Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 9, 2025
Date Accepted: Jun 3, 2025
Effects of Cognitive Behavioral Therapy for Diet on Postprandial Glucose and Pregnancy Outcomes in Gestational Diabetes Mellitus: A multicenter randomized controlled trial
ABSTRACT
Background:
Gestational diabetes mellitus (GDM) may increase the risk of serious complications in pregnancy. Dietary management is vital in the management of GDM on account of its beneficial effects on metabolic control. However, low adherence to dietary management has limited the benefits of blood glucose levels. Cognitive behavioral therapy (CBT) based interventions have been proposed as a promising solution for patients with GDM.
Objective:
To investigate the effects of CBT-based digitalized dietary intervention on glycemic control and pregnancy outcomes in patients with GDM.
Methods:
A 12-week multicenter randomized controlled trial was conducted in pregnant women with GDM. 200 GDM patients were randomized 1:1 to intervention or control. The intervention group received standardized care and digitalized dietary intervention based on CBT, while the control group received standardized care only. The intervention group received the customized developed dietary courses based on the CBT methodology via WeChat mini-app. Patients followed the instructions to apply the skills of proper food choice and meal sequence. Glycemic qualification rate (GQR) and glucose level were explored. Follow-up visits were conducted every two weeks (noted here as T) from enrollment to delivery. Self monitoring blood glucose (SMBG) records were used for the analysis. General self-efficacy scale (GSES), and incidence of macrosomia were also evaluated.
Results:
Among 171 patients who completed follow-up, the average age was 31.2±4 years and the average gestational age was 26.3±1.6 weeks. Baseline HbA1c was 5.2% and 5.1% in the intervention and control groups, respectively (P>.05). The GQR of the intervention group was significantly higher than that of the control group in most Ts ( T3 87.9 ± 14.9% vs 81.9 ± 17.8%, T4 91.0 ± 9.9% vs 87.2 ± 14.4 %, T5 94.0 ± 7.4% vs 91.5 ± 9.5% and T6 94.3 ± 6.7% vs 91.8 ± 8.9%, all P<.05). The values of postprandial blood glucose (PBG) were significantly lower in the intervention group than that in the control group (1h after lunch: 5.9 ± 0.7 vs 6.0 ± 0.7,2h after lunch: 5.1 ± 0.7 vs 5.3 ± 0.8 mmol/L, 1h after dinner: 6.0 ± 0.5 vs 6.2 ± 0.6, 2h after dinner: 5.5 ± 0.7 vs 5.7 ± 0.8 mmol/L, all P<.05). However, there were no significant differences in FBG and PBG after breakfast between the two groups. GSES was significantly higher in the intervention group than that in the control group (195.4 ± 6.9 vs 192.9 ± 5.8 , P<.01). There was less macrosomia in the intervention group than in the control group (5% vs 15%, P=.04). Antidiabetic drugs were not used in two groups during the follow-up of this study.
Conclusions:
Our data suggested that CBT-based digital dietary intervention could increase glycemic qualification rate, decrease postprandial glucose and further improve pregnancy outcome in patients with GDM. Clinical Trial: Chinese Clinical Trial Registry (ChiCTR2100048527); https://www.chictr.org.cn/showprojEN.html?proj=129799
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