Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial

Linda Reme Sagedal 0 1 Nina C verby 2 Hilde Lohne-Seiler 2 Elling Bere 0 2 Monica K Torstveit 2 Tore Henriksen 3 Ingvild Vistad 0 1 0 Research Department, Sorlandet Hospital , Kristiansand , Norway 1 Department of Obstetrics and Gynecology, Sorlandet Hospital , Kristiansand , Norway 2 Department of Public Health , Sports and Nutrition , University of Agder , Kristiansand , Norway 3 Department of Obstetrics and Gynecology, Oslo University Hospital , Oslo , Norway Background: The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled with exercise classes compared with standard prenatal care. The aims of the study are to examine the effect of the intervention on maternal weight gain, newborn birth weight, glucose regulation, complications of pregnancy and delivery, and maternal weight retention up to 12 months postpartum. Methods/design: Fit for Delivery is a randomized controlled trial that will include 600 women expecting their first child. To be eligible, women must be 18 years of age or older, of less than 20 weeks gestational age, with a singleton pregnancy, and have a Body Mass Index (BMI) 19 kg/m2. The women will be randomly allocated to either an intervention group or a control group. The control group will receive standard prenatal care. The intervention group will, in addition, receive nutritional counseling by phone, access to twice-weekly exercise sessions, and information on healthy eating and physical activity provided in pamphlets, evening meetings and an interactive website. Both groups will be monitored by weighing (including bioimpedance measurements of percent body fat), blood tests, self-report questionnaires and hospital record review. Discussion: Weight gained in pregnancy affects the health of both the mother and her unborn child, and simple models for efficient intervention are in high demand. The Fit for Delivery intervention provides concrete advice on limiting energy intake and practical training in increasing physical activity. This lifestyle intervention is simple, reproducible, and inexpensive. The design of the study reflects the realities of clinical practice, where patients are free to choose whether or not they respond to health initiatives. If we find measurable health benefits associated with the intervention, it may be an easily adopted supplement to routine prenatal care, in the prevention of obesity. Trial registration: ClinicalTrial.gov, NCT01001689 - Background The health consequences of overweight and obesity have resulted in an increased interest in maternal weight gain during pregnancy. Several authorities, including the World Health Organization, have concluded that preventive efforts among pregnant women are required to make a long-term effect on the obesity epidemic [1,2]. The American Institute of Medicine (IOM) first suggested guidelines for weight gain during pregnancy in 1990, based on a womans pre-pregnancy BMI [3]. Specifically, it recommended that normal weight women (BMI 19.8-26 kg/m2) gain 11.5-16 kg, underweight women (BMI < 19.8 kg/m2) gain 12.5-18 kg, overweight women (BMI 26.1-29 kg/m2) gain 711.5 kg, and obese women (BMI > 29 kg/m2) gain at least 6.8 kg. Research suggests that weight gain at or below these recommendations is associated with an optimal delivery outcome for both mother and child [4,5]. These guidelines were modified in 2009, and the BMI ranges now correspond with WHO definitions of normal weight (18.5-24.9 kg/m2), underweight (<18.5 kg/m2) and overweight (2529.9 kg/m2), and the recommended weight gain for obese women is now 59 kg [6]. The effects of excessive gestational weight gain For the pregnant woman, excessive gestational weight gain is associated with an increased risk of complications during the prenatal period, such as gestational diabetes, gestational hypertension, and pre-eclampsia, a potentially life-threatening combination of hypertension and increased renal excretion of protein [5]. At the time of delivery, maternal overweight is associated with an increased incidence of complications, such as operative vaginal delivery, shoulder dystocia, cesarean section, and postpartum hemorrhage [7]. Excessive weight gain during pregnancy is also associated with an increased risk of weight retention after delivery [8]. In studies of obese women, as many as 73% describe pregnancy as an important trigger for a significant (>10 kilo) increase in weight [9]. Excessive gestational weight gain may also be a risk factor for the development of disease later in life, such as diabetes, hypertension, and breast cancer [10]. Excessive gestational weight gain is clearly associated with an increased incidence of large for gestational age babies [4] and has been linked with an increased incidence of overweight in childhood [11]. The large for gestational age newborn is at increased risk of birth trauma, respiratory distress syndrome, hypoglycemia, hyperbilirubinemia and admission to the neonatal intensive care unit, compared to newborns of appropriate weight [12]. Later in life, high birth weight is associated with an increased risk of overweight and obesity, along with diabetes and certain forms of cancer [13,14]. The effect of maternal weight gain on pregnancy outcome and fetal growth is at least partly moderated by maternal glucose levels. Maternal energy intake has a direct effect on serum glucose, while exercise moderates serum glucose levels by increasing skeletal muscle glucose uptake and improving insulin sensitivity [15]. Maternal plasma glucose levels have been shown to have a linear correlation with newborn birth weight [16] and the incidence of caesarean section [17]. Maternal glycemia has a direct correlation with fetal blood levels of insulin and c-peptide, which in turn regulate the growth of the fetus. Maternal dietary intake and physical activity level also have an influence on fetal levels of hormones such as leptin [18] and insulin-like growth hormone [19], the development of the fetal hypothalamus[20], the proportion of lean and fat body mass, and even gene expression [21]all of which will affect fetal growth and energy regulation later in life. The current literature on interventions to limit gestational weight gain Several recent review articles have summarized the current literature regarding interventions to limit weight gain in pregnancy [22-26]. Muktabhant et al. (2012) for the Cochrane collaboration [26] examined the results of a total of 27 randomized controlled trials, and divided interventions into those which recruited women from a general population and t (...truncated)