Introduction

The global prevalence of gestational diabetes mellitus (GDM) ranges from 14% to 17% (equivalent to roughly one in six to seven pregnant women affected). However, marked regional disparities exist in its epidemiological and can be substantially higher in certain populations, such as South Asia and certain provinces in China.1–3 Characterized as glucose intolerance newly identified during gestation, GDM poses significant health risks to both pregnant women and their fetuses. Maternal complications include preeclampsia, cesarean delivery, and a significantly increased risk of developing type 2 diabetes later in life.4 For the offspring of GDM mothers, GDM increases the risk of macrosomia, neonatal hypoglycemia, and long-term susceptibility to obesity and metabolic syndrome.5 In addition to these physiological consequences, a confirmed GDM diagnosis acts as a major psychological stressor, frequently contributing to heightened levels of anxiety, depression, and diabetes-specific distress.6–8 This psychological burden can form a vicious cycle: stress and negative emotions may weaken patients’ adherence to structured self-management regimens, potentially leading to suboptimal glycemic control, which in turn exacerbates psychological distress.9

Current mainstream GDM management is primarily built on targeted lifestyle modifications—primarily consisting of medical nutrition therapy (MNT) and physical activity—combined with regular glucose monitoring and pharmacological therapy (eg, insulin) when clinically indicated.10 However, this standard management model focuses primarily on physiological aspects, while neglecting patients’ unmet psychological needs. This gap is clinically significant because chronic psychological stress triggers activation of the hypothalamic-pituitary-adrenal (HPA) axis, resulting in elevated cortisol secretion, which contributes to the development of insulin resistance and increased hepatic gluconeogenesis, ultimately hindering effective glycemic management.11 Therefore, an effective management strategy for GDM needs to address both the physiological abnormalities of glucose metabolism and the associated psychological distress in affected women.

MBSR, developed by Jon Kabat-Zinn, is a standardized, 8-week group program designed to train individuals to cultivate moment-to-moment, non-judgmental awareness.12 By enhancing attention regulation, emotion regulation, as well as self-awareness, MBSR helps individuals respond to stressors with greater flexibility and less reactivity. In the context of clinical diabetes management, accumulating clinical evidence supports the efficacy of MBSR and related mindfulness-based interventions. Systematic reviews and meta-analyses conducted in patients with type 2 diabetes have demonstrated that these interventions have been shown to result in statistically and clinically meaningful reductions in glycated hemoglobin (HbA1c), alongside substantial improvements in symptoms of depression, anxiety, diabetes-related distress, and overall well-being.13–15

Specifically within perinatal mental health, mindfulness-based interventions have shown promise in reducing pregnancy-related anxiety, depressive symptoms, and perceived stress among expectant mothers, indicating their applicability and acceptability in this population.16,17 Despite robust evidence in the broader diabetes populations, the application of MBSR specifically in GDM remains relatively under explored, forming an urgent research gap. A small number of pioneering studies have suggested the potential benefits of mindfulness-based interventions in GDM. For instance, an intervention study by Zeinabeh et al (2023) reported that MBSR intervention significantly reduced both blood glucose levels and perceived stress levels in women with GDM.18 However, existing relevant studies are restricted by inherent methodological limitations, including small sample sizes (eg, Zeinabeh et al, 2023, included only 60 participants), lack of active control design groups, and insufficient blinding measures, thereby greatly weaken the credibility of causal inferences.18 Notably, no large-scale, methodologically rigorous randomized controlled trial (RCT) has specifically evaluated the full-course, standardized MBSR program with respect to the primary outcome of glycemic control (HbA1c) in GDM, while concurrently examining its impact on comprehensive psychological outcomes and maternal-infant health endpoints.

To fill this prominent research gap, we hereby designed this randomized controlled trial protocol. The primary objective is to evaluate the efficacy of an 8-week MBSR program, delivered as an add-on to routine GDM care, in improving glycemic control and psychological well-being among women with GDM. The primary hypothesis is that, in comparison to those undergoing standard care plus an attention-controlled health education, those receiving standard care plus MBSR will attain a more pronounced reduction in HbA1c concentrations from baseline to post-intervention follow-up. Secondary hypotheses presume that the MBSR group will show greater improvements in psychological indices (anxiety, depression, diabetes distress, mindfulness), self-management performance, and favorable maternal-neonatal clinical outcomes. Exploratory analyses will further explore the potential mediating roles of reduced perceived stress and improved self-management behaviors.

Methods Study Flow

A flowchart in Figure 1 illustrates participant progression across enrollment, intervention, follow-up, and data analysis phases of this assessor-blinded, parallel-group randomized controlled trial are presented. The diagram systematically depicts the sequential process from screening and randomization of eligible pregnant women with GDM to allocation into the intervention (standard care + MBSR) or active control (standard care + health education) groups, through the three assessment time points (baseline, post-intervention, and postpartum), concluding with data analysis.

Figure 1 Participant flow chart.

Study Design

This study is a prospective, two-arm, parallel-group, RCT with assessor blinding. Eligible participants will be randomly divided into the MBSR group and the Control group at a 1:1 ratio. The clinical study will be conducted at the Fujian Maternity and Child Health Hospital over an 18-month period. The study protocol has been approved by the Hospital’s Ethics Committee (Approval Number:2025KY301) and registered with the Chinese Clinical Trial Registry (ChiCTR Registration 2600116078) prior to implementation. The design and reporting of this trial will be conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. This protocol has been prepared in accordance with the SPIRIT 2025 guidelines.

The full trial protocol and the detailed statistical analysis plan (SAP) are accessible upon legitimate application from the corresponding author. Key methodological information is recorded in the trial registry database which was formally registered on January 5, 2026, with the Chinese Clinical Trial Registry (ChiCTR; https://www.chictr.org.cn/; registration number: ChiCTR2600116078).

Protocol version and identifier: This study protocol corresponds to Version 1.0 (dated November 1, 2025) and is identified as MBSR-GDM-2025-01. All subsequent protocol revisions will be recorded and submitted for review.

Participants and Recruitment

Pregnant women diagnosed with GDM at 24–28 gestational weeks will be screened for study eligibility at the prenatal care clinic of the study hospital. The diagnosis of GDM will be verified strictly based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria (ie, a standard 75-g oral glucose tolerance test with one or more values meeting or exceeding the following threshold: fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, or 2-h glucose ≥8.5 mmol/L).

Inclusion criteria: a singleton gestation, diagnosed with GDM between 24 and 28 weeks of gestation, age ranging from 18 to 45 years, fluent Mandarin communication ability, access to an internet-connected smartphone, and voluntary signing of written informed consent.

Exclusion criteria: pre-existing type 1 or type 2 diabetes mellitus, severe mental disorders (eg, schizophrenia, major depressive disorder) or ongoing psychiatric treatment; severe obstetric or medical complications (eg, preeclampsia, heart disease); regular mindfulness or meditation practice (no less than once weekly within the past 12 months); physical or social barriers hindering full participation in group sessions or questionnaire completion.

A research nurse will provide a detailed explanation of the study procedures to all eligible women. Written informed consent will be obtained from each participant prior to the initiation of any study-related activities.

Randomization and Blinding

Following baseline assessment, eligible participants will be randomly allocated to the MBSR intervention or the control group. The randomization sequence will be computer-generated by an independent statistician using block randomization (block sizes of 4 or 6) with a statistical software program, and the allocation concealment will be ensured via sequentially numbered, opaque, sealed envelopes.

Due to the nature of the behavioral intervention, participants and the MBSR instructor cannot be blinded to group allocation. However, outcome assessors (eg, laboratory staff and data analysts) and the research statistician will be blinded to study group allocation to minimize detection bias.

Unblinding Procedure

Given the assessor-blinded study design, allocation concealment will be strictly maintained throughout the trial. Unblinding of a participant’s treatment allocation will only be permitted in a medical emergency where the treating physician considers group information (MBSR vs health education) indispensable for determining subsequent clinical management. In such instances, the treating physician must contact the principal investigator (PI) or the designated unblinding officer. The allocation will be revealed via the pre-established, secure, centralized randomization system (or by opening the corresponding sequentially numbered, opaque, sealed envelope if an envelope system is used). The date, time, reason for unblinding, and all personnel involved will be recorded in a timely manner. Unblinded subjects will receive follow-up for primary outcome assessment whenever possible, and their data will be marked for subsequent sensitivity analyses.

Interventions Standard Care (Both Groups)

All participants will receive standard GDM care per hospital clinical protocols, which consists of individualized dietary advice from a certified nutritionist, a prescribed physical activity plan (eg, 30 minutes of moderate walking most days of the week), regular self-monitoring of blood glucose (SMBG), and pharmacological therapy (insulin or metformin) if glycemic targets are not met despite lifestyle modifications.

Intervention Group (Standard Care + MBSR Program)

Participants in the intervention group will receive an 8-week MBSR program, specifically tailored for pregnant women with GDM, in addition to standard GDM care. The program will be delivered as group sessions (8–12 participants per group) by a certified MBSR instructor specializing in perinatal care and mindfulness-based interventions. The intervention arranges a 2.5-hour weekly session for eight consecutive weeks, with an additional 4-hour silent retreat session scheduled between weeks 6 and 7. Core components of the program include formal practices (body scan meditation, sitting meditation, and pregnancy-adapted mindful yoga), informal practices focusing on incorporating mindfulness into daily routines—with a specific focus on mindful eating to facilitate dietary control—and structured group discussions focused on stress management, coping with GDM-related concerns, and integrating mindfulness into self-care routines. Additionally, participants will be expected to complete daily home practice, requiring daily 45 minutes mindfulness practice for six days per week using study-provided audio guides.

Adherence to home practice will be monitored using weekly home practice logs, which participants will submit via encrypted research communication platform. Attendance status will be recorded by the group instructors for both MBSR and health education sessions.

Control Group (Standard Care + Attention Control)

To account for the non-specific effects of group interaction and attention, participants in the control group will attend 8 weekly group sessions of the same duration. Sessions adopt lecture-based form accompanied by themed group discussions on the weekly health topic (eg, sharing birth plan preferences, discussing infant care concerns) to mirror the group interaction format of the MBSR intervention. The content will focus on general prenatal and postpartum health education (eg, childbirth preparation, infant feeding, neonatal care) and will not include any mindfulness-related or psychological stress coping strategies. The detailed weekly session content for both groups is presented in Table 1.

Table 1 Weekly Session Content for MBSR Group and Control Group

Criteria for Discontinuation or Modification of the Intervention

Participant intervention participation (MBSR sessions or health education) shall be terminated in the following circumstances: (1) occurrence of a serious adverse event presumably associated with trial interventions; (2) development of a severe obstetric complication (eg, preeclampsia, preterm labor) necessitating hospital admission or substantial modification of medical care; (3) significant deterioration in glycemic control necessitating immediate and intensive medical management as determined by the treating physician; (4) voluntary withdrawal proposed by participant from the intervention. In all such cases, the reason for discontinuation will be promptly and fully documented. Participants who discontinue the group sessions will be advised to continue with standard GDM care and where feasible, these participants may still be invited to finish follow-up outcome evaluation based on the intention-to-treat principle (ITT).

Outcome Measures

This randomized controlled trial adopts a multi-dimensional assessment method to examine the effects of MBSR among women with GDM. The primary outcome is the absolute change in glycated hemoglobin (HbA1c) level from baseline (T0, 24–28 weeks) to post-intervention assessment (T1, 36–37 weeks of gestation). HbA1c represents average glycemia within 8 to 12 weeks. Measuring HbA1c at 36–37 weeks of gestation primarily captures glycemic control during the critical intervention period (weeks 28–36), aligning with the peak insulin resistance stage during late pregnancy. Although pregnancy can be associated with increased red cell turnover rate, which may theoretically lower HbA1c, studies have confirmed that HbA1c remains a reliable clinical glycemic biomarker in the second and third trimesters when used serially to monitor trends within the same individual, as planned in this trial.

Secondary glycemic outcomes, derived from self-monitoring of blood glucose records, include Time in Range (TIR: 3.5–7.8 mmol/L), Time Below Range (TBR), and the Coefficient of Variation (CV%) which are used to assess real-time glycemic regulation and fluctuation. The target range of 3.5–7.8 mmol/L for TIR is adopted from the consensus recommendations for Continuous Glucose Monitoring (CGM) use in pregnancy by the International Diabetes in Pregnancy Study Group (IDPSG) and other contemporary guidelines, which aim to balance maternal hyperglycemia, fetal macrosomia and neonatal hypoglycemia risks. Insulin therapy utilization will also be documented as a secondary glycemic outcome. Psychological outcomes (anxiety via GAD-7, depression via EPDS, mindfulness via FFMQ, diabetes distress via PAID) and behavioral outcomes (self-management via SDSCA, dietary intake) are assessed pre- and post-intervention. Finally, obstetrical and neonatal outcomes (eg, gestational weight gain, mode of delivery, birth weight, macrosomia, NICU admission) will be retrieved from medical records at the postpartum follow-up period. Table 2 summarizes the schedule of outcome assessments across the three time points (baseline T0, post-intervention T1, and postpartum T2).

Table 2 Schedule of Outcome Assessments

Sample Size Calculation

The sample size is determined based on the primary outcome, HbA1c level. Assuming a mean between-group difference of 0.5% in HbA1c change between groups, a pooled standard deviation of 0.9%, a statistical power of 80%, and a two-sided alpha level of 0.05, a minimum of 52 participants per group is required to detect this difference. Considering a predicted 20% participant dropout rate, we plan to recruit at least a total of 130 participants (65 per group).

However, to enhance the study’s statistical power for detecting smaller, yet clinically meaningful, effects across multiple secondary outcomes (including psychological measures, glycemic variability, and maternal-neonatal endpoints), and to support robust subgroup and mediation analyses, the trial steering committee decided to increase the total sample size to 300 participants (150 per group). This expanded sample size provides ≥90% power to detect a between-group difference of 0.35% in HbA1c change (SD = 0.9%), while also covering a conservative participant dropout proportion up to 25%.

This trial will be conducted as a single-center study. The increased sample size was determined to be feasible based on the large patient admission scale of the research hospital (Fujian Maternity and Child Health Hospital) and the structured, group-based nature of the intervention, which allows for efficient recruitment and delivery.

Strategies for Retention and Follow-Up

Multiple strategies will be implemented to improve participant retention and ensure full follow-up completion: (1) Flexible session arrangement: Group sessions will be offered at multiple time slots, and make-up sessions will be provided for any missed sessions. (2) Regular contact: Research staff will maintain regular, supportive contact with participants via secure study messaging platform or phone calls between sessions to address logistical barriers and reinforce their engagement. (3) Reminder system: Automated reminders for assessments and sessions will be sent via short message service (SMS) or the hospital’s patient portal. (4) Transportation support: A modest transportation subsidy will be provided for each attended session to reduce participants’ participation burden. (5) Postpartum follow-up facilitation: The postpartum assessment (T2) will be scheduled to align with regular 6-week postnatal check-up at the same hospital to maximize convenience and improve follow-up compliance.

For participants who discontinue the group interventions but have no overall withdrawal willingness, all efforts will be made to continue collecting key outcome data including HbA1c levels at T1, and primary obstetric and neonatal outcomes from medical records at T2). Their data will be included in the primary intention-to-treat (ITT) analysis.

Data Collection and Statistical Analysis

Data will be collected via an electronic data capture system and analyzed using SPSS (version 25.0, IBM Corp) on an intention-to-treat basis. Baseline characteristics will be analyzed using t-tests, Mann–Whitney U, or chi-square tests as appropriate. For continuous outcomes (eg, HbA1c), linear mixed models will be used taking time, grouping, and interactive effect as fixed factors, adjusting for baseline values. Binary outcomes (eg, insulin therapy utilization, cesarean section) will be analyzed using generalized estimating equations (GEE) with a logit link function, an exchangeable correlation structure, and robust standard errors to account for repeated measures, or using chi-square tests for cross-sectional comparison at individual time node. A per-protocol analysis will also be performed. Statistical significance is defined as two-sided p < 0.05.

Data and Safety Monitoring

An independent Data and Safety Monitoring Board (DSMB) will be established to oversee trial progress and participant safety status. The DSMB will conduct regular reviews of pooled unblinded, aggregated safety data, including all documented and classified adverse events; all such adverse events will be formally reported to the DSMB and the ethics committee on a regular basis.

Interim Analyses and Stopping Guidelines

Given the low-risk, behavioral intervention property, no formal interim analyses for efficacy or futility are planned. The primary analysis will be conducted after all post-intervention data have been collected. However, the DSMB is empowered to recommend early termination of the trial to the Principal Investigator (PI) if: (1) unequivocal evidence emerges that the intervention causes significant harm to participants, or (2) critical feasibility issues (eg, severe participant retention deficiency) compromise the integrity of the trial.

Interim safety results will be accessible only to the DSMB. The research team, including outcome assessors and statisticians, will remain blinded to all outcome data until the trial database is formally locked. The final decision regarding trial termination rests with the Principal Investigator, following consultation with the DSMB, the institutional sponsor, and Ethics Committee.

Patient and Public Involvement

No patients or members of the public were directly involved in the initial design of the trial, development of the intervention, or planning of outcome measures for this trial. The study protocol was designed based on a systematic review of published clinical evidence and identified research gaps in the literature. However, the experiences and needs of women with gestational diabetes mellitus (GDM) were indirectly incorporated through this literature review and the clinical expertise of the research team. Plans for disseminating the trial results to participants, as outlined in the Dissemination Plan, reflect our commitment to involving the public in the reporting phase.

Trial Oversight

This single-center, investigator-initiated trial adopts an integrated supervision structure. The Principal Investigator (PI, Prof. Jianying Yan) bears full responsibility for trial design, implementation and publication. Operational oversight is delegated to a Trial Management Group (TMG), comprising the PI and co-investigators, which meets regularly to monitor progress, ensure protocol compliance, and address logistical issues.

A dedicated Data Management Team (DMT), composed of trained research staff oversees all data-related activities, including the design and maintenance of the electronic case report forms (eCRFs), data entry, validation, quality control, and secure storage. An independent Data and Safety Monitoring Board (DSMB), as detailed in Section 2.9, provides external oversight of participant safety and trial integrity.

The establishment of a formal Endpoint Adjudication Committee was deemed unnecessary, as the primary outcome (change in HbA1c levels) and key secondary outcomes are derived from objective laboratory assays and validated psychometric scales, reducing the reliance on subjective clinical assessment.

All teams and committees work under the final authority of the PI to ensure the trial is conducted in accordance with the approved protocol, ethical principles, and Good Clinical Practice (GCP) guidelines.

Trial Conduct Monitoring

As a single-center, investigator-initiated trial, formal external monitoring is not required. Trial conduct oversight is integrated into internal quality management processes led by the Principal Investigator (PI) and the Trial Management Group (TMG).

The TMG will conduct quarterly assessment on key performance indicators (recruitment progress, protocol adherence, data completeness) through structured audits. Continuous, informal oversight will occur during regular team meetings. Monitoring procedures will focus on: (1) verification of informed consent documentation and protocol compliance; (2) source data inspection to guarantee accuracy and integrity; (3) proper documentation of protocol deviations and adverse events; and (4) secure maintenance of essential study documents.

The Data Management Team will implement routine electronic data validation checks. All monitoring findings will be formally reported to the PI who will initiate prompt rectification measures to ensure ongoing protocol compliance and data integrity.

Additional Consent for Ancillary Studies

The current trial does not involve the collection or long-term storage of biological specimens for future research purposes. The informed consent form for this study specifically requests participants’ permission for the collection and analysis of data related to the primary and secondary outcomes outlined in this protocol. It contains no provisions permitting the use of participant data in unrelated future ancillary studies (ie research projects distinct from the current trial’s primary objectives). Should the research team intend to conduct ancillary studies using the collected trial data in the future, a separate ethics application will be submitted to Ethics Committee and additional written informed consent will be obtained from participants if required, prior to initiating any such ancillary research.

Protocol Amendment Communication

All substantial protocol amendments (eg, changes to eligibility criteria, study interventions, or outcome measures) require prior written approval from the Ethics Committee of Fujian Maternity and Child Health Hospital (FMCHH EC) Approved amendments will be communicated as follows:

Research Team: Via updated protocol documents and mandatory protocol training to ensure all team members understand the amended content.

Current Participants: Informed directly by study staff. Re-consent will be acquired if amendments affect study procedures or potential risks, or benefits to participants.

Trial Registry: The record in the Chinese Clinical Trial Registry (ChiCTR) record will be timely updated after amendment approval.

DSMB: Formally notified in writing of relevant amendments and their potential impacts on participant safety or trial integrity.

Minor administrative updates (eg, typographical corrections, updates to study staff contact information) that do not affect protocol compliance or participant safety will be documented internally without formal submission.

Compensation for Harm and Post-Trial Care

This study involves behavioral interventions (MBSR and health education) that are considered minimal risk and consistent with standard care for gestational diabetes mellitus (GDM). All participants will receive standard GDM care throughout the study period. In the unlikely event that a participant sustains research-related harm attributable to trial procedures, necessary medical treatment will be provided and covered by the study sponsor in accordance with the relevant regulations and the insurance policy obtained for this trial. The compensation plan has been reviewed and approved by the Ethics Committee of Fujian Maternity and Child Health Hospital. Participants will be informed of the compensation and their rights if study-related harm occurs.

Dissemination Plan

Regardless of the outcome, the trial results will be disseminated through multiple channels to maximize research transparency and public accessibility. The primary findings will be submitted for publication in a peer-reviewed, open-access journal. A summary of the results will also be reported in the Chinese Clinical Trial Registry (ChiCTR). To directly inform participants and the public, a plain-language summary will be developed and distributed to all participants and made available through the hospital’s public education channels. The results will be presented at relevant scientific conferences to engage healthcare professionals. Authorship will be in strict accordance with the ICMJE guidelines.

Discussion Theoretical and Practical Implications of Expected Findings

If the study hypotheses are confirmed, it would suggest that the intervention group may demonstrate a significantly greater reduction in HbA1c levels compared to the control group. Such a finding would carry substantial theoretical and practical implications. It would validate a definite psychophysiological mechanism through which MBSR may exert its beneficial effects in GDM: (1) From Mind to Body: By reducing perceived stress and improving emotional regulation, MBSR is likely to mitigate hypothalamic-pituitary-adrenal (HPA) axis functional disorder and restore autonomic nervous system balance, thereby lowering stress hormones such as cortisol—a key mediator of insulin resistance, as evidenced in type 2 diabetes.19 (2) Bridging with Behavior: The heightened self-awareness fostered through mindfulness practice may translate into measurable behavioral modifications, such as improved adherence to dietary recommendations via mindful eating, better sleep hygiene, and increased engagement in physical activity.17 (3) Achieving Clinical Endpoints: The synergistic effect of these psychological and behavioral adjustments is hypothesized to converge on improved glycemic control, reflected in lower HbA1c, reduced glycemic variability, and potentially a decreased need for pharmacological interventions like insulin.

While this trial is not designed as a formal mediation analysis, exploratory analyses using structural equation modeling will be conducted to assess the potential mediating roles of changes in perceived stress (as measured by the Perceived Stress Scale) and self-management behaviors (as measured by the SDSCA) on the primary outcome of glycemic control.

Clinically, these findings would be consistent with and reinforce current clinical practice guidelines for diabetes management that emphasize “patient-centered care” and “psychosocial support” as integral components. By providing an evidence-based, structured psychological intervention, this study offers a tangible operational framework to address these guideline mandates in the GDM population.

Furthermore, to enhance clinical transformation value, exploratory subgroup analyses (eg, stratification by baseline HbA1c, anxiety severity, or pre-pregnancy BMI) could be conducted to identify which GDM patient subgroups obtain optimal therapeutical effects from MBSR. This would facilitate the development of more personalized, targeted intervention approaches in the future.

From a clinical practice perspective, current standard GDM management primarily focuses on medical nutrition therapy, glucose monitoring, and indicated pharmacological interventions, with little emphasis placed on psychological health status. If this study confirms that MBSR can effectively improve glycemic control, it will provide clinicians with a feasible, non-pharmacological adjunctive intervention option. Particularly considering that many GDM patients have concerns about or psychological resistance to insulin and other medications, MBSR, as a safe and well-tolerated psychological intervention, could potentially improve patients’ treatment adherence and overall treatment satisfaction.

Comparison with Existing Literature

The design and anticipated findings of this study extend and strengthen current evidence. Previous research, such as that by Zeinabeh et al (2023), has demonstrated preliminary beneficial effects of mindfulness-based interventions on glucose control and stress reduction in women with GDM.18 However, existing evidence is substantially constrained by methodological flaws, as illustrated by the only published RCT focusing on MBSR in GDM to date, which included only 60 participants and lacked an active control group (see Introduction for details).18 Through its methodologically rigorous, large-scale randomized controlled trial (RCT) design with rigorous active control group design and prolonged postpartum follow-up, the present study will provide more rigorous, high-quality clinical evidence regarding the efficacy of MBSR as an adjunctive therapy in GDM management. A unique and innovative aspect of our study protocol is tailored GDM-specific mindful eating module, which directly addresses a key behavioral barrier in GDM management. Although systematic reviews have shown that mindful eating can improve dietary behaviors in individuals with diabetes,20 its targeted efficacy in GDM populations remains understudied, a gap our study seeks to address. Furthermore, by comprehensively assessing psychological, behavioral, and advanced glycemic metrics (eg, Time in Range, glycemic variability), our study aligns with increasing emphasis on mechanistic investigation in mindfulness research. Although we do not directly measure biomarkers such as inflammatory markers, heart rate variability or epigenetic state,21–23 our multidimensional data will help clarify behavioral and glycemic regulatory pathways through which MBSR may confer benefits, thereby complementing ongoing biological mechanistic research.

Innovations and Limitations of the Study

This trial has several methodological and clinical innovations. First, to our knowledge, this will be one of the first large-scale RCTs of MBSR in women with GDM, with a planned sample size of 300, which provides sufficient statistical power to identify clinically meaningful differences. Second, the rigorous study design, incorporating assessor blinding, intention-to-treat analysis, and long-term follow-up, enhances the validity and reliability of the findings. Third, the intervention protocol is specifically tailored to GDM-specific clinical features, increasing its relevance to the target population. Finally, the study adopts a multidimensional outcome evaluation system, assessing not only the primary endpoint of glycemic control but also psychosocial benefits and pregnancy outcomes.

Several limitations should be considered when interpreting the anticipated findings of this study. First, due to the nature of the behavioral intervention, participants and instructor blinding are unachievable, which may lead to expectation bias and potential performance bias. This limitation has been partially mitigated via the use of an active control group (receiving equal-duration health education) and assessor blinding. Second, the intervention requires considerable time investment from participants (an 8-week course plus daily home practice), which may affect recruitment and retention rates especially among patients with limited time or low acceptance of psychological intervention strategies. Third, this is a single-center study, which may limit external generalizability of the findings to broader GDM populations. Future research should validate these findings in multicenter studies involving diverse populations.

Clinical Implications and Future Research Directions

If the study hypotheses are confirmed, MBSR could be integrated into the standard clinical care pathway for GDM as a valuable adjunctive intervention to medical management. Healthcare institutions could deliver it through prenatal care classes, specialist clinics, or digital platforms to improve public accessibility and clinical applicability. Training obstetric healthcare providers in basic mindfulness- based coping techniques could further facilitate the implementation of a holistic mind-body integrated care model.

To advance this research field, future research should pursue several key directions, including mechanistic studies exploring underlying biological pathways (eg, cortisol rhythms, inflammatory markers, autonomic function) through which MBSR exerts its effects on glycemic control; implementation science research to evaluate the cost-effectiveness and feasibility of various delivery modalities (eg, online vs in-person); personalized medicine approaches to identify individual predictive factors for intervention response (eg, baseline stress, mindfulness disposition); and longitudinal follow-up studies to assess the long-term sustained therapeutic effects of MBSR on postpartum metabolic health and psychological well-being outcomes.

Conclusion

In summary, this rigorous large-scale RCT protocol details a comprehensive intervention that is designed to comprehensively evaluate the multidimensional benefits of MBSR in GDM holistic management. The findings from this future trial will provide important evidence to enrich the theoretical basis of mindfulness interventions in metabolic disorders during pregnancy and may facilitate the development of an integrated mind-body approach to GDM management. Regardless of the final trial results, this research will enrich the current evidence base of multimodal GDM interventions, offering new perspectives and options for improving maternal and fetal health outcomes.

Abbreviations

GDM, Gestational diabetes mellitus; MBSR, Mindfulness-Based Stress reduction; RCT, randomized controlled trial; HbA1c, glycated hemoglobin; TIR, Time in Range; TBR, Time Below Range; CV, coefficient of variation; MNT, medical nutrition therapy; HPA, hypothalamic-pituitary-adrenal.

Data Sharing Statement

The datasets generated or analyzed during the current study are not publicly available due to participant confidentiality and data privacy restrictions but are available from the corresponding author (Jianying Yan) upon reasonable scientific request, subject to approval from the institutional ethics committee. The data will be anonymized, and no patient information will be included to preserve confidentiality.

Ethics Approval and Informed Consent

This human study was approved by Fujian Maternity and Child Health Hospital Ethics Committee. The studies will be conducted in accordance with the local legislation and institutional requirements. This study will be conducted in accordance with the principles of the Declaration of Helsinki. The participants will provide written informed consent to participate in this study.

Author Contributions

Xiaoyan Xiu: Conceptualization, Writing –original draft, Writing – review & editing; Yingying Lin: Data curation, Formal analysis, Methodology, Writing – review & editing; Jiaying Lin: Data curation, Formal analysis, Writing – review & editing; Yi Chen: Methodology, Writing – review & editing; Ruimin Zheng: Visualization, Writing – review & editing; Jianying Yan: Data curation, Writing – review & editing, Supervision. All authors have provided final approval of the published version; have agreed on the journal to which the article has been submitted; and agreed to take accountability for all aspects of the work.

Funding

This work was supported by Joint Funds for the Innovation of Science and Technology, Fujian province (2025Y9618) and the Fujian provincial health technology project (2025CXB030). This trial is sponsored by Fujian Maternity and Child Health Hospital. The sponsors and funders (Joint Funds for the Innovation of Science and Technology, Fujian province [2025Y9618] and the Fujian provincial health technology project [2025CXB030]) had no role in study design, data collection, analysis, article drafting or publication decisions. Principal Investigator (Prof. Jianying Yan) and the research team hold complete scientific and operational authority over the entire trial, including study design, data collection, management, analysis, and the decision to publish.

Disclosure

The authors declare no potential financial or non-financial conflict of interest.

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