Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care

Abstract

Objective This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. Study Design A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. Results Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0–0.7] vs. 0.5 lbs/week [interquartile range: 0.2–0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4–8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms. Conclusion Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes. Key Points

Maternal satisfaction with group care: a systematic review

“…Finally, 18 articles, encompassing data from 20 studies, were included in evidence synthesis. 6 , 7 , 9 , 36 , 37 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51

Figure 1 Study selection process

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Implementation and evaluation of the centering pregnancy group prenatal care model in pregnant women with diabetes: a convergent parallel mixed methods study protocol

“…Education regarding GDM control, healthy eating, and physical activity are practical interventions that improve self-care and empower women with diabetes [ 54 , 55 ]. Centering Pregnancy group prenatal care model, has demonstrated encouraging outcomes in improving nutrition and lifestyle among women with diabetes [ 32 ]. However, existing studies on the Centering Pregnancy model have predominantly focused on healthy pregnant women, and there is a lack of qualitative or mixed-methods research specifically investigating its effectiveness in pregnant women with diabetes [ 48 , 56 – 58 ].…”

“…Measuring the level of satisfaction with antenatal care using the Visual Analog Scale (VAS) involves a graded line ruler that is 10 centimeters long. The woman is required to indicate her level of satisfaction on this graded line, with zero representing dissatisfaction and 10 representing the highest level of satisfaction [ 32 ].…”

Electronic Monitoring Of Mom’s Schedule (eMOMSTM): Recruitment of pregnant populations with elevated BMI in a feasibility randomized controlled trial

“…A recent pilot intervention for pregnant women with diabetes saw an unprecedented adherence rate of 93%, along with successful recruitment; authors noted that study sites had a strong, pre-established commitment to diabetes prevention that may have contributed to the program’s success ( Carter et al, 2022 ). More importantly, they concluded that buy-in of study site providers and staff were key drivers to successful recruitment outcomes.…”