ArticleDiabetes, metabolic syndrome and obesity : targets and therapy2026
Mindfulness-Based Stress Reduction as an Adjunct Therapy for Gestational Diabetes Mellitus: A Randomized Controlled Trial Protocol.
Article in Diabetes, metabolic syndrome and obesity : targets and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Gestational diabetes mellitus (GDM) is a common pregnancy complication associated with substantial maternal and fetal health risks. Apart from metabolic disturbances, a confirmed GDM diagnosis often elicits anxiety, depression, and diabetes-specific distress, which may activate the hypothalamic-pituitary-adrenal (HPA) axis, exacerbate insulin resistance, and undermine glycemic regulation, creating a psychometabolic vicious cycle. Mindfulness-Based Stress Reduction (MBSR) is an evidence-based intervention that facilitates emotional regulation and boosts stress resilience. Despite its proven benefits in type 2 diabetes, its efficacy on glycemic control and psychological well-being in GDM remains inadequately examined in rigorous trials. Methods and Analysis: In this prospective, assessor-blinded, randomized controlled trial, 300 pregnant women with GDM (24-28 weeks) will be randomly assigned (1:1) to an 8-week group-based MBSR program plus routine standard antenatal care (intervention group) or standard care plus matched gestational health education (control group). The trial will be conducted at Fujian Maternity and Child Health Hospital, Fuzhou, China. The health education covers general pregnancy health knowledge but without incorporating mindfulness or stress-management strategies, serving as an attention control. The primary outcome is the change in glycated hemoglobin (HbA1c) from baseline to the post-intervention at 36-37 gestational weeks. Secondary outcomes include continuous glucose monitoring metrics (Time in Range, Coefficient of Variation), psychological indicators (anxiety, depression, mindfulness, diabetes distress), self-management adherences, insulin usage rate, and maternal and neonatal clinical outcomes. The primary outcome will be analyzed using intention-to-treat linear mixed-effects models, with secondary outcomes analyzed via generalized estimating equations or chi-square tests as applicable. The trial will include 300 participants (150 per group), ensuring no less than 90% statistical power to detect a between-group difference of 0.35% in HbA1c variation. Additional per-protocol analysis and exploratory mediation analyses will also be conducted. Conclusion: This trial protocol presents a randomized controlled trial aiming to generate high-quality clinical evidence regarding the efficacy of MBSR in improving psychological status and optimizing glycemic regulation in GDM. The findings, once available, may facilitate its integration as a feasible adjunctive intervention within holistic GDM care.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.