Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity.
ABSTRACT: BACKGROUND:Excess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have been designed for implementation in healthcare settings. METHODS:We describe the development, rationale, and methods of GLOW (GestationaL Weight Gain and Optimal Wellness), a randomized controlled trial evaluating the efficacy of a lifestyle intervention to prevent excess GWG among racially/ethnically diverse women with overweight or obesity in an integrated healthcare delivery system. Participants in Kaiser Permanente Northern California will be randomized, within 2?weeks of completing a study baseline clinic visit at 10?weeks' gestation, to either usual medical care or a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (target N?=?400). Informed by focus groups with patients and designed to be feasible in a clinical setting, the intervention will include 13 weekly individual sessions (11 delivered by telephone) focused on behavior change for weight management, healthy eating, physical activity, and stress management. Outcomes will be assessed in women and their infants from randomization to 12?months postpartum. The primary outcome is GWG. Secondary outcomes include changes in diet and physical activity during pregnancy and infant birthweight. Exploratory outcomes include cardiometabolic profile assessed via pregnancy blood samples and cord blood samples; and postpartum weight retention and infant anthropometrics up to 12?months of age. The trial includes systematic approaches to enhance intervention fidelity, intervention adherence, and participant retention in trial assessments. DISCUSSION:GLOW is among few trials targeting excess GWG among diverse women with overweight or obesity in a healthcare setting, with long-term maternal and infant outcomes assessed up to 12?months after delivery. This evaluation of a multi-component intervention is designed to produce generalizable results to inform potential adoption of the intervention in clinical settings. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02130232 ): submitted April 30, 2014; posted May 5, 2014.
Project description:BACKGROUND: Excessive 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. METHOD: The 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. RESULTS: In 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. CONCLUSION: Dietary 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.
Project description:The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.NCT01868230 May 29, 2013.
Project description:BACKGROUND:Evidence from epidemiological and animal studies support the concept of programming fetal, neonatal, and adult health in response to in utero exposures such as maternal obesity and lifestyle variables. Excess gestational weight gain (GWG), maternal physical activity, and sub-optimal and excess nutrition during pregnancy may program the offspring's risk of obesity. Maternal intake of dairy foods rich in high-quality proteins, calcium, and vitamin D may influence later bone health status. Current clinical practice guidelines for managing GWG are not founded on randomized trials and lack specific "active intervention ingredients." The Be Healthy in Pregnancy (BHIP) study is a randomized controlled trial (RCT) designed to test the effectiveness of a novel structured and monitored Nutrition + Exercise intervention in pregnant women of all pre-pregnancy weight categories (except extreme obesity), delivered through prenatal care in community settings (rather than in hospital settings), on the likelihood of women achieving recommended GWG and a benefit to bone status of offspring and mother at birth and six?months postpartum. METHODS:The BHIP study is a two-site RCT that will recruit up to 242 participants aged >?18?years at 12-17 weeks of gestation. After baseline measures, participants are randomized to either a structured and monitored Nutrition + Exercise (intervention) or usual care (control) program for the duration of their pregnancy. The primary outcome of the study is the percent of women who achieve GWG within the Institute of Medicine (IOM) guidelines. The secondary outcomes include: (1) maternal bone status via blood bone biomarkers during pregnancy; (2) infant bone status in cord blood; (3) mother and infant bone status measured by dual-energy absorptiometry scanning (DXA scan) at six?months postpartum; (4) other measures including maternal blood pressure, blood glucose and lipid profiles, % body fat, and postpartum weight retention; and (5) infant weight z-scores and fat mass at six?months of age. DISCUSSION:If effective, this RCT will generate high-quality evidence to refine the nutrition guidelines during pregnancy to improve the likelihood of women achieving recommended GWG. It will also demonstrate the importance of early nutrition on bone health in the offspring. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01689961 Registered on 21 September 2012.
Project description:BACKGROUND: The increasing prevalence of obesity in pregnant women is associated with adverse maternal and neonatal outcomes, and increased costs to healthcare, the economy and broader society. OBJECTIVES: To assess the efficacy of behavioural interventions for managing gestational weight gain (GWG) in the pre-conceptual and pregnancy period in overweight, obese and morbidly obese women. SEARCH METHODS: A search was performed for published studies in the English language, from date? 2000-31 December 2012 in five electronic databases; PubMed, Scopus, Cochrane Library, CINAHL and PsycINFO. SELECTION CRITERIA: Studies were included if they compared the efficacy or effectiveness of a particular behavioural intervention in pregnant or pre-conceptual women with standard maternity care. Studies that included women with co-morbid conditions such as diabetes mellitus and polycystic ovarian syndrome were excluded to help isolate the effect of the intervention. RESULTS: Fifteen studies involving 3,426 participants were included. One study (n = 692) focused on the pre-conceptual period and the remaining 14 (n = 2,734) in the pregnancy period. Pooled mean difference for GWG indicated a lower GWG in the intervention groups when compared to standard maternity care groups (n = 1771, mean difference (MD) -1.66 kg, 95% CI -3.12 to -0.21 kg). With respect to the types of participants, considerable heterogeneity between studies was shown in the obese subgroup [Tau(2) = 15.61; Chi(2) = 40.80, df = 3 (P<0.00001); I(2) = 93%]. CONCLUSIONS: Behavioural interventions in pregnancy may be effective in reducing GWG in obese women without comorbid conditions, but not overweight or morbidly obese women. Behavioural interventions had no effect on postpartum weight loss or retention, gestation week of delivery and infant birth weight in overweight, obese and morbidly obese women.
Project description:Pre-pregnancy overweight/obesity and excessive gestational weight gain (GWG) independently predict negative maternal and child health outcomes. To date, however, interventions that target GWG have not produced lasting improvements in maternal weight or health at 12-months postpartum. Given that interventions solely aimed at addressing GWG may not equip women with the skills needed for postpartum weight management, interventions that address health behaviors over the perinatal period might maximize maternal health in the first postpartum year. Thus, the current study leveraged a sequential multiple assignment randomized trial (SMART) design to evaluate sequences of prenatal (i.e., during pregnancy) and postpartum lifestyle interventions that optimize maternal weight, cardiometabolic health, and psychosocial outcomes at 12-months postpartum. Pregnant women (N?=?300; ?16?weeks pregnant) with overweight/obesity (BMI???25?kg/m2) are being recruited. Women are randomized to intervention or treatment as usual on two occasions: (1) early in pregnancy, and (2) prior to delivery, resulting in four intervention sequences. Intervention during pregnancy is designed to moderate GWG and introduce skills for management of weight as a chronic condition, while intervention in the postpartum period addresses weight loss. The primary outcome is weight at 12-months postpartum and secondary outcomes include variables of cardiometabolic health and psychosocial well-being. Analyses will evaluate the combination of prenatal and postpartum lifestyle interventions that optimizes maternal weight and secondary outcomes at 12-months postpartum. Optimizing the sequence of behavioral interventions to address specific needs during pregnancy and the first postpartum year can maximize intervention potency and mitigate longer-term cardiometabolic health risks for women.
Project description:OBJECTIVE:Evaluate whether a tailored letter improved gestational weight gain (GWG) and whether GWG mediated a multicomponent intervention's effect on postpartum weight retention among women with gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS:A cluster-randomized controlled trial of 44 medical facilities (n = 2,014 women) randomized to usual care or a multicomponent lifestyle intervention delivered during pregnancy (tailored letter) and postpartum (13 telephone sessions) to reduce postpartum weight retention. The tailored letter, using electronic health record (EHR) data, recommended an end-of-pregnancy weight goal tailored to prepregnancy BMI and GWG trajectory at GDM diagnosis: total GWG at the lower limit of the IOM range if BMI ?18.5 kg/m2 or the midpoint if <18.5 kg/m2 and weight maintenance if women had exceeded this. The outcomes for this study were the proportion of women meeting the Institute of Medicine (IOM) guidelines for weekly rate of GWG from GDM diagnosis to delivery and meeting the end-of-pregnancy weight goal. RESULTS:The tailored letter significantly increased the proportion of women meeting the IOM guidelines (72.6% vs. 67.1%; relative risk 1.08 [95% CI 1.01-1.17]); results were similar among women with BMI <25.0 kg/m2 (1.07 [1.00-1.15]) and ?25.0 kg/m2 (1.08 [0.98-1.18]). Thirty-six percent in the intervention vs. 33.0% in usual care met the end-of-pregnancy weight goal (1.08 [0.99-1.18]); the difference was statistically significant among women with BMI <25.0 kg/m2 (1.28 [1.05-1.57]) but not ?25.0 kg/m2 (0.99 [0.87-1.13]). Meeting the IOM guidelines mediated the effect of the multicomponent intervention in reducing postpartum weight retention by 24.6% (11.3-37.8%). CONCLUSIONS:A tailored EHR-based letter improved GWG, which mediated the effect of a multicomponent intervention in reducing postpartum weight retention.
Project description:The influence of childbearing in the development of obesity is situated within two different but related contexts: pregnancy-related weight gain and weight gain prevention and control in young adult women. Pregnancy related weight gain contributes to long-term weight retention in childbearing women.To present the study design, data collection procedures, recruitment challenges, and the baseline characteristics for the eMoms of Rochester study, a randomized clinical trial testing the effect of electronically-mediated behavioral interventions to prevent excessive gestational weight gain (GWG) and postpartum weight retention among women aged 18-35 years of diverse income and racial/ethnic backgrounds in an urban setting.Randomized double blind clinical trial. A total of 1722 women at or below 20 weeks of gestation were recruited primarily from obstetric practices and randomized to 3 treatment groups: control arm; intervention arm with access to intervention during pregnancy and control at postpartum (e-intervention 1); and intervention arm with access to intervention during pregnancy and postpartum (e-intervention 2). Enrollment and consent were completed via study staff or online. Data were collected via online surveys, medical charts, and measurement of postpartum weights. The primary endpoints are gaining more weight than recommended by the Institution of Medicine guidelines and weight retained at 12 months postpartum.This study will provide evidence on the efficacy of behavioral interventions in the prevention of excessive GWG and postpartum weight retention with potential dissemination to obstetric practices and/or health insurances. ClinicalTrials.gov #NCT01331564.
Project description:Background:Excess gestational weight gain (GWG) in pregnant adolescents is a major public health concern. Excess GWG increases risk of pregnancy complications as well as postpartum and offspring obesity and cardiometabolic disease. Prevention interventions for pregnant adults that target lifestyle modification (i.e., healthy eating/physical activity) show insufficient effectiveness. Pregnant adolescents have distinct social-emotional needs, which may contribute to excess GWG. From an interpersonal theoretical framework, conflict and low social support increase negative emotions, which in turn promote excess GWG through mechanisms such as overeating and physical inactivity. Methods:The current manuscript describes the design of a pilot randomized controlled feasibility trial of adolescent interpersonal psychotherapy (IPT) to address social-emotional needs and prevent excess GWG. Up to 50 pregnant, healthy adolescents 13-19y, 12-18?weeks gestation are recruited from an interdisciplinary adolescent maternity hospital clinic and randomized to IPT + usual care or usual care alone. IPT involves 6 individual 60-minute sessions delivered by a trained behavioral health clinician during 12-30?weeks gestation. Sessions include relationship psychoeducation, emotion identification and expression, and teaching/role-playing communication skills. Between sessions, adolescents are instructed to complete a daily journal and to have conversations to work on relationship goals. Outcomes are assessed at baseline, mid-program, post-program, and 3-months postpartum. Primary outcomes are feasibility and acceptability based upon rate of recruitment, session attendance, program acceptability ratings, and follow-up retention. Secondary outcomes are perinatal social functioning, stress, depression, and eating behaviors assessed with validated surveys and interviews; perinatal physical activity and sleep measured via accelerometer; GWG from measured weights; and at 3-months postpartum only, maternal adiposity by dual energy x-ray absorptiometry, maternal insulin sensitivity derived from 2-hour oral glucose tolerance testing, and infant adiposity by air displacement plethysmography. Discussion:This pilot trial will address a key gap in extant understanding of excess GWG prevention for a high-risk population of adolescents. If feasible and acceptable, brief psychotherapy to address social-emotional needs should be tested for its effectiveness to address excess GWG and postpartum maternal/infant health. If effective, such an approach has potential to interrupt an adverse, intergenerational cycle of social-emotional distress, obesity, and cardiometabolic disease among young mothers and their offspring. Trial registration:ClinicalTrials.gov NCT03086161, retrospectively registered.
Project description:<h4>Objectives</h4>To examine the patterns of fat mass gain in pregnancy and fat loss in the early postpartum period relative to women's pre-pregnancy body mass index (BMI) and by adherence to Institute of Medicine's gestational weight gain (GWG) recommendations.<h4>Design</h4>Prospective cohort study with three to four study visits.<h4>Setting</h4>This study is a part of the prospective longitudinal birth cohort, 'The Alberta Pregnancy Outcomes and Nutrition Study' (APrON) that recruited pregnant women from the cities of Edmonton and Calgary in Alberta.<h4>Participants</h4>1820 pregnant women were recruited and followed through their pregnancy and at 3?months postpartum.<h4>Outcome measures</h4>Body weight and skinfold thicknesses were measured during pregnancy and early postpartum in women. Body density was calculated from sum of skinfold thickness (biceps, triceps, subscapula and suprailiac), and total fat mass accretion during pregnancy was calculated using Van Raaij's equations and at postpartum using Siri's equation. Differences in total fat mass gain, fat mass loss and fat retention according to pre-pregnancy BMI categories and GWG categories were tested using two-way analysis of variance and post hoc comparisons.<h4>Results</h4>Most women (64%) had a normal pre-pregnancy BMI, and overall 49% women exceeded the GWG recommendations. Obese women gained significantly less total fat mass, had lower fat mass loss and had lower postpartum fat retention than normal-weight women (p<0.05). Women with excessive GWG gained higher total fat mass and had higher postpartum fat mass retention (p<0.03) than women who met the GWG recommendations. Total GWG was positively correlated with total fat gain (r=0.61, p<0.01) and total fat retention (r=0.31, p<0.05).<h4>Conclusion</h4>Excessive GWG is the significant risk factor for higher fat mass accretion during pregnancy and higher postpartum fat retention, irrespective of pre-pregnancy BMI.
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.