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Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity.

ABSTRACT: The Lifestyle Interventions for Expectant Moms (LIFE-Moms) Consortium is designed to determine, in pregnant women with overweight or obesity, whether various behavioral and lifestyle interventions reduce excessive gestational weight gain (GWG) and subsequent adverse maternal and neonatal outcomes and obesity in offspring. The design and planning process of the LIFE-Moms Consortium is described.The LIFE-Moms Consortium is a collaboration among seven clinical centers, a Research Coordinating Unit, and the NIH designed to support each clinical center's conduct of a separate trial of a unique intervention. Specific common measures, procedures, and eligibility criteria are consistent across the seven trials allowing data to be combined in exploratory analyses and/or compared readily.Numerous committees and working groups were created to define common measures and outcomes during pregnancy and through 1 year postpartum, develop Consortium policies, and oversee progress of the trials. The primary outcome for the Consortium is excessive GWG. Secondary outcomes include maternal, neonatal, and infant anthropometric measures, physical activity, sleep, and complications of pregnancy and delivery.A multi-center consortium of independent, lifestyle interventions with common measures and outcomes may enhance the ability to identify promising interventions for improving outcomes in pregnant women and their offspring.

SUBMITTER: Clifton RG

PROVIDER: S-EPMC4731277 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity.

Clifton Rebecca G RG Evans Mary M Cahill Alison G AG Franks Paul W PW Gallagher Dympna D Phelan Suzanne S Pomeroy Jeremy J Redman Leanne M LM Van Horn Linda L

Obesity (Silver Spring, Md.) 20151226 2

<h4>Objective</h4>The Lifestyle Interventions for Expectant Moms (LIFE-Moms) Consortium is designed to determine, in pregnant women with overweight or obesity, whether various behavioral and lifestyle interventions reduce excessive gestational weight gain (GWG) and subsequent adverse maternal and neonatal outcomes and obesity in offspring. The design and planning process of the LIFE-Moms Consortium is described.<h4>Methods</h4>The LIFE-Moms Consortium is a collaboration among seven clinical cent ...[more]

PMID: 26708836

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Project description: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.

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:BackgroundInappropriate gestational weight gain (GWG) has been associated with adverse perinatal events. High rates of GWG have been reported among Hispanic women. Observational studies indicate that dietary and physical activity interventions during the prenatal period may improve maternal and infant health, but very few randomized trials have been conducted among high-risk overweight/obese Hispanic women. Accordingly, we conducted a lifestyle intervention among high-risk pregnant women and evaluated its impact on achieving appropriate GWG and on improving birthweight.MethodsEligible overweight/obese women presenting at the University Hospital in Puerto Rico with a singleton pregnancy before 16 gestational weeks were recruited and randomized to lifestyle intervention (n=15) or control group (n=16). The lifestyle intervention focused on improving physical activity and diet quality and optimizing caloric intake. We evaluated the impact of the lifestyle intervention on achieving appropriate GWG and on infant birthweight. Poisson and linear regression analyses were performed.ResultsThe primary intent to treat analysis showed no significant effect on achievement of appropriate GWG/week through 36 weeks in the intervention group (4/15 women) when compared with the control group (3/16 women) (adjusted incidence rate ratio =1.14; 95% CI: 0.20, 6.67). Although not statistically significant, women in the intervention group (6/15) were 1.7 times more likely to achieve appropriate weekly GWG until delivery when compared with controls (4/16 women) (adjusted incidence rate ratio = 1.67; 95% CI: 0.40, 6.94). We observed lower adjusted birthweight-for-length z-scores in the intervention compared with the control group among male newborns with z-score difference -1.74 (-3.04, -0.43), but not among females -0.83 (-3.85, 2.19). These analyses were adjusted for age and baseline body mass index.ConclusionAlthough larger studies are required to determine whether women with obesity may benefit from prenatal lifestyle interventions targeting GWG, our results are suggestive of the intervention improving adherence to established Institute of Medicine guidelines.

Project description:Background:Behavioral 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. Objective:A 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. Design:Participants (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). Results:The 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 (? = -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). Conclusion:Prenatal 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.

Project description:BackgroundOverweight and obesity amongst women of reproductive age are increasingly common in developed economies and are shown to adversely affect birth outcomes and both childhood and adulthood health risks in the offspring. Metabolic profiling in conditions of overweight and obesity in pregnancy could potentially be applied to elucidate the molecular basis of the adverse effects of gestational weight gain (GWG) and postpartum weight loss (WL) on future risks for cardiovascular disease (CVD) and other chronic diseases.MethodsBiofluid samples were collected from 114 ethnically diverse pregnant women with body mass index (BMI) between 25 and 40 kg/m2 from Chicago (US), as part of a randomized lifestyle intervention trial (Maternal Offspring Metabolics: Family Intervention Trial; NCT01631747). At 15 weeks, 35 weeks of gestation, and at 1 year postpartum, the blood plasma lipidome and metabolic profile of urine samples were analyzed by liquid chromatography mass spectrometry (LC-MS) and 1H nuclear magnetic resonance spectroscopy (1H NMR) respectively.ResultsUrinary 4-deoxyerythronic acid and 4-deoxythreonic acid were found to be positively correlated to BMI. Seventeen plasma lipids were found to be associated with GWG and 16 lipids were found to be associated with WL, which included phosphatidylinositols (PI), phosphatidylcholines (PC), lysophospholipids (lyso-), sphingomyelins (SM) and ether phosphatidylcholine (PC-O). Three phospholipids found to be positively associated with GWG all contained palmitate side-chains, and amongst the 14 lipids that were negatively associated with GWG, seven were PC-O. Six of eight lipids found to be negatively associated with WL contained an 18:2 fatty acid side-chain.ConclusionsMaternal obesity was associated with characteristic urine and plasma metabolic phenotypes, and phospholipid profile was found to be associated with both GWG and postpartum WL in metabolically healthy pregnant women with overweight/obesity. Postpartum WL may be linked to the reduction in the intake of linoleic acid/conjugated linoleic acid food sources in our study population.

Project description:BackgroundExcessive weight gain during pregnancy and subsequent postpartum weight retention may contribute to the epidemic of obesity among women of childbearing age. Preventing excessive gestational weight gain (GWG) to optimize maternal, fetal and infant wellbeing is therefore of great importance. A number of dietary interventions in this area has been conducted with inconsistent results, which has made it difficult to identify effective strategies to prevent excessive weight gain during pregnancy among normal weight, overweight and obese women. The primary objective of this review was to evaluate the effect of dietary interventions for reducing GWG. The secondary objective was to examine the impact of these interventions on different child and maternal health outcomes.MethodThe PUBMED, the Cochrane Central Register of Controlled Trials (CENTRAL) and the LILACS databases were searched for relevant articles. All published randomized controlled trials (RCT) and quasi-randomized controlled trials (QCT), with concurrent controls, on dietary interventions during pregnancy were considered. Results were presented using relative risk (RR) for categorical data and weighted mean difference (WMD) for continuous data. Data were primarily analyzed with a fixed-effect model and a random-effects model was used in the presence of heterogeneity. No date and language restrictions were applied.ResultsIn total, 13 studies were included in this review and 10 trials contributed data on total GWG. Dietary intervention significantly reduced total GWG (n = 1434; WMD = -1.92 kg; 95% CI = -3.65/-0.19; p = 0.03), weight retention at six months postpartum (n = 443; WMD = -1.90 kg; 95% CI = -2.69/-1.12; p < 0.0001) and incidence of cesarean section (n = 609; RR = 0.75; 95% CI = 0.60/0.94; p = 0.013). However, dietary intervention had no significant effect on weight retention at six weeks postpartum, birth weight, preeclampsia, gestational diabetes and preterm birth.ConclusionDietary advice during pregnancy appears effective in decreasing total GWG and long-term postpartum weight retention, but so far there is limited evidence for further benefits on infant and maternal health.

Dataset Information

Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity.

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Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity.

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