Randomized efficacy trial of early preconception counseling for diabetic teens (READY-girls). Helping other mothers effectively work at raising young children with type 1 diabetes. A nurse-coaching intervention for women with type 2 diabetes. Addressing preconception risks identified at the time of a negative pregnancy test. A randomized trial. Telecommunication support for rural women with diabetes. Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women. A randomized trial of an intervention to improve self-care behaviors of African-American women with type 2 diabetes: impact on physical activity. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. Feasibility of a lifestyle intervention in early pregnancy to prevent deterioration of glucose tolerance.
To develop and assess the feasibility of an early preconception counseling program for adolescents called READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls).
                A total of 53 adolescent females with type 1 diabetes between 16 and 19.9 years of age were randomized into groups receiving a CD-ROM, a book, or standard care (control) and given one comprehensive session. Outcomes were assessed at baseline, immediately after, and at 3 months.
                Teens who received the CD and those who received the book demonstrated significant (P < or = 0.05) sustained improvement (over 3 months) in knowledge, perceived benefits of both receiving preconception counseling and using effective family planning, and perceived more support with reproductive health issues.
                Clinical feasibility of the program was demonstrated. Both the CD and the book appeared to be efficacious formats for the short term. Future studies should examine repeated boosters of a CD and a book, which are not meant to replace but rather to reinforce and supplement health professional education. This study examined the feasibility of a postdiagnosis parent mentoring intervention for mothers of young children (1-10 years old) newly diagnosed with type 1 diabetes.
                A mixed-method, prospective, randomized, controlled clinical trial design was used. Parent mentors (experienced mothers who have successfully raised young children with type 1 diabetes) and mother participants with young children newly diagnosed with type 1 diabetes were recruited from 2 regional pediatric diabetes centers. The mentors were trained to provide informational, affirmational, and emotional support using Ireys' modified parent mentor curriculum. During a 6-month trial, mentors provided home visits and phone call support to the mothers who were randomized to the experimental group. The control group had the option of receiving the intervention after the 6-month trial.
                Mothers in the experimental group had fewer concerns, more confidence, identified more resources, and perceived diabetes having less of a negative impact on their family compared with mothers in the control group. Parent mentors provided important, practical day-to-day management information, reassurance, and emotional support during times of crises.
                A postdiagnosis parent mentoring intervention for mothers of children with diabetes appears to be feasible and potentially effective. The purpose of this pilot study was to determine the efficacy of a 6-month nurse-coaching intervention that was provided after diabetes education for women with type 2 diabetes.
                In this pilot study, 53 women were randomized to the nurse-coaching intervention or a standard care control condition. The nurse-coaching intervention consisted of 5 individualized sessions and 2 follow-up phone calls over 6 months. The nurse-coaching sessions included educational, behavioral, and affective strategies. Data were collected on physiologic adaptation (hemoglobin A1c [A1C] and body mass index [BMI]), self-management (dietary and exercise), psychosocial adaptation (diabetes-related distress and integration), and treatment satisfaction at baseline, 3 months, and 6 months.
                Women in the treatment group demonstrated better diet self-management, less diabetes-related distress, better integration, and more satisfaction with care, and had trends of better exercise self-management and BMI. The A1C levels improved in both groups at 3 months, yet the difference between the groups was not significant. Attendance at nurse-coaching sessions was 96%.
                This nurse-coaching intervention demonstrates promise as a means of improving self-management and psychosocial outcomes in women with type 2 diabetes. A preconception care program has the potential to assist women who want to become pregnant by advising these women about risk factors, healthy lifestyles, and assessing readiness for pregnancy. We conducted a randomized controlled trial to determine whether comprehensive preconception risk assessment at the time of a negative pregnancy test followed by referral to primary care services is effective in initiating treatment for women with preconception risk factors.
                One hundred seventy women were offered preconception risk assessment following a negative pregnancy test. Women were assigned randomly either to a usual care group or an intervention group. Women in the latter group were informed about the risks identified and received an appointment with a primary care clinician who was also informed. Women in the usual care group and their clinicians received no feedback. All charts were reviewed and the women were contacted by telephone to determine if interventions to reduce risk were offered by clinicians during the year following the assessment.
                An average of 8.96 risks were identified per woman. The proportion of women having risks in each of 12 risk categories studied ranged from 19% to 71%. One hundred women (59%) made at least one visit during the subsequent year, thus allowing the opportunity for preconception care. The proportion of these women who had a risk addressed ranged from 18% for psychosocial risks to 48% for those with fetal exposures (smoking, alcohol, and drug use). There was no difference between groups in the percentage of risks addressed.
                The notification of women and their clinicians of identified preconception risks did not improve intervention rates. A more organized intervention system including office-based protocols is needed. The Women to Women Diabetes Project tested the use of telecommunication technology to deliver diabetes education and social support to rural women with diabetes. The aims were to (1) test the effects of the computer intervention in providing support, information, and education on selected outcomes, and (2) evaluate the women's attitudes toward and satisfaction with the intervention and the support provided.
                Thirty women were randomized into computer and noncomputer groups and participated for 10 months. For 5 months, one group participated in a self-help support and educational group via the computer; the other group continued to use their usual modes of support and communication. Psychosocial well-being scales were administered and attitudes were surveyed.
                Improving health and higher educational levels positively influenced measures of social support and quality of life. Women who were married or who reported greater support had higher scores on the Personal Resource Questionnaire. The women expressed positive effects of the computer-based support group on their lives.
                The intervention was enthusiastically accepted, and could be conducted effectively in isolated rural areas. To compare maternal glucose levels and neonatal outcome, achieved in women with gestational diabetes (GDM) receiving either regular insulin or insulin lispro, with those of a control group of non-diabetic pregnant women.
                We enrolled 49 pregnant women with GDM, randomly allocated to the treatment with either insulin lispro (n=25) or regular insulin (n=24), and 50 pregnant women with normal GCT, matched for age, parity, pre-pregnancy weight and BMI, who formed the control group. All the women were caucasian, non-obese, with a singleton pregnancy and delivered term live born infants. Women of both groups were requested to perform a blood glucose profile (consisting of nine determinations: fasting/pre-prandial, 1 and 2h post-prandial) every week from the time of diagnosis to 38 weeks (study subgroups) or every 2 weeks from 28 to 38 weeks' gestation (control group).
                Overall pre-prandial blood glucose values in diabetic women were significantly higher than those of controls; at the 1h post-prandial time point, blood glucose values of GDM women receiving insulin lispro were similar to those of controls, whereas in the regular group they were significantly higher. Overall, both the lispro and regular insulin obtained optimal metabolic control at the 2h post-prandial time point, although near-normal blood glucose levels 2h after lunch could be observed only in the lispro group. There were no statistically significant differences between the groups in neonatal outcome and anthropometric characteristics; however, the rate of infants with a cranial-thoracic circumference (CC/CT) ratio between the 10th and the 25th percentile was significantly higher in the group treated with regular insulin in comparison to the lispro and control groups.
                Fasting/pre-prandial and 1h post-prandial maternal blood glucose levels in non-diabetic pregnant women fell well below the currently accepted criteria of glycemic normality in diabetic pregnancies. In women with GDM, the use of insulin lispro enabled the attainment of near-normal glucose levels at the 1h post-prandial time point and was associated with normal anthropometric characteristics; the use of regular insulin was not able to blunt the 1h peak post-prandial response to a near-normal extent and resulted in infants with a tendency toward the disproportionate growth. Insulin lispro can be regarded as a valuable option for the treatment of gestational diabetes. To determine whether a culturally appropriate clinic- and community-based intervention for African-American women with type 2 diabetes will increase moderate-intensity physical activity (PA).
                In this randomized controlled trial conducted at seven practices in central North Carolina, 200 African-American women, > or =40 years of age with type 2 diabetes, were randomized to one of three treatment conditions: clinic and community (group A), clinic only (group B), or minimal intervention (group C). The clinic-based intervention (groups A and B) consisted of four monthly visits with a nutritionist who provided counseling to enhance PA and dietary intake that was tailored to baseline practices and attitudes; the community-based intervention (group A) consisted of three group sessions and 12 monthly phone calls from a peer counselor and was designed to provide social support and reinforce behavior change goals; and the minimal intervention (group C) consisted of educational pamphlets mailed to participants. The primary study outcome was the comparison of PA levels between groups assessed at 6 and 12 months by accelerometer, which was worn while awake for 7 days.
                Totals of 175 (88%) and 167 (84%) participants completed PA assessment at 6 and 12 months, respectively. For comparison of PA, the P value for overall group effect was 0.014. Comparing group A with C, the difference in the average adjusted mean for PA was 44.1 kcal/day (95% CI 13.1-75.1, P = 0.0055). Comparing group B with C, the difference in the average adjusted mean was 33.1 kcal/day (95% CI 3.3-62.8, P = 0.029). The intervention was acceptable to participants: 88% were very satisfied with clinic-based counseling to enhance PA, and 86% indicated that the peer counselor's role in the program was important.
                The intervention was associated with a modest enhancement of PA and was acceptable to participants. We conducted a randomized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications.
                We randomly assigned women between 24 and 34 weeks' gestation who had gestational diabetes to receive dietary advice, blood glucose monitoring, and insulin therapy as needed (the intervention group) or routine care. Primary outcomes included serious perinatal complications (defined as death, shoulder dystocia, bone fracture, and nerve palsy), admission to the neonatal nursery, jaundice requiring phototherapy, induction of labor, cesarean birth, and maternal anxiety, depression, and health status.
                The rate of serious perinatal complications was significantly lower among the infants of the 490 women in the intervention group than among the infants of the 510 women in the routine-care group (1 percent vs. 4 percent; relative risk adjusted for maternal age, race or ethnic group, and parity, 0.33; 95 percent confidence interval, 0.14 to 0.75; P=0.01). However, more infants of women in the intervention group were admitted to the neonatal nursery (71 percent vs. 61 percent; adjusted relative risk, 1.13; 95 percent confidence interval, 1.03 to 1.23; P=0.01). Women in the intervention group had a higher rate of induction of labor than the women in the routine-care group (39 percent vs. 29 percent; adjusted relative risk, 1.36; 95 percent confidence interval, 1.15 to 1.62; P<0.001), although the rates of cesarean delivery were similar (31 percent and 32 percent, respectively; adjusted relative risk, 0.97; 95 percent confidence interval, 0.81 to 1.16; P=0.73). At three months post partum, data on the women's mood and quality of life, available for 573 women, revealed lower rates of depression and higher scores, consistent with improved health status, in the intervention group.
                Treatment of gestational diabetes reduces serious perinatal morbidity and may also improve the woman's health-related quality of life. In conjunction with the growing prevalence of obesity and the older age of pregnant women gestational diabetes (GDM) is a major health problem.The aim of the study was to evaluate if a lifestyle intervention since early pregnancy is feasible in improving the glucose tolerance of women at a high-risk for GDM in Finland.
                A 75-g oral glucose tolerance test (OGTT) was performed in early pregnancy (n = 102). Women at high risk for GDM (n = 54) were randomized at weeks 8-12 from Apr 2005 to May 2006 to a lifestyle intervention group (n = 27) or to a close follow-up group (n = 27). An OGTT was performed again at weeks 26-28 for the lifestyle intervention and close follow-up groups.
                The values of the OGTT during the second trimester did not differ between the lifestyle intervention and close follow-up groups. In the lifestyle intervention group three women had GDM in the second trimester and respectively one woman in the close follow up group. Insulin therapy was not required in both groups. The intervention resulted in somewhat lower weight gain 11.4 ± 6.0 kg vs. 13.9 ± 5.1 kg, p = 0.062, adjusted by the prepregnancy weight.
                Early intervention with an OGTT and simple lifestyle advice is feasible. A more intensive lifestyle intervention did not offer additional benefits with respect to glucose tolerance, although it tended to ameliorate the weight gain.
                ClinicalTrials.gov: NCT01130012.
Little evidence is available to recommend for or against preconception care for women with pre-existing diabetes. Further large, high-quality randomised controlled trials are needed to evaluate the effect of different protocols of preconception care for women with pre-existing diabetes.