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WeChat-assisted dietary and exercise intervention for prevention of gestational diabetes mellitus in overweight/obese pregnant women: a two-arm randomized clinical trial.
Ding, B, Gou, B, Guan, H, Wang, J, Bi, Y, Hong, Z
Archives of gynecology and obstetrics. 2021;(3):609-618
Abstract
PURPOSE This study aimed to examine the influence of a WeChat-based dietary and exercise intervention on gestational diabetes mellitus (GDM) prevention in overweight/obese pregnant women in Beijing. METHODS Overweight/obese pregnant women were recruited in the early stages of pregnancy. After screening by include and exclude standards, eligible women were randomly divided into two groups, intervention and control groups. The control group received a general advice session about pregnancy nutrition and weight management. The intervention group received three face-to-face sessions about personalized dietary and exercise intervention, with the help of WeChat as a monitoring tool to promote treatment plan adherence. At 24-28 weeks of pregnancy, GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. Gestational weight gain (GWG), maternal and neonatal outcomes were also collected. RESULTS This study analyzed 215 participants. At the mid-trimester, 42 (37.8%) women in the control group were diagnosed with GDM (n = 111) versus 25 (24.5%) in the intervention group (n = 104; p < 0.05). The intervention group gained 11.2 ± 4.9 kg during the whole gestation period, with 4.9 ± 3.1 kg-weight increment in the first 25 weeks of pregnancy, versus 13.4 ± 5.0 kg and 6.9 ± 3.2 kg in the first 25 weeks in the control group (between groups: p < 0.001/p = 0.002). Incidence of macrosomia was not significantly lower in the intervention group than in the control group (8/7.9% vs 11/9.9%) (p > 0.05). No significant difference was found in the rate of natural labor and occurrence of perinatal complications (e.g., preterm birth, gestational hypertension, and preeclampsia) between the groups (p > 0.05). CONCLUSIONS The WeChat-assisted dietary and exercise intervention was effective in reducing the occurrence of GDM and excessive weight gain in overweight/obese pregnant women. Disseminating knowledge of pregnancy and childbirth through social media platforms like WeChat could be an important part of antenatal care.
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A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial.
Hendrixson, DT, Smith, K, Lasowski, P, Callaghan-Gillespie, M, Weber, J, Papathakis, P, Iversen, PO, Koroma, AS, Manary, MJ
PLoS medicine. 2021;(9):e1003618
Abstract
BACKGROUND Innovations for undernourished pregnant women that improve newborn survival and anthropometry are needed to achieve the Sustainable Development Goals 1 and 3. This study tested the hypothesis that a combination of a nutritious supplementary food and several proven chemotherapeutic interventions to control common infections would increase newborn weight and length in undernourished pregnant women. METHODS AND FINDINGS This was a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone. Women with a mid-upper arm circumference (MUAC) ≤23.0 cm presenting for antenatal care at one of 43 government health clinics in Western Rural Area and Pujehun districts were eligible for participation. Standard of care included a blended corn/soy flour and intermittent preventive treatment for malaria in pregnancy (IPTp). The intervention replaced the blended flour with RUSF and added azithromycin and testing and treatment for vaginal dysbiosis. Since the study involved different foods and testing procedures for the intervention and control groups, no one except the authors conducting the data analyses were blinded. The primary outcome was birth length. Secondary outcomes included maternal weight gain, birth weight, and neonatal survival. Follow-up continued until 6 months postpartum. Modified intention to treat analyses was undertaken. Participants were enrolled and followed up from February 2017 until February 2020. Of the 1,489 women enrolled, 752 were allocated to the intervention and 737 to the standard of care. The median age of these women was 19.5 years, of which 42% were primigravid. Twenty-nine women receiving the intervention and 42 women receiving the standard of care were lost to follow-up before pregnancy outcomes were obtained. There were 687 singleton live births in the intervention group and 657 in the standard of care group. Newborns receiving the intervention were 0.3 cm longer (95% confidence interval (CI) 0.09 to 0.6; p = 0.007) and weighed 70 g more (95% CI 20 to 120; p = 0.005) than those receiving the standard of care. Those women receiving the intervention had greater weekly weight gain (mean difference 40 g; 95% CI 9.70 to 71.0, p = 0.010) than those receiving the standard of care. There were fewer neonatal deaths in the intervention (n = 13; 1.9%) than in the standard of care (n = 28; 4.3%) group (difference 2.4%; 95% CI 0.3 to 4.4), (HR 0.62 95% CI 0.41 to 0.94, p = 0.026). No differences in adverse events or symptoms between the groups was found, and no serious adverse events occurred. Key limitations of the study are lack of gestational age estimates and unblinded administration of the intervention. CONCLUSIONS In this study, we observed that the addition of RUSF, azithromycin, more frequent IPTp, and testing/treatment for vaginal dysbiosis in undernourished pregnant women resulted in modest improvements in anthropometric status of mother and child at birth, and a reduction in neonatal death. Implementation of this combined intervention in rural, equatorial Africa may well be an important, practical measure to reduce infant mortality in this context. TRIAL REGISTRATION ClinicalTrials.gov NCT03079388.
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Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial.
Perichart-Perera, O, Mier-Cabrera, J, Flores-Robles, CM, Martínez-Cruz, N, Arce-Sánchez, L, Alvarado-Maldonado, IN, Montoya-Estrada, A, Romo-Yañez, J, Rodríguez-Cano, AM, Estrada-Gutierrez, G, et al
Nutrients. 2021;(1)
Abstract
The aim of this study was to examine the efficacy of intensive medical nutrition therapy (MNT) plus metformin in preventing gestational diabetes mellitus (GDM) among high-risk Mexican women. An open-label randomized clinical trial was conducted. Inclusion criteria were pregnant women with three or more GDM risk factors: Latino ethnic group, maternal age >35 years, body mass index >25 kg/m2, insulin resistance, and a history of previous GDM, prediabetes, a macrosomic neonate, polycystic ovarian syndrome, or a first-degree relative with type 2 diabetes. Women before 15 weeks of gestation were assigned to group 1 (n = 45): intensive MNT-plus metformin (850 mg twice/day) or group 2 (n = 45): intensive MNT without metformin. Intensive MNT included individual dietary counseling, with ≤50% of total energy from high carbohydrates. The primary outcome was the GDM incidence according to the International Association of Diabetes Pregnancy Study Groups criteria. There were no significant differences in baseline characteristics and adverse perinatal outcomes between the groups. The GDM incidence was n = 11 (24.4%) in the MNT plus metformin group versus n = 7 (15.5%) in the MNT without metformin group: p = 0.42 (RR: 1.57 [95% CI: 0.67-3.68]). There is no benefit in adding metformin to intensive MNT to prevent GDM among high-risk Mexican women. Clinical trials registration: NCT01675310.
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Modifiable Determinants of Postpartum Weight Loss in Women with Obesity: A Secondary Analysis of the UPBEAT Trial.
Dalrymple, KV, Uwhubetine, O, Flynn, AC, Pasupathy, D, Briley, AL, Relph, SA, Seed, PT, O'Keeffe, M, Poston, L
Nutrients. 2021;(6)
Abstract
Pregnancy can alter a woman's weight gain trajectory across the life course and contribute to the development of obesity through retention of weight gained during pregnancy. This study aimed to identify modifiable determinants associated with postpartum weight retention (PPWR; calculated by the difference in pre-pregnancy and 6 month postpartum weight) in 667 women with obesity from the UPBEAT study. We examined the relationship between PPWR and reported glycaemic load, energy intake, and smoking status in pregnancy, excessive gestational weight gain (GWG), mode of delivery, self-reported postpartum physical activity (low, moderate, and high), and mode of infant feeding (breast, formula, and mixed). At the 6 month visit, 48% (n = 320) of women were at or above pre-pregnancy weight. Overall, PPWR was negative (-0.06 kg (-42.0, 40.4)). Breastfeeding for ≥4 months, moderate or high levels of physical activity, and GWG ≤9 kg were associated with negative PPWR. These three determinants were combined to provide a modifiable factor score (range 0-3); for each added variable, a further reduction in PPWR of 3.0 kg (95% confidence interval 3.76, 2.25) occurred compared to women with no modifiable factors. This study identified three additive determinants of PPWR loss. These provide modifiable targets during pregnancy and the postnatal period to enable women with obesity to return to their pre-pregnancy weight.
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Metabolic syndrome in obesity: treatment success and adverse pregnancy outcomes with ovulation induction in polycystic ovary syndrome.
Arya, S, Hansen, KR, Peck, JD, Wild, RA, ,
American journal of obstetrics and gynecology. 2021;(3):280.e1-280.e11
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Abstract
BACKGROUND Obesity is common in women with polycystic ovary syndrome. polycystic ovary syndrome and obesity are associated with reduced fertility. The effect of metabolic syndrome on the success of infertility treatment and pregnancy outcomes in women with polycystic ovary syndrome undergoing ovulation induction has not been investigated. OBJECTIVE The objectives of this study were to determine the associations of metabolic syndrome on the rate of live birth after ovulation induction and pregnancy complications in obese women with polycystic ovary syndrome and determine whether there is a difference in outcomes concerning specific medications used for ovulation induction. STUDY DESIGN This prospective cohort analysis used data collected from participants in the Pregnancy in Polycystic Ovary Syndrome II clinical trial conducted by the Reproductive Medicine Network. In the Pregnancy in Polycystic Ovary Syndrome II trial, 750 women with polycystic ovary syndrome and infertility were randomized to either clomiphene citrate or letrozole for ovulation induction for 1 to 5 cycles or until pregnancy occurred. Cox regression and modified Poisson regression, chi-square test, and Student t test or Wilcoxon test were used in this study. Outcomes of interest were rates of live birth and clinical pregnancy and pregnancy complications. Having metabolic syndrome was defined by the presence of at least 3 of 5 cardiometabolic risk factors (waist circumference of >88 cm, low high-density lipoprotein cholesterol of <50 mg/dL, triglycerides of ≥150 mg/dL, systolic blood pressure of ≥130 or diastolic blood pressure of ≥85 mm Hg, and fasting glucose of >100 mg/dL). In addition, we used a continuous metabolic syndrome z score. Body mass index categories were defined as normal (body mass index of <25 kg/m2), high (25 to 35 kg/m2), and very high (>35 kg/m2). RESULTS As illustrated in the Table, early pregnancy losses showed no difference by metabolic syndrome. Fewer women achieved a clinical pregnancy (20.5% vs 29.7%; P=.007) or had a live birth (16.5% vs 27%; P=.001) in the presence of metabolic syndrome. Early pregnancy losses showed no difference by metabolic syndrome status. However, at least 1 pregnancy complication occurred more often with metabolic syndrome: 61.9% (26 of 42 cases) with metabolic syndrome vs 44.4% (59 of 133 cases) (P=.05) without metabolic syndrome. Gestational diabetes mellitus (35.7% vs 18.2%; P=.02) and macrosomia (21.4% vs 8.3%; P=.02) were more common in the presence of metabolic syndrome. After adjustment for other potential confounders, the rate ratio for live births for a 1-unit change in the metabolic syndrome z score was 0.89 (95% confidence interval, 0.79-1.00; P=.04) for those whose body mass index was 25 to 35 kg/m2. For the very high body mass index subgroup (>35 kg/m2), the independent effects of metabolic syndrome from obesity were harder to discern. The rate of live birth was higher with the use of letrozole, although metabolic syndrome had a different detrimental effect concerning the medication given. The overall incidence of pregnancy complications was high (approximately 49%) in the Pregnancy in Polycystic Ovary Syndrome II trial and the 2 medications. Letrozole was associated with more obstetrical complications in the presence of metabolic syndrome, and clomiphene was associated with a lower rate of live birth rate when metabolic syndrome was present. CONCLUSION Metabolic syndrome is a risk factor that lowers the rate of live birth after ovulation for women with polycystic ovary syndrome, independent of obesity, and it is particularly associated with a lower rate of live birth for women using clomiphene compared with women using letrozole. In addition, metabolic syndrome is a risk factor for pregnancy complications for women with obesity using letrozole. Furthermore, having metabolic syndrome is a risk factor for gestational diabetes mellitus and macrosomia.
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The effect of high dietary fiber intake on gestational weight gain, fat accrual, and postpartum weight retention: a randomized clinical trial.
Hull, HR, Herman, A, Gibbs, H, Gajewski, B, Krase, K, Carlson, SE, Sullivan, DK, Goetz, J
BMC pregnancy and childbirth. 2020;(1):319
Abstract
BACKGROUND Interventions to prevent excessive gestational weight gain (GWG) have had limited success This pilot study examined the effectiveness of a single goal (SG) high dietary fiber intervention to prevent excessive GWG. METHODS Twelve weekly lessons focused on consuming a high fiber diet (≥30 g/day). Snacks containing 10-12 g of dietary fiber were given for the first 6 weeks only. Body composition was measured at baseline and at the end of the intervention. At one-year postpartum, body weight retention and dietary practices were assessed. A p-value is reported for the primary analysis only. For all other comparisons, Cohen's d is reported to indicate effect size. RESULTS The SG group increased fiber intake during the study (32 g/day at 6 weeks, 27 g/day at 12 weeks), whereas the UC group did not (~ 17 g/day). No differences were found for the proportion of women classified as excessive gainers (p = 0.13). During the intervention, the SG group gained less body weight (- 4.1 kg) and less fat mass (- 2.8 kg) (d = 1.3). At 1 year postpartum, the SG group retained less weight (0.35 vs. 4.4 kg, respectively, d = 1.8), and reported trying to currently eat high fiber foods. CONCLUSION The SG intervention resulted in less weight gain, fat accrual, and weight retention at 1 year postpartum. A residual intervention effect was detected postpartum with the participants reporting continued efforts to consume a high fiber diet. TRIAL REGISTRATION NCT03984630; Trial registered June 13, 2019 (retrospectively registered).
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Water Exercise and Quality of Life in Pregnancy: A Randomised Clinical Trial.
Rodríguez-Blanque, R, Aguilar-Cordero, MJ, Marín-Jiménez, AE, Menor-Rodríguez, MJ, Montiel-Troya, M, Sánchez-García, JC
International journal of environmental research and public health. 2020;(4)
Abstract
Background: Physical exercise helps to maintain a healthy lifestyle and its practice is recommended for women during pregnancy as a means of limiting the negative effects on the body that may take place and to optimise well-being, mood and sleep patterns, as well as encouraging daily physical activity, enhancing the ability to work and preventing pregnancy-related complications. Aim: To analyse the quality of life in pregnancy for women who complete a programme of moderate physical activity in water, following a designed method that the woman can perform physical exercise safely during pregnancy called the SWEP (study of water exercise during pregnancy) method. Materialsand methods: A randomised clinical trial was performed. One hundred and twenty-nine pregnant women were randomly assigned either to an exercise class following the SWEP method (EG, n = 65) or to a control group (CG, n = 64). The trial began in week 20 of pregnancy (May 2016) and ended in week 37 (October 2016). Heath-related quality of life (HRQoL) was evaluated with the SF36v2 health questionnaire at weeks 12 and 35 of pregnancy. Results: The HRQoL score decreased significantly between weeks 12 and 35 of gestation, except for the mental health component, which in the CG fell by -3.28 points and in the EG increased slightly (p > 0.05). Among the CG, the score for the mental health component at week 35 was ≤42, indicating a positive screening risk of depression (39.20 ± 4.16). Conclusions: Physical activity programmes in water, such as SWEP, enhance the HRQoL of pregnant women.
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Use of healthy conversation skills to promote healthy diets, physical activity and gestational weight gain: Results from a pilot randomised controlled trial.
Adam, LM, Jarman, M, Barker, M, Manca, DP, Lawrence, W, Bell, RC
Patient education and counseling. 2020;(6):1134-1142
Abstract
OBJECTIVES This study evaluated the use of Healthy Conversation Skills (a client-centered communication approach to behaviour change) in supporting women to achieve optimal gestational-weight-gain and health behaviours. METHODS Seventy pregnant women were randomised to the control or intervention group. Study visits and phone calls were delivered by Registered Dietitians (RDs) to women in the intervention and control groups. The intervention RD was trained in Healthy Conversation Skills while the control RD was not. Diet, physical activity and gestational-weight-gain were assessed at baseline and again at follow-up in the intervention and control groups. RESULTS Women in the intervention group improved their diet score between baseline and visit 2, while the control group did not. At 34 weeks, women in the control group reported being sedentary for longer than women in the intervention group. There were no differences in total gestational-weight-gain between the groups. CONCLUSIONS Pregnant women who interacted with an RD using Healthy Conversation Skills reported positive outcomes in health behaviours. PRACTICE IMPLICATIONS Healthy Conversation Skills shows promise as an approach to initiate, and maintain discussions promoting health behaviour change in pregnancy.
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Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial.
Nagpal, TS, Prapavessis, H, Campbell, CG, de Vrijer, B, Bgeginski, R, Hosein, K, Paplinskie, S, Manley, M, Mottola, MF
International journal of behavioral medicine. 2020;(1):108-118
Abstract
BACKGROUND Adhering to nutrition and exercise recommendations simultaneously during pregnancy may be challenging. The purpose was to examine adherence to the sequential introduction of nutrition and exercise behaviors during pregnancy in comparison with a simultaneous approach. METHOD A randomized controlled trial including nutrition and exercise was executed. Using a stratified body mass index (BMI) randomization, participants (n = 88) were allocated to one of three groups at 12-18 weeks gestation. Group A received nutrition and exercise simultaneously. Group B received nutrition first and Group C received exercise first, and the second behavior was added at 25 weeks gestation for both groups. The program included weekly weighing, supervised walking sessions, and/or nutrition counseling. Adherence (primary outcome) was measured by scoring women on meeting the intervention goals (3 nutrition and 3 exercise goals) and converted to a percentage. Secondary health outcomes were gestational weight gain (GWG) and excessive GWG on the program, birthweight, macrosomia (birthweight > 4000 g), and low birthweight (birthweight < 2500 g). RESULTS Group C (n = 23) had the highest adherence to the program (80.2 ± 14.7%) compared with Groups A (n = 17; 60.9 ± 17.9%) and B (n = 20; 66.8 ± 16.7%; p < 0.05, ηp2 = 0.26). There was a significant effect for gestational weight gain (p < 0.05; ηp2 = 0.10) as Group C gained less weight (7.7 ± 2.2 kg) over Group B (9.8 ± 2.8 kg; p = 0.04), however, not Group A (9.1 ± 3.5, p = 0.35). Non-significant small effects favored Group C for the prevention of EGWG (Cramer's V = 0.13). CONCLUSION Introducing exercise first followed by nutrition at 25 weeks gestation can improve adherence to multiple behavior change programs and thus have a positive effect on health outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02804061.
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An early intervention to promote maternal sensitivity in the perinatal period for women with psychosocial vulnerabilities: study protocol of a randomized controlled trial.
Aarestrup, AK, Skovgaard Væver, M, Petersen, J, Røhder, K, Schiøtz, M
BMC psychology. 2020;(1):41
Abstract
BACKGROUND Maternal mental well-being and social circumstances during pregnancy and early childhood impact the child's well-being and development. Supportive and sensitive parenting is one of the strongest predictors of positive emotional, social and behavioral outcomes for the child. Knowledge is needed about how to detect and support vulnerable families already during pregnancy and in the postnatal period. The aim of this study is to assemble and evaluate an interdisciplinary cross-sectoral intervention to promote maternal sensitivity among women with psychological or social vulnerabilities. METHODS/DESIGN This randomized controlled trial tests the efficacy of an intervention program in the perinatal period compared to care as usual in enhancing maternal sensitivity in a group of psychologically or socially vulnerable women in the Capital Region of Denmark. The intervention consists of four components: 1) detecting symptoms of mental illness in vulnerable pregnant women and initiating treatment if indicated, 2) strengthening parenting skills using the Circle of Security Parenting program, 3) supporting breastfeeding, and 4) sharing knowledge and organizing treatment pathways for families across sectors. Seventy-six families will be randomly assigned to the intervention or care-as-usual. Data will be obtained at study inclusion at 3-5 months of pregnancy, eight weeks after childbirth, and nine months after childbirth. The primary outcome is maternal sensitivity. Secondary outcomes include infant's socio-emotional development, parents' mentalization, parental stress, depressive symptoms, and parental wellbeing. Qualitative data will provide insight into the implementation process. DISCUSSION This paper presents the rational and background for developing the intervention. Furthermore, the design and protocol of the randomized controlled trial. It is hypothesized that the intervention will be associated with positive changes in primary and secondary outcomes. If effective, the intervention will provide insights into prenatal risk profiles among an identified group of psychosocial vulnerable women important for early screening and point to effective preventive interventions that can support women in the perinatal period, increase maternal sensitivity and promote positive child development -starting before the child is born. TRIAL REGISTRATION ClinicalTrials.gov: ID: NCT03190707. Registered June 16, 2017.