","url":null,"abstract":"<p><strong>Introduction: </strong>Women with previous gestational diabetes mellitus (GDM) are at increased risk of type 2 diabetes (T2D). Guidelines recommend postnatal diabetes screening (oral glucose tolerance test or HbA1c) typically 6-12 weeks after birth, with screening maintained at regular intervals thereafter. Despite this, around half of women are not screened, representing a critical missed opportunity for early identification of prediabetes or type 2 diabetes. While policy and practice-level recommendations are comprehensive, those at the personal-level primarily focus on increasing screening knowledge and risk perception, potentially missing other influential behavioral determinants. We aimed to identify modifiable, personal-level factors impacting postpartum type 2 diabetes screening among Australian women with prior gestational diabetes and recommend intervention functions and behavior change techniques to underpin intervention content.</p><p><strong>Research design and methods: </strong>Semi-structured interviews with participants recruited via Australia's National Gestational Diabetes Register, using a guide based on the Theoretical Domains Framework (TDF). Using an inductive-deductive approach, we coded data to TDF domains. We used established criteria to identify 'important' domains which we then mapped to the Capability, Opportunity, Motivation-Behavior (COM-B) model.</p><p><strong>Results: </strong>Nineteen women participated: 34 ± 4 years, 19 ± 4 months postpartum, 63% Australian-born, 90% metropolitan, 58% screened for T2D according to guidelines. Eight TDF domains were identified: 'knowledge', 'memory, attention, and decision-making processes', 'environmental context and resources', 'social influences', 'emotion', 'beliefs about consequences', 'social role and identity', and 'beliefs about capabilities'. Study strengths include a methodologically rigorous design; limitations include low recruitment and homogenous sample.</p><p><strong>Conclusions: </strong>This study identified numerous modifiable barriers and enablers to postpartum T2D screening for women with prior GDM. By mapping to the COM-B, we identified intervention functions and behavior change techniques to underpin intervention content. These findings provide a valuable evidence base for developing messaging and interventions that target the behavioral determinants most likely to optimize T2D screening uptake among women with prior GDM. .</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9574146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A critical review of the relationship between type 1 diabetes mellitus, inhibition, and behavioral management.","authors":"Neville Dean Robertson, Elmari Deacon, Karel Botha","doi":"10.3389/fcdhc.2022.1080415","DOIUrl":"10.3389/fcdhc.2022.1080415","url":null,"abstract":"<p><p>Type 1 diabetes mellitus (T1DM) is a chronic and lifelong condition that requires adequate behavior management in order to meet desired health outcomes. The effects of T1DM on the neurocognitive functioning of affected individuals raise concerns about how the disease may influence executive functioning. Inhibition is a core component of executive functioning, and plays a vital role in self-regulation and the restriction of impulsive behaviors. Inhibition may thus play a vital role in the behavior management of people with T1DM. The aim of this study was to identify current gaps in existing knowledge regarding the relationship between T1DM, inhibition, and behavior management. This study employed a critical review design to analyze and synthesize the current scientific literature. Twelve studies were identified through an appraisal process, and the data extracted were thematically analyzed and integrated. The findings of this study indicate that a possible cycle arises between these three constructs, in which T1DM affects inhibition, inhibition affects behavior management, and poor behavior management affects inhibition. It is recommended that future research should focus more specifically on this relationship.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012078/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9219032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effective assay technologies fit for large-scale population screening of type 1 diabetes.","authors":"Xiaofan Jia, Liping Yu","doi":"10.3389/fcdhc.2022.1034698","DOIUrl":"10.3389/fcdhc.2022.1034698","url":null,"abstract":"<p><p>While worldwide prevention efforts for type 1 diabetes (T1D) are underway to abrogate or slow progression to diabetes, mass screening of islet autoantibodies (IAbs) in the general population is urgently needed. IAbs, the most reliable biomarkers, play an essential role in prediction and clinical diagnosis of T1D. Through laboratory proficiency programs and harmonization efforts, a radio-binding assay (RBA) has been well established as the current 'gold' standard assay for all four IAbs. However, in view of the need for large-scale screening in the non-diabetic population, RBA consistently faces two fundamental challenges, cost-efficiency and disease specificity. While all four IAbs are important for disease prediction, the RBA platform, with a separate IAb test format is laborious, inefficient and expensive. Furthermore, the majority of IAb positivity in screening, especially from individuals with single IAb were found to be low risk with low affinity. It is well documented from multiple clinical studies that IAbs with low affinity are low risk with less or no disease relevance. At present, two non-radioactive multiplex assays, a 3-assay ELISA combining three IAbs and a multiplex ECL assay combining all four IAbs, have been successfully used as the primary methods for general population screenings in Germany and the US, respectively. Recently, the TrialNet Pathway to Prevention study has been organizing an IAb workshop which aims to analyze the 5-year T1D predictive values of IAbs. A T1D-specific assay with high efficiency, low cost and requiring low volume of sample will definitely be necessary to benefit general population screening.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9573605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hyperinsulinemia: an early biomarker of metabolic dysfunction.","authors":"Rama A Vaidya,&nbsp;Sharvari Desai,&nbsp;Panchali Moitra,&nbsp;Sheryl Salis,&nbsp;Shubhada Agashe,&nbsp;Rekha Battalwar,&nbsp;Anushree Mehta,&nbsp;Jagmeet Madan,&nbsp;Soumik Kalita,&nbsp;Shobha A Udipi,&nbsp;Ashok B Vaidya","doi":"10.3389/fcdhc.2023.1159664","DOIUrl":"https://doi.org/10.3389/fcdhc.2023.1159664","url":null,"abstract":"<p><strong>Introduction: </strong>Hyperinsulinemia in the absence of impaired glucose tolerance and normal HbA1c is considered indicative of pre-diabetes. Very few Indian studies have focused on hyperinsulinemia particularly in young adults. The present study aimed to determine whether hyperinsulinemia may be present despite HbA1c being normal.</p><p><strong>Methods: </strong>This was a cross-sectional study conducted on adolescents and young adults aged 16-25 years living in Mumbai, India. The participants attended various academic institutions and were those who underwent screening as the first step of a clinical trial for studying the efficacy of almond intake in prediabetes.</p><p><strong>Results: </strong>Among this young population (n=1313), 4.2% (n=55) of the participants were found to be prediabetic (ADA criteria) and 19.7% of them had HbA1c levels between 5.7%-6.4%. However, almost, 30.5% had hyperinsulinemia inspite of normal blood glucose levels and normal HbA1c. Among those with HbA1c<5.7 (n=533), 10.5% (n=56) participants had fasting insulin>15 mIU/L and a higher percentage (39.4%, n=260) had stimulated insulin above 80 mIU/L. These participants had higher mean anthropometric markers than those with normal fasting and/or stimulated insulin.</p><p><strong>Conclusion: </strong>Hyperinsulinaemia in the absence of impaired glucose tolerance and normal HbA1c may provide a much earlier indicator of detection for risk of metabolic disease and progression to metabolic syndrome and diabetes mellitus.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10186728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9544499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nutrition education to type 1 diabetes patients: few changes over the time.","authors":"Aurélien Clerc","doi":"10.3389/fcdhc.2023.1243237","DOIUrl":"https://doi.org/10.3389/fcdhc.2023.1243237","url":null,"abstract":"COPYRIGHT © 2023 Clerc. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. TYPE Opinion PUBLISHED 29 August 2023 DOI 10.3389/fcdhc.2023.1243237","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10497213/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10296073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Psychological care of patients during the pancreas transplantation process: issues and prospects.","authors":"Vasiliki Galani,&nbsp;Orianne Villard,&nbsp;Valérie Olivier,&nbsp;Andrea Peloso,&nbsp;Philippe Compagnon,&nbsp;Fadi Haidar,&nbsp;Paco Prada","doi":"10.3389/fcdhc.2023.1205964","DOIUrl":"https://doi.org/10.3389/fcdhc.2023.1205964","url":null,"abstract":"<p><p>Pancreas transplantation for patients with type 1 diabetes is a therapeutic option when other treatments are not effective and physical complications occur. Psychological burden is prominent in patients, and non-adherence to treatment is often one manifestation of such difficulties. Time projection is an important factor affected by chronic disease. The prospect of transplantation has the potential to repair this disruption. It could re-establish a continuity in the patient's self and history, by connecting the future to a life that was only about past and present. Taking care of oneself, adhering to treatment, being part of a long-term therapeutic project and going through transplantation are all processes that need a good ability to self-project in time. This is specifically a domain of psychotherapeutic interventions. In this article, the psychological implications of pancreas transplantation for patients and caregivers alike will be discussed, as well as the role of the psychiatrist in the transplantation process.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10364445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9866499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automatic inference of hypoglycemia causes in type 1 diabetes: a feasibility study.","authors":"Aleksandr Zaitcev,&nbsp;Mohammad R Eissa,&nbsp;Zheng Hui,&nbsp;Tim Good,&nbsp;Jackie Elliott,&nbsp;Mohammed Benaissa","doi":"10.3389/fcdhc.2023.1095859","DOIUrl":"https://doi.org/10.3389/fcdhc.2023.1095859","url":null,"abstract":"<p><strong>Background: </strong>Hypoglycemia is the most common adverse consequence of treating diabetes, and is often due to suboptimal patient self-care. Behavioral interventions by health professionals and self-care education helps avoid recurrent hypoglycemic episodes by targeting problematic patient behaviors. This relies on time-consuming investigation of reasons behind the observed episodes, which involves manual interpretation of personal diabetes diaries and communication with patients. Therefore, there is a clear motivation to automate this process using a supervised machine learning paradigm. This manuscript presents a feasibility study of automatic identification of hypoglycemia causes.</p><p><strong>Methods: </strong>Reasons for 1885 hypoglycemia events were labeled by 54 participants with type 1 diabetes over a 21 months period. A broad range of possible predictors were extracted describing a hypoglycemic episode and the subject's general self-care from participants' routinely collected data on the Glucollector, their diabetes management platform. Thereafter, the possible hypoglycemia reasons were categorized for two major analysis sections - statistical analysis of relationships between the data features of self-care and hypoglycemia reasons, and classification analysis investigating the design of an automated system to determine the reason for hypoglycemia.</p><p><strong>Results: </strong>Physical activity contributed to 45% of hypoglycemia reasons on the real world collected data. The statistical analysis provided a number of interpretable predictors of different hypoglycemia reasons based on self-care behaviors. The classification analysis showed the performance of a reasoning system in practical settings with different objectives under F1-score, recall and precision metrics.</p><p><strong>Conclusion: </strong>The data acquisition characterized the incidence distribution of the various hypoglycemia reasons. The analyses highlighted many interpretable predictors of the various hypoglycemia types. Also, the feasibility study presented a number of concerns valuable in the design of the decision support system for automatic hypoglycemia reason classification. Therefore, automating the identification of the causes of hypoglycemia may help objectively to target behavioral and therapeutic changes in patients' care.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10150960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10049100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dopamine receptor agonists mechanism of actions on glucose lowering and their connections with prolactin actions.","authors":"Hung-Yu Chien,&nbsp;Su-Mei Chen,&nbsp;Wan-Chun Li","doi":"10.3389/fcdhc.2023.935872","DOIUrl":"https://doi.org/10.3389/fcdhc.2023.935872","url":null,"abstract":"<p><p>Robust experiment evidence suggests that prolactin can enhance beta-cell proliferation and increase insulin secretion and sensitivity. Apart from acting as an endocrine hormone, it also function as an adipokine and act on adipocytes to modulate adipogenesis, lipid metabolism and inflammation. Several cross-sectional epidemiologic studies consistently showed that circulating prolactin levels positive correlated with increased insulin sensitivity, lower glucose and lipid levels, and lower prevalence of T2D and metabolic syndrome. Bromocriptine, a dopamine receptor agonist used to treat prolactinoma, is approved by Food and Drug Administration for treatment in type 2 diabetes mellitus since 2009. Prolactin lowering suppress insulin secretion and decrease insulin sensitivity, therefore dopamine receptor agonists which act at the pituitary to lower serum prolactin levels are expected to impair glucose tolerance. Making it more complicating, studies exploring the glucose-lowering mechanism of bromocriptine and cabergoline have resulted in contradictory results; while some demonstrated actions independently on prolactin status, others showed glucose lowering partly explained by prolactin level. Previous studies showed that a moderate increase in central intraventricular prolactin levels stimulates hypothalamic dopamine with a decreased serum prolactin level and improved glucose metabolism. Additionally, sharp wave-ripples from the hippocampus modulates peripheral glucose level within 10 minutes, providing evidence for a mechanistic link between hypothalamus and blood glucose control. Central insulin in the mesolimbic system have been shown to suppress dopamine levels thus comprising a feedback control loop. Central dopamine and prolactin levels plays a key role in the glucose homeostasis control, and their dysregulation could lead to the pathognomonic central insulin resistance depicted in the \"ominous octet\". This review aims to provide an in-depth discussion on the glucose-lowering mechanism of dopamine receptor agonists and on the diverse prolactin and dopamine actions on metabolism targets.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9574143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of structured self-monitoring of blood glucose on clinical, behavioral, and psychosocial outcomes among adults with non-insulin-treated type 2 diabetes: a systematic review and meta-analysis.","authors":"Elizabeth Holmes-Truscott,&nbsp;Shaira Baptista,&nbsp;Mathew Ling,&nbsp;Eileen Collins,&nbsp;EIif I Ekinci,&nbsp;John Furler,&nbsp;Virginia Hagger,&nbsp;Jo-Anne Manski-Nankervis,&nbsp;Caroline Wells,&nbsp;Jane Speight","doi":"10.3389/fcdhc.2023.1177030","DOIUrl":"https://doi.org/10.3389/fcdhc.2023.1177030","url":null,"abstract":"<p><strong>Background: </strong>Self-monitoring of blood glucose (SMBG) is considered of little clinical benefit for adults with non-insulin-treated type 2 diabetes, but no comprehensive review of a structured approach to SMBG has been published to date.</p><p><strong>Purpose: </strong>To conduct a systematic review and meta-analysis of the impact of sSMBG on HbA1c, treatment modifications, behavioral and psychosocial outcomes, and; examine the moderating effects of sSMBG protocol characteristics on HbA1c.</p><p><strong>Data sources: </strong>Four databases searched (November 2020; updated: February 2022).</p><p><strong>Study selection: </strong>Inclusion criteria: non-randomized and randomized controlled trials (RCTs) and prospective observational studies; reporting effect of sSMBG on stated outcomes; among adults (≥18 years) with non-insulin-treated type 2 diabetes. Studies excluded if involving children or people with insulin-treated or other forms of diabetes.</p><p><strong>Data extraction and analysis: </strong>Outcome data extracted, and risk of bias/quality assessed independently by two researchers. Meta-analysis was conducted for RCTs, and moderators explored (HbA1c only).</p><p><strong>Data synthesis: </strong>From 2,078 abstracts, k=23 studies were included (N=5,372). Risk of bias was evident and study quality was low. Outcomes assessed included: HbA1c (k=23), treatment modification (k=16), psychosocial/behavioral outcomes (k=12). Meta-analysis revealed a significant mean difference favoring sSMBG in HbA1c (-0·29%, 95% CI: -0·46 to -0·11, k=13) and diabetes self-efficacy (0.17%, 95% CI: 0.01 to 0.33, k=2). Meta-analysis revealed no significant moderating effects by protocol characteristics.</p><p><strong>Limitations: </strong>Findings limited by heterogeneity in study designs, intervention characteristics, and psychosocial assessments.</p><p><strong>Conclusion: </strong>A small positive effect of sSMBG on HbA1c and diabetes self-efficacy was observed. Narrative synthesis of sSMBG intervention characteristics may guide future implementation.</p><p><strong>Prospero registration: </strong>https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020208857, identifier CRD42020208857.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10157033/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9784633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pragmatic lifestyle intervention for overweight and obese women with gestational diabetes mellitus (PAIGE2): A parallel arm, multicenter randomized controlled trial study protocol.","authors":"Emma McAuley,&nbsp;Olwen Fleck,&nbsp;Laura Cassidy,&nbsp;Bridie J Kemp,&nbsp;Gina Cupples,&nbsp;Bronagh Kelly,&nbsp;Rachel M Creighton,&nbsp;Una Graham,&nbsp;Helen Wallace,&nbsp;Chris C Patterson,&nbsp;David R McCance","doi":"10.3389/fcdhc.2023.1118509","DOIUrl":"https://doi.org/10.3389/fcdhc.2023.1118509","url":null,"abstract":"<p><strong>Background: </strong>The global epidemic of type 2 diabetes (T2D) and obesity has been translated into pregnancy, with approximately 18% of women being diagnosed worldwide with Gestational Diabetes Mellitus (GDM). Whilst preventive strategies have proven effective in the non-pregnant context, attrition rates are high and there is an urgent need to develop a customized, pragmatic lifestyle intervention for women both during and after pregnancy. Diet and exercise modification, behavioral support, and Commercial Weight Management Organizations have been strongly recommended to aid postpartum weight reduction for mothers with previous GDM, subsequently reducing their risk of developing obesity and T2D. This study, informed by a previous pilot study, aims to determine the effectiveness of a pragmatic pregnancy and postpartum lifestyle modification program for overweight women with previous GDM (PAIGE2) to reduce body weight at 12 months postpartum.</p><p><strong>Methods/design: </strong>This paper summarizes the protocol for the PAIGE2 study, which has been developed based on results from a pilot study (PAIGE). A six center, two parallel arm, 12-month, randomized controlled trial will be conducted across Northern Ireland and the Republic of Ireland (3 centers each), involving 340 women with GDM and body mass index ≥25 kg/m² recruited during pregnancy. The lifestyle intervention involves a one-hour virtual educational program (to take place at 32-36 weeks gestation). Postpartum, the intervention will include monthly phone calls, weekly motivational text messages, weekly step counts, and referral for three months to a Commercial Weight Management Organization (Slimming World). The control arm will receive usual care as offered by the local maternity hospital. The primary outcome is weight loss at 12 months postpartum. Study visits for anthropometric and clinical measurements, fasting blood samples, questionnaires pertaining to health, wellbeing and physical activity will take place at 6 weeks, 6- and 12-months postpartum. Focus groups will be conducted with intervention mothers' post-intervention to determine the acceptability of the study design including utility of a Commercial Weight Management Organization, feasibility of remote patient contact, family involvement and patient satisfaction.</p><p><strong>Discussion: </strong>The PAIGE2 study will address the gaps in previously conducted research and, if positive, has the potential to have major public health implications for the prevention of future GDM and subsequent T2D.</p><p><strong>Clinical trial registration: </strong>https://clinicaltrials.gov/ct2/show/NCT04579016?term=NCT04579016&draw=2&rank=1, identifier NCT04579016.</p>","PeriodicalId":73075,"journal":{"name":"Frontiers in clinical diabetes and healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10080069/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9282797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}