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Effects of a lifestyle intervention during pregnancy to prevent excessive gestational weight gain in routine care - the cluster-randomised GeliS trial.

ABSTRACT: BACKGROUND:Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity. METHODS:The GeliS study is a cluster-randomised multicentre controlled trial including 2286 women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 recruited from gynaecological and midwifery practices prior to the end of the 12th week of gestation in five Bavarian regions. In the intervention regions, four lifestyle counselling sessions covering a balanced healthy diet, regular physical activity and self-monitoring of weight gain were performed by trained healthcare providers alongside routine pre- and postnatal practice visits. In the control regions, leaflets with general recommendations for a healthy lifestyle during pregnancy were provided. RESULTS:The intervention did not result in a significant reduction of women showing excessive GWG (adjusted OR 0.95, 95% CI 0.66-1.38, p = 0.789), with 45.1% and 45.7% of women in the intervention and control groups, respectively, gaining weight above the Institute of Medicine recommendations. Gestational diabetes mellitus was diagnosed in 10.8% and 11.1% of women in the intervention and control groups, respectively (p = 0.622). Mean birth weight and length were slightly lower in the intervention group (3313 ± 536 g vs. 3363 ± 498 g, p = 0.020; 51.1 ± 2.7 cm vs. 51.6 ± 2.5 cm, p = 0.001). CONCLUSION:In the setting of routine prenatal care, lifestyle advice given by trained healthcare providers was not successful in limiting GWG and pregnancy complications. Nevertheless, the potential long-term effects of the intervention remain to be assessed. TRIAL REGISTRATION:NCT01958307 , ClinicalTrials.gov, retrospectively registered October 9, 2013.

SUBMITTER: Kunath J

PROVIDER: S-EPMC6330753 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Effects of a lifestyle intervention during pregnancy to prevent excessive gestational weight gain in routine care - the cluster-randomised GeliS trial.

Kunath Julia J Günther Julia J Rauh Kathrin K Hoffmann Julia J Stecher Lynne L Rosenfeld Eva E Kick Luzia L Ulm Kurt K Hauner Hans H

BMC medicine 20190114 1

<h4>Background</h4>Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity.<h4>Methods</h4>The GeliS study is a cluster-randomised multicentre controlled trial including ...[more]

PMID: 30636636

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Project description:BackgroundExcessive gestational weight gain (GWG) and gestational diabetes mellitus (GDM) are common pregnancy complications that have been shown to be preventable through the use of lifestyle interventions. However, a significant gap exists between research on pregnancy lifestyle interventions and translation into clinical practice. App-supported interventions might aid in overcoming previous implementation barriers. The current status in this emerging research area is unknown.ObjectiveThis scoping review aims to provide a comprehensive overview of planned, ongoing, and completed studies on eHealth and mobile health (mHealth) app-supported lifestyle interventions in pregnancy to manage GWG and prevent GDM. The review assesses the scope of the literature in the field; describes the population, intervention, control, outcomes, and study design (PICOS) characteristics of included studies as well as the findings on GWG and GDM outcomes; and examines app functionalities.MethodsThe scoping review was conducted according to a preregistered protocol and followed established frameworks. Four electronic databases and 2 clinical trial registers were systematically searched. All randomized and quasi-randomized controlled trials (RCTs) of app-supported lifestyle interventions in pregnancy and related qualitative and quantitative research across the different study phases were considered for inclusion. Eligible studies and reports of studies were included until June 2022. Extracted data were compiled in descriptive analyses and reported in narrative, tabular, and graphical formats.ResultsThis review included 97 reports from 43 lifestyle intervention studies. The number of published reports has steadily increased in recent years; of the 97 included reports, 38 (39%) were trial register entries. Of the 39 identified RCTs, 10 efficacy or effectiveness trials and 8 pilot trials had published results on GWG (18/39, 46%); of these 18 trials, 7 (39%) trials observed significant intervention effects on GWG outcomes. Of all 39 RCTs, 5 (13%) efficacy or effectiveness trials reported GDM results, but none observed significant intervention effects on GDM. The RCTs included in the review were heterogeneous in terms of their PICOS characteristics. Most of the RCTs were conducted in high-income countries, included women with overweight or obesity and from all BMI categories, delivered multicomponent interventions, delivered interventions during pregnancy only, and focused on diet and physical activity. The apps used in the studies were mostly mHealth apps that included features for self-monitoring, feedback, goal setting, prompts, and educational content. Self-monitoring was often supported by wearable activity monitors and Bluetooth-connected weight scales.ConclusionsResearch in this field is nascent, and the effectiveness and implementability of app-supported interventions have yet to be determined. The complexity and heterogeneity of intervention approaches pose challenges in identifying the most beneficial app features and intervention components and call for consistent and comprehensive intervention and outcome reporting.

Project description:Excessive pre-pregnancy weight is a known risk factor of pregnancy complications. The purpose of this analysis was to assess the relationship between several categories of maternal weight and the risk of developing hypertension and diabetes in pregnancy, and the relationship of these complications with the results of the newborn. It was carried out in a common cohort of pregnant women and taking into account the influence of disturbing factors. Our analysis was conducted in a prospective cohort of 912 Polish pregnant women, recruited during 2015-2016. We evaluated the women who subsequently developed diabetes with dietary modification (GDM-1) (n = 125) and with insulin therapy (GDM-2) (n = 21), as well as the women who developed gestational hypertension (GH) (n = 113) and preeclampsia (PE) (n = 24), compared to the healthy controls. Odds ratios of the complications (and confidence intervals (95%)) were calculated in the multivariate logistic regression. In the cohort, 10.8% of the women had pre-pregnancy obesity (body mass index (BMI) ? 30 kg/m2), and 36.8% had gestational weight gain (GWG) above the range of the Institute of Medicine recommendation. After correction for excessive GWG and other confounders, pre-pregnancy obesity (vs. normal BMI) was associated with a higher odds ratio of GH (AOR = 4.94; p < 0.001), PE (AOR = 8.61; p < 0.001), GDM-1 (AOR = 2.99; p < 0.001), and GDM-2 (AOR = 11.88; p <0.001). The threshold risk of development of GDM-2 occurred at lower BMI values (26.9 kg/m2), compared to GDM-1 (29.1 kg/m2). The threshold point for GH was 24.3 kg/m2, and for PE 23.1 kg/m2. For GWG above the range (vs. GWG in the range), the adjusted odds ratios of GH, PE, GDM-1, and GDM-2 were AOR = 1.71 (p = 0.045), AOR = 1.14 (p = 0.803), AOR = 0.74 (p = 0.245), and AOR = 0.76 (p = 0.672), respectively. The effect of maternal edema on all the results was negligible. In our cohort, hypertension and diabetes were associated with incorrect birth weight and gestational age at delivery. Conclusions: This study highlights the importance and influence of excessive pre-pregnancy maternal weight on the risk of pregnancy complications such as diabetes and hypertension which can impact fetal outcomes.

Project description:Excessive gestational weight gain (GWG) is associated with elevated weight retention in mothers and might be related to adiposity of their offspring. Little is known if lifestyle intervention during pregnancy has beneficial effects for mothers and children beyond gestation.A cluster-randomized controlled intervention trial was performed with 250 pregnant women in 8 gynaecological practices. Lifestyle intervention was carried out twice with individual counselling sessions on nutrition, physical activity and weight monitoring. Participants in the control group received routine prenatal care and an information leaflet. Follow-up data of women and their offspring were collected one year postpartum (pp) by phone call and/or via e-mail using a structured questionnaire. Maternal weight retention at 12 months pp and weight development of the children in their first year of life was compared between groups using linear regression. The association between energy and macronutrient intake during pregnancy with maternal weight retention and children weight development was also assessed.The intervention resulted in a trend towards lower mean weight retention 12 months pp (0.2 vs. 0.8 kg), but was not statistically significant (p = 0.321). Among women receiving lifestyle counselling, only 8% retained more than 5 kg weight while 17% in the control group retained >5 kg (OR: 0.40 (95% CI: 0.16, 0.97)). For the whole study cohort, an association between higher GWG and increased 12 month weight retention was found (0.4 kg weight retention per 1 kg increase in GWG, p < 0.001). Weight development of the infants did not differ between groups in the first months after birth. At the 10th-12th month weight measurement, infants born to mothers in the intervention group tended towards lower body weights. Both energy intake and macronutrient composition of the diet during pregnancy did not affect maternal weight retention and weight development of the infants.Lifestyle counselling during pregnancy to avoid GWG had a rather modest effect on maternal pp weight retention and weight development of the infants. However, larger intervention studies and longer follow-up are required to be able to draw definite conclusions.German Clinical Trials Register DRKS00003801.

Project description:BackgroundBehavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking.ObjectiveA randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care.DesignParticipants (n = 257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016. Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic. Women were randomly assigned within site and by ethnicity to enhanced usual care (n = 128) or to a behavioral lifestyle intervention with partial meal replacement (n = 129). The primary outcome was GWG per week of observation. Secondary outcomes were proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications. Study retention was 99.6% (256 of 257).ResultsThe intervention compared with usual care resulted in less mean ± SD weekly GWG (0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk; P = 0.02) and total GWG (9.4 ± 6.9 compared with 11.2 ± 7.0 kg; P = 0.03) and reduced the proportion of women who exceeded IOM guidelines for total GWG (41.1% compared with 53.9%; P = 0.03). No significant group × time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions were observed. Among intervention participants, greater meal replacement intake was related to reduced GWG rate (β = -0.07; 95% CI:-0.12, -0.03; P = 0.002). The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03).ConclusionPrenatal behavioral intervention with partial meal replacement significantly reduced GWG in Hispanic and non-Hispanic women with overweight or obesity. This trial was registered at www.clinicaltrials.gov as NCT01545934.

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Effects of a lifestyle intervention during pregnancy to prevent excessive gestational weight gain in routine care - the cluster-randomised GeliS trial.

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Effects of a lifestyle intervention during pregnancy to prevent excessive gestational weight gain in routine care - the cluster-randomised GeliS trial.

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