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Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.
Carter, EB, Barbier, K, Hill, PK, Cahill, AG, Colditz, GA, Macones, GA, Tuuli, MG, Mazzoni, SE
American journal of perinatology. 2022;(1):45-53
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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 · 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..
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Effectiveness of carbohydrate counting and Dietary Approach to Stop Hypertension dietary intervention on managing Gestational Diabetes Mellitus among pregnant women who used metformin: A randomized controlled clinical trial.
Allehdan, S, Basha, A, Hyassat, D, Nabhan, M, Qasrawi, H, Tayyem, R
Clinical nutrition (Edinburgh, Scotland). 2022;(2):384-395
Abstract
BACKGROUND Gestational diabetes mellitus (GDM) is one of the most common complication of pregnancy that has significant impacts on both mother and her offspring health. The present study aimed to examine the effect of carbohydrate counting, carbohydrate counting combined with DASH, and control dietary interventions on glycemic control, and maternal and neonatal outcomes. METHODS A total of 75 pregnant women with GDM at 24th - 30th week of gestation were enrolled and randomized to follow one of the three diets: control or carbohydrate counting, or carbohydrate counting combined with Dietary Approach to Stop Hypertension (DASH). Only 70 of them completed the study until delivery. Fasting blood samples were taken at baseline and the end of the study to measure fasting blood glucose (FBG), fasting insulin, glycated hemoglobin (HbA1c), and fructosamine. Homeostatic model assessment-insulin resistance (HOMA-IR) score was calculated using HOMA2 calculator program. The participants recorded at least four blood glucose readings per day. Maternal and neonatal outcomes were collected from medical records. Dietary intake was assessed by three-day food records at the baseline and the end of the study. RESULTS Adherence to the three dietary interventions, resulted in decreased FBG levels significantly among all the participants (P < 0.05). Consumption of the carbohydrate counting combined with the DASH diet showed significant reduction in serum insulin levels and HOMA-IR score compared to carbohydrate counting group and control group. Means of fructosamine and HbA1c did not differ significantly among the three intervention diet groups. Overall mean of 1-h postprandial glucose (1 h PG) level was significantly lower in the carbohydrate counting combined with DASH group compared with that in the carbohydrate counting group and the control group (P < 0.001). The number of women who were required to commence insulin therapy after dietary intervention was significantly lower in carbohydrate counting group and carbohydrate counting combined with DASH group (P = 0.026). There were no significant differences in other maternal and neonatal outcomes among the three dietary intervention groups. CONCLUSIONS The carbohydrate counting and the carbohydrate counting combined with DASH dietary interventions resulted in beneficial effects on FBG and 1 h PG compared with the control diet. The three dietary interventions produced similar maternal and neonatal outcomes in women with GDM. TRIAL REGISTRATION This trial was registered on ClinicalTrials.gov under the identification code: NCT03244579. https://clinicaltrials.gov/ct2/show/NCT03244579.
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Effects of a Prenatal Lifestyle Intervention in Routine Care on Maternal Health Behaviour in the First Year Postpartum-Secondary Findings of the Cluster-Randomised GeliS Trial.
Geyer, K, Spies, M, Günther, J, Hoffmann, J, Raab, R, Meyer, D, Rauh, K, Hauner, H
Nutrients. 2021;(4)
Abstract
Lifestyle interventions during pregnancy were shown to beneficially influence maternal dietary behaviour and physical activity, but their effect on health behaviour after delivery is unclear. The objective of this secondary analysis was to investigate the sustained effect of a lifestyle intervention in routine care on maternal health behaviour during the first year postpartum. The cluster-randomised controlled "Healthy living in pregnancy" (GeliS) study included 2286 pregnant women. Data on maternal health behaviour were collected at 6-8 weeks (T1pp) and one year postpartum (T2pp) using validated questionnaires. The intervention group showed a lower mean intake of fast food (T1pp: p = 0.016; T2pp: p < 0.001) and soft drinks (T1pp: p < 0.001), a higher mean intake of vegetables (T2pp: p = 0.015) and was more likely to use healthy oils for meal preparation than the control group. Dietary quality rated by a healthy eating index was higher in the intervention group (T1pp: p = 0.093; T2pp: p = 0.043). There were minor trends towards an intervention effect on physical activity behaviour. The proportion of smokers was lower in the intervention group (p < 0.001, both time points). The lifestyle intervention within routine care modestly improved maternal postpartum dietary and smoking behaviours.
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Infant growth during the first year of life following a pregnancy lifestyle intervention in routine care-Findings from the cluster-randomised GeliS trial.
Hoffmann, J, Günther, J, Stecher, L, Spies, M, Geyer, K, Raab, R, Meyer, D, Rauh, K, Hauner, H
Pediatric obesity. 2021;(2):e12705
Abstract
BACKGROUND Lifestyle interventions in pregnancy may influence postpartum development and obesity risk in offspring. The impact of lifestyle interventions as health system-based approaches is unclear. OBJECTIVE To evaluate the effect of an antenatal lifestyle intervention conducted as public health approach on infant development and feeding practices. METHODS We followed offspring born to women participating in the cluster-randomised GeliS trial who received usual care (CG) or repeated lifestyle counselling (IG). We collected data on offspring development and complementary feeding until the 12th month postpartum. RESULTS Of the 1998 mother-child pairs, 1783 completed the follow-up. Mean infant weight at 12 months was comparable between groups (IG: 9497.9 ± 1137.0 g; CG: 9433.4 ± 1055.2 g; P = .177). There was no significant evidence of differences in sex- and age-adjusted z-scores or in the odds of offspring being overweight. More infants in the IG received whole-grain products compared to the CG (95.6% vs. 90.8%; P = .003). Despite small differences in the timing of introducing solid foods, there were no further significant differences in the pattern of complementary feeding. CONCLUSIONS The antenatal lifestyle intervention embedded in routine care did not substantially influence infant anthropometrics and is thus unlikely to impact future development.
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Effect of an Antenatal Lifestyle Intervention on Dietary Inflammatory Index and Its Associations with Maternal and Fetal Outcomes: A Secondary Analysis of the PEARS Trial.
Killeen, SL, Phillips, CM, Delahunt, A, Yelverton, CA, Shivappa, N, Hébert, JR, Kennelly, MA, Cronin, M, Mehegan, J, McAuliffe, FM
Nutrients. 2021;(8)
Abstract
We investigated the effect of an antenatal lifestyle intervention of a low-glycaemic index (GI) diet and physical activity on energy-adjusted dietary inflammatory index (E-DIITM) and explored its relationship with maternal and child health in women with overweight and obesity. This was a secondary analysis of 434 mother-child pairs from the Pregnancy Exercise and Nutrition Study (PEARS) trial in Dublin, Ireland. E-DIITM scores were calculated for early (10-16 weeks) and late (28 weeks) pregnancy. Outcomes included lipids, inflammation markers, insulin resistance, mode of delivery, infant size, pre-eclampsia, and gestational diabetes. T-tests were used to assess changes in E-DIITM. Chi-square, correlations, and multiple regression were employed to investigate relationships with outcomes. The mean (SD) age of participants was 32.45 (4.29) years with median (IQR) BMI 28.25 (26.70, 31.34) kg/m2. There was no change in E-DIITM in the controls (-0.14 (1.19) vs. -0.07 (1.09), p = 0.465) but E-DIITM reduced by 10% after the intervention (0.01 (1.07) vs -0.75 (1.05), p < 0.001). No associations were found between early pregnancy E-DIITM and maternal and child outcomes, except for increased odds of adverse cardiometabolic phenotype in women who delivered male (OR = 2.29, p = 0.010) but not female infants (OR = 0.99, p = 0.960). A low-GI antenatal intervention can reduce the inflammatory potential of diets. Sex differences should be explored further in future research.
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A randomized controlled trial of daily weighing in pregnancy to control gestational weight gain.
Arthur, C, Di Corleto, E, Ballard, E, Kothari, A
BMC pregnancy and childbirth. 2020;(1):223
Abstract
BACKGROUND Excessive gestational weight gain is a modifiable risk factor for the development of obstetric and neonatal complications, and can have a lifelong impact on the health of both mother and offspring. The purpose of this study was to assess whether in addition to standardized medical advice regarding weight gain in pregnancy (including adherence to the Institute of Medicine (IOM) guidelines) (IOM (Institute of Medicine) and NRC (National Research Council, Weight Gain During Pregnancy: Re-examining the guidelines, 2009)), the addition of daily weighing would provide a low cost and simple intervention to reduce excessive weight gain in pregnancy by maintaining weight gain within the target range. METHODS Women presenting for antenatal care to a secondary level hospital were randomised to routine care or daily weight monitoring. Both groups received nutrition and exercise advice. RESULTS Three hundred and ninety-six women were randomised to either the daily weight monitoring group or control group with complete data available for 326 women. The percentage weight gain above target (86.9% (SD 52.3) v 92.7% (SD 50.8) p = 0.31) and change in weight per week during the study period (0.59 kg (SD 0.30) v 0.63 kg (SD 0.31) p = 0.22) were lesser in those undergoing daily weighing compared to routine management, however these did not reach statistical significance. CONCLUSION Daily weight monitoring as a stand-alone intervention has potential to reduce excessive gestational weight gain. It may have a role as a part of a larger intervention involving dietary and exercise modifications. TRIAL REGISTRATION The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry. (ACTRN12613001165774, 23/10/ 2013).
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A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.
Ferrara, A, Hedderson, MM, Brown, SD, Ehrlich, SF, Tsai, AL, Feng, J, Galarce, M, Marcovina, S, Catalano, P, Quesenberry, CP
The lancet. Diabetes & endocrinology. 2020;(6):490-500
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BACKGROUND Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity. METHODS We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m2, and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232. FINDINGS Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed. INTERPRETATION Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions. FUNDING US National Institutes of Health.
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Effects of prenatal individualized mixed management on breastfeeding and maternal health at three days postpartum: A randomized controlled trial.
Zhao, Y, Lin, Q, Wang, J, Bao, J
Early human development. 2020;:104944
Abstract
BACKGROUND Pregnant women with antenatal depression are more prone to postpartum depression and failure in breastfeeding than women without antenatal depression. The purpose of this study was to evaluate the effectiveness of a prenatal individualized mixed management intervention on breastfeeding and maternal physical and psychological status at three days postpartum. METHODS This randomized single-blind controlled trial was conducted from December 2017 to August 2018 with 182 primiparous women in Shanghai, China. Participants with Edinburgh Postnatal Depression Scale (EPDS) scores ≥9 were randomly allocated to the intervention group (n = 91) or control group (n = 91). The intervention group underwent a 4-session individualized mixed management intervention and the control group received usual care. Feeding patterns, Breastfeeding Self-Efficacy Scale (BSES), Infant Breastfeeding Assessment Scale (IBAS), and EPDS were used to measure the main outcomes. Two-tailed p-values of p < .05 were considered statistically significant. RESULTS The intervention group had significantly more effective breastfeeding behavior, better breastfeeding self-efficacy, more successful breastfeeding initiation, lower EPDS scores, more sleep time, and better appetite than the control group. CONCLUSION The prenatal individualized mixed management intervention demonstrated significant short-term improvement in breastfeeding and maternal physical and psychological health at three days postpartum. TRIAL REGISTRATION ChiCTR-IOR-17013761; December 7, 2017.
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Effect of metformin in addition to an antenatal diet and lifestyle intervention on fetal growth and adiposity: the GRoW randomised trial.
Poprzeczny, AJ, Louise, J, Deussen, AR, Dodd, JM
BMC endocrine disorders. 2020;(1):139
Abstract
BACKGROUND The infants born to women who are overweight or obese in pregnancy are at an increased risk of being born macrosomic or large for gestational age. Antenatal dietary and lifestyle interventions have been shown to be ineffective at reducing this risk. Our aim was to examine the effects of metformin in addition to a diet and lifestyle intervention on fetal growth and adiposity among women with a BMI above the healthy range. METHODS Women who had a body mass index ≥25 kg/m2 in early pregnancy, and a singleton gestation, were enrolled in the GRoW trial from three public maternity hospitals in metropolitan Adelaide. Women were invited to have a research ultrasounds at 28 and 36 weeks' gestation at which ultrasound measures of fetal biometry and adiposity were obtained. Fetal biometry z-scores and trajectories were calculated. Measurements and calculations were compared between treatment groups. This secondary analysis was pre-specified. RESULTS Ultrasound data from 511 women were included in this analysis. The difference in femur length at 36 weeks' gestation was (0.07 cm, 95% CI 0.01-0.14 cm, p = 0.019) and this was was statistically significant, however the magnitude of effect was small. Differences between treatment groups for all other fetal biometry measures, z-scores, estimated fetal weight, and adiposity measures at 28 and 36 weeks' gestation were similar. CONCLUSIONS The addition of metformin to dietary and lifestyle advice in pregnancy for overweight and obese women has no clinically relevant effect on ultrasound measures of fetal biometry or adiposity. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry ( ACTRN12612001277831 ).
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How can we best use opportunities provided by routine maternity care to engage women in improving their diets and health?
Lawrence, W, Vogel, C, Strömmer, S, Morris, T, Treadgold, B, Watson, D, Hart, K, McGill, K, Hammond, J, Harvey, NC, et al
Maternal & child nutrition. 2020;(1):e12900
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Pregnancy provides motivation for women to improve their diets and increase their physical activity. Opportunistic brief interventions delivered as part of routine primary care have produced improvements in patients' health behaviour. Consequently, there have been calls for midwives to use contacts during pregnancy in this way. This study explored the experiences of pregnant women and research midwives/nurses of a brief intervention called Healthy Conversation Skills (HCS) being delivered as part of a randomised control trial, assessing the acceptability and feasibility of including this intervention in routine maternity care. Three research questions were addressed using mixed methods to produce four datasets: face-to-face interviews with participants, a focus group with the HCS-trained midwives/nurses, case reports of participants receiving HCS and audio-recordings of mid-pregnancy telephone calls to the women which produced midwife/nurse HCS competency scores. Midwives/nurses used their HCS to support women to make plans for change and set goals. Women welcomed the opportunity to address their own health and well-being as distinct from that of their baby. Midwives/nurses were competent in using the skills and saw healthy conversations as an effective means of raising issues of diet and physical activity. Recent extension of maternity appointment times provides ideal opportunities to incorporate a brief intervention to support behaviour change. Incorporating HCS training into midwifery education and continuing professional development would facilitate this. HCS is a scalable, brief intervention with the potential to improve the diets and physical activity levels of women during pregnancy, and hence the health of themselves and their babies.