Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.

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: · Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..

The effect of group prenatal care for women with diabetes on social support and depressive symptoms: a pilot randomized trial.

Objective: To measure the impact of group prenatal care (GPC) on diabetes-specific peer support and depressive symptoms in women with pregnancies complicated by diabetes.Materials and methods: This is a planned secondary analysis of a two-center pilot randomized controlled trial conducted at Denver health (DH) and Washington University in St. Louis (WU) including Spanish (DH) or English (WU) speaking women with type 2 or gestational diabetes. Women were randomized to diabetes GPC or individual prenatal care (IPC) in the resident diabetes clinic. Participants completed an Edinburgh Postnatal Depression Scale (EPDS) at randomization, at 38-week gestation and at 6-12 weeks postpartum. The diabetes support scale (DSS), which includes 12 questions answered on a Likert scale, was administered at 38 weeks. Analysis was by intention to treat (clincaltrials.gov#NCT02444325).Results: A total of 84 women were consented and randomized. Six withdrew consent (two from each cohort) or were lost to follow-up (two from IPC), and three did not complete the 38-week assessment (two from GPC and one from IPC), resulting in primary outcome data available for 75 women: 38 in GPC and 37 in IPC. More women randomized to GPC reported composite positive peer support on the DSS (52.5 versus 26.3%; p < .02). There were no differences in EPDS scores, depression (EPDS >10), or rates of improved EPDS score from baseline to 38 weeks.Conclusion: GPC for women with diabetes is associated with improved diabetes-specific peer social support with no significant impact on depressive symptoms.Clinical trial registration: Clincaltrials.gov NCT02444.