International Journal of Obesity (2002) 26, 1494–1502 ß 2002 Nature Publishing Group All rights reserved 0307–0565/02 $25.00 www.nature.com/ijo PAPER Randomized controlled trial to prevent excessive weight gain in pregnant women BA Polley1, RR Wing1* and CJ Sims2 1 University of Pittsburgh, Pittsburgh, Pennsylvania, USA; and 2Magee Womens Hospital, Pittsburgh, Pennsylvania, USA BACKGROUND: The Institute of Medicine (IOM) recommends that normal-weight women (BMI (body mass index) of 19.8 – 26.0) gain 25 – 35 lb (11.4 – 15.9 kg) during pregnancy, and that overweight women (BMI of 26.1 – 29.0) gain 15 – 25 lbs (6.8 – 11.4 kg). A significant number of normal-weight women and an even greater proportion of overweight women exceed these guidelines, which increases postpartum weight retention and may contribute to the development of obesity. OBJECTIVE: To determine whether a stepped care, behavioral intervention will decrease the percentage of women who gain more than the IOM recommendation. DESIGN: Randomized controlled trial comparing a stepped-care behavioral intervention with usual care. Women (n ¼ 120) who had a BMI > 19.8, age > 18 and < 20 weeks gestation were recruited from a hospital-based clinic serving low-income women and randomized by race and BMI category to the intervention or control group. The intervention group received education about weight gain, healthy eating, and exercise and individual graphs of their weight gain. Those exceeding weight gain goals were given more intensive intervention. Women were followed through pregnancy to their first postpartum clinic visit. The main outcome measure was weight gain during pregnancy categorized as above the IOM recommendations vs below or within the IOM recommendations. RESULTS: The intervention significantly decreased the percentage of normal-weight women who exceeded the IOM recommendations (33 vs 58%, P < 0.05). There was a non-significant (P ¼ 0.09) effect in the opposite direction among overweight women (59% of intervention and 32% of control gained more than recommended). Postpartum weight retention was strongly related to weight gain during pregnancy (r ¼ 0.89). CONCLUSIONS: The intervention reduced excessive weight gain during pregnancy among normal weight women. International Journal of Obesity (2002) 26, 1494 – 1502. doi:10.1038=si.ijo.0802130 Keywords: pregnancy; prevention of obesity; weight gain; randomized controlled trial; behavioral intervention Introduction The Institute of Medicine (IOM) recommends that normalweight women (BMI (body mass index) 19.8 – 26.0 kg=m2) gain 25 – 35 lb (11.4 – 15.9 kg) during pregnancy, and that overweight women (BMI 26.1 – 29.0 kg=m2) gain 15 – 25 lb (6.8 – 11.4 kg). Weight gains within these guidelines are associated with healthy fetal and maternal outcomes; weight gains below these goals are associated with low infant birthweight and higher weight gains are associated with macrosomia in the infant.1,2 Moreover, women who gain more than recommended retain twice as much weight after pregnancy as women who gain within the *Correspondence: RR Wing, Brown University=Miriam Hospital, Weight Control and Diabetes Research Center, 14 Third Street, Providence, RI 02906, USA. E-mail: rwing@lifespan.org Received 10 January 2002; revised 30 April 2002; accepted 24 May 2002 recommendations.3,4 For example, in the National and Maternal Health Survey, white women who gained above the IOM recommended level retained 2.2 kg at 10 – 18 months postpartum, whereas those who gained within the IOM recommendation retained only 0.7 kg. African American women who exceeded the recommended level of weight gain retained 5.8 kg, whereas those who gained within the recommended levels retained 3.3 kg.3 Weight gain during pregnancy may thus contribute to the development of obesity in young women. Although current weight gain goals are more liberal than in the past, a significant proportion of pregnant women exceed these current goals.3,5 Based on data from the National Maternal and Infant Health Survey, which includes a representative sample of women in the United States who had live births in 1988, 36% of women exceed the IOM recommendations. Only 20% of underweight women exceeded these goals, but 37% of normal-weight women Prevention of excessive weight gain in pregnancy BA Polley et al 1495 and 64% of overweight women gained more than recommended.3 Similarly, in a study of over 4000 women from the University of California, San Francisco Perinatal Database, 23% of underweight women, 49% of normal-weight women, and 70% of overweight women exceeded the recommendations.5 Thus a substantial proportion of normal-weight women and an even greater proportion of overweight women gain more than is recommended. Weight gain during the first 20 weeks of gestation has been shown to be predictive of total weight gain;6 – 8 thus, it may be possible to identify women early in pregnancy who will exceed the weight gain guidelines and counsel them about healthy eating and exercise habits to prevent excessive weight gain during pregnancy. This approach fits with the Subcommittee on Weight Gain of the National Academy of Science’s recommendation that deviations from the desired rate of weight gain be discussed with the woman and corrective actions such as ‘moderating consumption and increasing physical activity’ be initiated, as appropriate.1 However, no studies to date have examined the efficacy of providing education and behavioral strategies related to healthy eating, moderate exercise and appropriate weight gain goals as a means of helping women achieve appropriate rates of pregnancy weight gain. The goal of the present study was to develop and test a stepped care behavioral intervention to reduce excessive weight gain during pregnancy. The intervention provided education and feedback about weight gain, and stressed modest exercise and healthy, low-fat eating. We examined whether, compared with a usual care control group, the intervention would reduce the number of women who exceed the IOM recommendations. Because normal-weight and overweight women have different IOM weight gain goals and appear to differ in the proportion of women exceeding these goals, we examined the efficacy of the intervention for these two groups. All women signed a consent form approved by the Institutional Review Boards of the University of Pittsburgh Medical Center and Magee-Womens Hospital. Of the 120 women who entered the study, 110 (92%) were followed through the end of their pregnancy; three of the 120 women miscarried, six moved out of the area, and one asked to withdraw from the study. An additional five in the intervention group requested withdrawal from the study but gave consent for continued monitoring via record review and were retained for all analyses. The final sample of 110 women included 57 in the treatment group (30 normal weight, 27 overweight) and 53 in the control group (31 normal weight, 22 overweight). Analysis of variance and chi-square showed no differences between the treatment and control group on any of the demographic characteristics summarized in Table 1. Design and procedures Women were randomly assigned to the standard care control group or to the intervention stratified by BMI category (normal weight vs overweight) and self-reported race (black vs white). BMI was based on retrospective self-reported height and weight at last menstrual period with normal weight defined as BMI ¼ 19.8 to 26.0 and overweight BMI > 26.0. Although the IOM recommends a weight gain of 6.8 – 11.3 kg for overweight women (BMI of 26.1 – 29) and a weight gain of 6.8 kg (with no specified upper limit) for obese women (BMI > 29), these two groups were collapsed in the present study and the recommendations for overweight women were used, as occurs in other research on this topic.5 Standard care Subjects in the standard prenatal care condition received only the standard nutrition counseling provided by the Table 1 Demographic characteristics Methods Participants Pregnant women were recruited before 20 weeks gestation (mean s.d. ¼ 14.5 3.1 weeks) from an obstetric clinic for low-income women at a hospital in Pittsburgh, PA, USA. Subjects were recruited into four cells: normal and overweight, black and white. Underweight women (BMI < 19.8 based on self-reported weight at height at the last menstrual period) were excluded, as were women younger than 18 y, those whose first prenatal visit was > 12 weeks gestation, and those with a high-risk pregnancy (ie drug abuse, chronic health problems, previous complications during pregnancy, or current multiple gestation). Of 164 women who were approached, 120 enrolled in the study. Refusal rates were higher among black women (28=74 refused) than among white women (16=90 refused), P < 0.005, and higher in overweight blacks (16=37 refused) than in any of the other three weight-by-race categories (P < 0.02). Variable Distribution Age (y) Mean ¼ 25.5 4.8 Race 39% black 61% white Marital status 31% married 14% separated, divorced or widowed 55% never married Education 45% high school or less 42% vocational training or some college 9% college graduate 4% graduate training Employment 57% unemployed 14% trade, service 16% clerical, sales 6% professional 7% other Childbearing history 47% first pregnancy 30% second pregnancy 17% third pregnancy 6% > third pregnancy International Journal of Obesity Prevention of excessive weight gain in pregnancy BA Polley et al 1496 physicians, nurses, nutritionists and WIC counselors at Magee-Womens Hospital. This counseling emphasized a well-balanced dietary intake and advice to take a multivitamin=iron supplement. No information or counseling was provided by the research staff. Intervention The intervention was delivered at regularly scheduled clinic visits by master’s and doctoral level staff with training in nutrition or clinical psychology. Shortly after recruitment, women in the intervention condition were given written and oral information in the following areas: (a) appropriate weight gain during pregnancy; (b) exercise during pregnancy; and (c) healthful eating during pregnancy. Newsletters prompting healthy eating and exercise habits were mailed biweekly. In addition, after each clinic visit, women in the intervention condition were sent a personalized graph of their weight gain. Women whose weight changes were within the appropriate ranges were informed that they were gaining the expected amount of weight and were encouraged to eat a healthy diet and to have a physically active lifestyle; those gaining too little were told to check with their physician for guidance outside the scope of this study. Women whose weight gains exceeded the recommended levels were given additional individualized nutrition and behavioral counseling using the format listed in Table 2. A steppedcare approach was used, where the woman was given increasingly structured behavioral goals at each visit if her weight continued to exceed the recommended levels. The primary focus of the dietary intervention was on decreasing high-fat foods, such as fast food items, and substituting healthier alternatives (fruit and vegetables); if these approaches did not help the woman achieve the IOM recommended weights, then a more structured meal plan and individualized calorie goals were added. The exercise intervention focused on increasing walking and developing a more active lifestyle (eg walking rather than driving short distances). Between clinic visits women were contacted by telephone to discuss progress towards the goals set at the previous visit. Measures Pre-pregnancy weight was the weight at the last menstrual period, as reported by the participant at the time of recruit- Table 2 Format of individual counseling sessions Review of weight gain chart Assessment of current eating and exercise (ie a 24 h recall or examination of self-monitoring records), with periodic computerized nutrition analysis Review of progress toward behavioral goals Problem-solving Instruction in the use of behavioral techniques such as stimulus control or self-monitoring Goal-setting for eating and exercise behaviors International Journal of Obesity ment into this study. Weight was measured at every clinic visit using a digital or balance beam scale. Total weight gain was based on self-reported pre-pregnancy weight and weight at the last clinic visit prior to delivery. For five women, the last clinic visit was more than one month prior to delivery and self-reported weight at delivery was used. Postpartum weight was obtained at the first clinic visit after delivery (mean s.d. ¼ 8 7.1 weeks); self-reported weight was used for 14 women; postpartum weight was unavailable for 36 women. Demographic and weight history information was obtained at recruitment. Self-report measures of dietary intake and exercise expenditure were obtained at recruitment, 30 weeks gestation, and 6 weeks postpartum. A short form of the Block Food Frequency Questionnaire,9 administered by interview, was used to assess consumption of 13 major contributors to fat intake over the past month. This questionnaire was included to examine changes in intake of high-fat foods rather than to try to describe the participants’ overall dietary consumption. Energy expenditure was measured using the Paffenbarger Exercise Questionnaire10 by interview, assessing stair-climbing, walking and recreational activities over the last week. Obstetric records were reviewed after delivery to obtain infant birth weight and complications during pregnancy and=or delivery. Statistical analysis The primary dependent variable was the proportion of women who exceeded the IOM recommendation. This was analyzed by logistic regression examining the effect of treatment group and BMI category on weight gain category (above IOM recommended level vs below IOM recommended level). Weeks of gestation at delivery was used as a covariate. Secondary aims were to assess the effects of treatment group and BMI category on total weight gain, weight gain from recruitment to delivery, postpartum weight loss and weight retention. Analysis of variance was used for these secondary aims; again weeks of gestation at delivery was used as a covariate. When significant interactions with weight category were observed, post hoc analyses were conducted to analyze the effects of treatment separately in normal-weight and overweight women. Because pre-pregnant weight differed in normalweight women in the control and intervention groups, prepregnancy weight was covaried in these post hoc analyses. Analyses were done using an intent-to-treat approach, including all participants available at the post-pregnancy or postpartum assessments (Figure 1). Both SAS and SPSS statistical packages were used. Results The flow of participants through the study is shown in Figure 1. Weight change variables are summarized in Table 3. Prevention of excessive weight gain in pregnancy BA Polley et al 1497 Figure 1 Flow of subjects. Excessive weight gain during pregnancy Initial analyses examined whether women met weight gain goals at any time during the pregnancy (ie whether the women’s weight gain ever exceeded the expected range), and whether they later ‘recovered’ (ie achieved weight gains within the expected range). As shown in Table 3, there was a significant interaction (P ¼ 0.01) between treatment group and BMI category for the percentage of women Table 3 who exceeded the IOM recommendations at some point during their pregnancy. Among normal-weight women, 94% of the control group exceeded the recommended level at some point during pregnancy compared with 63% of women in the intervention group, P < 0.05. Among overweight women, about two-thirds exceeded the recommended level at some point in their pregnancy regardless of treatment group, P > 0.4. Weight changes during pregnancy by treatment group and BMI category, mean s.d. or n (%) Normal-weight Overweight Control (n ¼ 31) Intervention (n ¼ 30) Control (n ¼ 22) Intervention (n ¼ 27) 22.5 2.0 59 6.9 22.8 1.9 62.1 6.1* 34.1 7.2 91.8 19.6 31.4 6.0 83.6 16.7b,c Exceeded IOM recommendations at some point during pregnancy, n (%) Recovery rates, n (%) 29 (93.5%) 19 (63.3%)* 14 (63.6%) 20 (74.1%) 11 (37.9%) 9 (47.4%) 7 (50.0%) 4 (20.0%) Total weight gain (kg) (range, kg) 16.4 4.8 (6.8 – 30.9) 15.4 7.1 (2.7 – 32.7) 10.1 6.2 (70.9 – 26.4) 13.6 7.2b (1.4 – 29.1) IOM categories of total weight gain Exceed IOM recommend, n (%) Mean gain (kg) Within IOM recommend, n (%) Mean gain (kg) Below IOM recommend, n (%) Mean gain (kg) 18 (58.1%) (19.1 kg) 8 (25.8%) (13.6 kg) 5 (16.1%) (9.5 kg) 10 (33.3%)* (23.6 kg) 11 (36.7%) (13.6 kg) 9 (30.0%) (8.2 kg) 7 (31.8%) (17.3 kg) 8 (36.4%) (10 kg) 7 (31.8%) (3.6 kg) 16 (59.3%)c (17.7 kg) 6 (22.2%) (10.5 kg) 5 (18.5%) (4.1 kg) Postpartum weight lossa Net weight retention, kga n ¼ 21 79.0 2.4 6.2 4.5 n ¼ 18 79.6 3.5* 4.4 5.4 2 Prepregnancy BMI (kg=m ) Prepregnancy weight (kg) a n ¼ 19 79.6 2.7 0.3 7.0 b c n ¼ 16 79.1 4.1 3.6 5.6 b Postpartum weights available for 74 participants and all postpartum weights adjusted for weeks postpartum; main effect of BMI category, P < 0.001; cinteraction between treatment group and BMI category, P < 0.01. *Indicates a significant treatment effect for post hoc analyses within each BMI category. International Journal of Obesity Prevention of excessive weight gain in pregnancy BA Polley et al 1498 Women in the intervention group who exceeded the weight gain pattern were notified that they were gaining above the IOM recommended levels and were provided with at least one additional counseling session. The number of additional sessions ranged from 1 to 11, depending on whether the women’s weight gain ‘recovered’ or remained above the guidelines. Of the intervention women who received additional sessions, normal-weight women received an average of 3.3 additional sessions and overweight women received an average of 4.8 additional sessions. As shown in Table 3, there was a trend for a significant treatment group-by-BMI category interaction in the proportion of women who were able to recover from excessive weight gain during pregnancy and go on to have a total weight gain within or below IOM recommendations, P ¼ 0.07. However, there was no significant effect of treatment when normal-weight and overweight women were analyzed separately (P > 0.1). Excessive total weight gain The primary goal of the intervention was to decrease the percentage of women who exceeded the IOM guidelines from pre-pregnancy to the end of pregnancy. As shown in Figure 2, there was a significant interaction between treatment group and BMI category for excessive weight gain, P < 0.01. Among normal-weight women, those in the intervention group were significantly less likely than controls to gain above the IOM recommendations, P < 0.05. Among overweight women, there was a non-significant effect of treatment, P ¼ 0.09, but the trend was in the opposite direction. There were no significant effects of race on the percentage of women with excessive weight gains, P > 0.3, nor did race interact with treatment group or BMI category. Weight gained before recruitment was strongly related to excessive weight gain, P < 0.0001 but none of the other demographic variables predicted excessive weight gain. Figure 2 Percentage of women whose total weight gain exceeded IOM recommendations. Overall BMI category by treatment interaction, P < 0.01; treatment effect among normal-weight women, P < 0.05; treatment effect among overweight women, P ¼ 0.09. International Journal of Obesity Figure 3 Pattern of weight gain at three timepoints: pre-pregnancy (self-reported), recruitment (mean ¼ 14 weeks), and delivery. The IOM recommends that overweight women gain 2 lb in the first trimester and 15 – 25 lb (6.8 – 11.4 kg) total, and normal-weight women gain 3.5 lb (1.6 kg) in the first trimester and 25 – 35 lb (11.4 – 15.9 kg) total. Continuous analysis of weight gain during pregnancy Although the intervention affected the percent of normalweight women who exceeded the weight gain goal, Figure 3 shows that the intervention had no significant effects on the average weight gain from pre-pregnancy to delivery (using self-reported pre-pregnancy weight) or on weight gain from recruitment to delivery. On average, normal-weight women gained 35.0 lb (15.9 kg) from pre-pregnancy to delivery and overweight women gained 26.5 lb (12.0 kg; P < 0.001). Weight gains were comparable in black and white women (31.4 vs 31.0 lb (14.3 vs 14.1 kg)). Weight gain from prepregnancy to delivery was related to pre-pregnancy weight (P < 0.05), weeks of gestation at delivery (P < 0.05) and the amount of weight gained before recruitment (P < 0.001), but was unrelated to any of the baseline demographic variables. Behavior changes during pregnancy At recruitment, fat consumption from 13 high-fat foods averaged 55.9 g per day. All groups decreased their fat consumption from these foods from baseline to 30 weeks, except normal-weight women in the control condition. There was no effect of treatment on changes in fat intake from these foods from recruitment to 30 weeks (P > 0.2), nor was there a significant treatment by BMI category interaction (P > 0.1). Twenty women were put on bed rest by their obstetricians; of these women, 11 were put on bed rest prior to the 30-week assessment and were omitted from the exercise analyses. Mean exercise expenditure at recruitment was 614 kcal=day (2570 kJ=day). There were no differences between groups in exercise levels at recruitment (P ¼ 0.059), but control women tended to be less active than women in the counseling condition. Changes in exercise level from recruitment to 30 weeks (P > 0.8) were not related to treatment condition or BMI. Moreover, collapsing across Prevention of excessive weight gain in pregnancy BA Polley et al 1499 treatment groups (n ¼ 110), neither dietary intake nor exercise level was related to the amount of weight gained during pregnancy nor to whether the women exceeded the IOM guidelines. Pregnancy complications and fetal outcomes Logistic regression was used to examine the effects of treatment on the percentage of women with low weight gain, controlling for pre-pregnancy weight and weeks of gestation at delivery. The percentage of women who gained less than recommended did not differ significantly for the intervention vs control group (P > 0.2), nor was the interaction between BMI category and treatment group (P > 0.2) significant. Pregnancy outcomes are displayed in Table 4. The number of obstetric complications was too small for statistical analysis, but does not appear to have been dramatically affected by the intervention. Similarly, there were no treatment by BMI category differences in infant birth weight, P > 0.8. Postpartum weight loss and weight retention Postpartum weights were available for 74 (67.3%) of the 110 women, who were weighed 8 7.1 (mean s.d.) weeks after delivery. Postpartum weights were compared with delivery weights to compute weight loss. The strongest predictor of postpartum weight loss was the number of weeks postpartum when weight was measured, P ¼ 0.002; therefore we controlled for weeks postpartum in all analyses of postpartum weight. As shown in Table 3, the average postpartum weight loss in each group was about 20 lb (9.1 kg), with no effect of BMI category or treatment group, nor a significant interaction (all P > 0.4). Mean postpartum weight retention (postpartum weight less pre-pregnancy weight) was 8.1 13.1 lb (3.7 5.9 kg), ranging from 722 to 37 lb (710 to 16.8 kg). Weight retention was strongly correlated with weight gain during pregnancy, r ¼ 0.89, P < 0.001. There was a trend for a significant interaction between treatment group and BMI category on weight retention (P ¼ 0.06), with normal-weight women in the intervention group retaining less than those in the control group (9.6 vs 13.7 lb; 4.4 kg vs 6.2 kg), and overweight women in the intervention group retaining more than those in the control group (7.9 vs 0.66 lb; 3.6 vs 0.3 kg); however, neither of these differences reached conventional levels of significance. Postpartum weight loss and weight retention were also analyzed by race. There was a significant race effect for postpartum weight loss (P ¼ 0.01), with black women losing less weight than white women, with losses of 17.8 and 22.1 lb (8.1 and 10.0 kg), respectively. However, there was no effect of race on weight retention (postpartum weight less pre-pregnancy weight), nor did race interact with BMI category or treatment group. Black and white women retained 9.5 and 7.3 lb (4.3 and 3.3 kg), respectively. Comment We developed a stepped care, behavioral intervention to reduce excessive weight gain during pregnancy. The intervention included education and behavioral strategies to promote healthy, low-fat eating, modest exercise and appropriate weight gain during pregnancy. We found the intervention was effective in reducing the frequency of excessive weight gain in normal-weight women; whereas 58% of normal-weight women in the control condition gained more than 35 lb (15.9 kg) during pregnancy, only 33% of normal-weight women exceeded this IOM guideline. The intervention had no significant effect among overweight women, but the trend was in the opposite direction. The effectiveness of the intervention among normalweight women appeared to be due primarily to the fact that fewer women in the intervention group than in the control group exceeded the expected amount of weight gain at any point during their pregnancy (63 vs 94%). Such prevention of excessive weight gain may have resulted from the basic education about healthy eating and exercise that was provided to all women in the intervention group and=or the individual weight graphs they received. There Table 4 Effect of treatment group and BMI category on pregnancy outcomes Normal weight Infant birth weight (g) Low birth weight (<2500 g), n Macrosomia (>4000 g), n Weeks gestation at delivery Preterm delivery (<36 weeks), n Cesarean delivery (n) Pre-eclampsia (n) Maternal hypertension (n) Gestational diabetes (n) Overweight Control (n ¼ 31) Intervention (n ¼ 30) Control (n ¼ 22) Intervention (n ¼ 27) 3226.4 3 0 3133.0 4 1 3349.0 2 0 3282.8 1 0 39.5 2 4 0 4 2 39.1 5 2 0 2 0 39.1 3 6 3 4 1 39.4 2 2 2 4 2 International Journal of Obesity Prevention of excessive weight gain in pregnancy BA Polley et al 1500 was a trend for the intervention to also help normal-weight women who exceeded the expected rate of weight gain ‘recover’ and achieve subsequent weight levels within the IOM guidelines, but this effect was not significant. Thus, the more intensive stepped-care intervention that occurred subsequent to excessive weight regain may have been a less effective component of the intervention than the prevention component. Since the more intensive stepped-care approach is the costly aspect of the intervention, further study of specific components of the intervention is needed. Whereas the intervention was effective in normal-weight women, there was a non-significant adverse trend among the overweight participants. This finding may in part be due to the low rate of excessive weight gain in the overweight control group in the present study. While previous studies suggest that about two-thirds of overweight women may exceed the IOM guidelines during pregnancy,3,5 only 32% of the overweight control group in this study exceeded this level. Of particular note is that only one of nine overweight black women (11%) in the control condition exceeded the weight gain goals. Since overweight black women were most likely to refuse entry into the study, those women who participated may not have been representative of this population. Alternatively, the lack of a treatment effect among overweight women may also be related to their longstanding difficulties with weight control, making a minimal intervention such as the program used here less effective, or to an unmeasured factor such as dietary restraint, which could lead to disinhibited overeating if the participants found the intervention stressful. The differential outcome for normal and overweight women may also again suggest that the intervention was more effective for preventing problems with weight gain than for treating these problems. Although non-significant, there was a tendency for normal-weight women in the intervention condition to gain less than recommended by the IOM. This raises concerns about possible adverse effects of the intervention. The study was clearly under-powered to examine pregnancy outcomes, but future research should carefully address the safety of the intervention. Previous studies suggest that on average women retain only a small amount of weight post-pregnancy, especially if potential confounders such as self-report of pre-pregnancy weight and the effect of aging are taken into consideration.11 In carefully controlled studies, post-pregnancy weight retention in North American women averaged 0.6 – 3.0 kg,12 and 1.4 – 1.6 kg;13 women in the Netherlands retained 1.4 kg14 and women in England retained 70.82 – 0.28 kg11 following their pregnancy. For a subgroup of women, however, weight gain during pregnancy may contribute to obesity.11,15 In the Stockholm Pregnancy and Weight Development Study, 73% of a sample of severely obese women reported that they maintained more than 10 kg after pregnancy.15 Over 50% of Americans are overweight or obese. Most obesity develops during adulthood and women aged 25 – 44 are at greatest risk of a major weight gain.16 These large weight gains and the International Journal of Obesity resulting development of obesity may relate in part to pregnancy weight gains. For example, in a study which followed over 1000 normal-weight women through two consecutive pregnancies, weight gains above the recommended level during the first pregnancy increased the risk of being overweight at the time of the second pregnancy three-fold.17 We found a very strong association (r ¼ 0.89) between weight gain in pregnancy and postpartum weight retention. Previous studies have likewise seen such an association with correlations ranging from 0.36 to 0.84.8,18 – 20 Moreover, in the present study, the effects of the intervention on postpartum weight retention paralleled the effects of the intervention on excessive weight gain in pregnancy. Specifically, there was a trend (P ¼ 0.06) for normal-weight women in the intervention group to retain less than those in the control group and for overweight women in the intervention group to retain more weight than those in the control. These findings support the importance of improving the effectiveness of our intervention for normal-weight women and developing a better approach for overweight women as a means of preventing large weight retention postpartum. Several limitations of the research and its findings should be noted. Most importantly, the sample size in this study may have limited our power to detect significant effects of the intervention. With a sample size of n ¼ 120, we had 0.75 power to detect a difference of 20% between the control and the intervention group in a one-sided chi-square (a ¼ 0.05), assuming that 45% of the control group exceeded the IOM guidelines. Power was limited further by the fact that only 110 of the 120 women completed the study and only 74 were available for postpartum measurements. Secondly, this study utilized a lower-income clinic population which faced many barriers to participation in the program, such as lack of social support (over half were single), financial hardship (over half were unemployed), and practical issues such as unreliable transportation for grocery shopping and access to health care and disruptions in phone service which interfered with maintaining contact with the study. Many of the women also faced issues such as smoking, alcohol and drug use, and coping with an unplanned pregnancy; this population (and their health care providers) had more critical concerns than the effect of excessive weight gain on maternal and infant health. These women had very limited knowledge about nutrition and healthful eating and needed intensive education and counseling; however, their limited resources (eg unreliable attendance at appointments) made intensive counseling difficult. Selecting a more adherent population would allow for a better test of the efficacy of behavioral intervention during pregnancy. The intervention used in this study was designed to minimize risk, and this may have limited its effectiveness. Participants were initially taught to make healthy, low-fat choices, but were not prescribed a specific diet or given a restricted energy intake goal until they had exceeded the Prevention of excessive weight gain in pregnancy BA Polley et al 1501 recommended weight at four consecutive clinic visits. Studies with GDM patients21 – 24 suggest that some energy restriction can be implemented safely during pregnancy, although the applicability of these findings to non-diabetic pregnancies is unclear. This study showed no differences between conditions in eating or exercise behavior, perhaps reflecting the limited changes that were obtained, the difficulty of accurately assessing these behaviors,25 and the limitations of the instruments selected for assessing diet and activity in the present study. Moreover, data were not collected on other behaviors that could potentially affect pregnancy-associated weight changes, including changes in smoking habits, breast feeding and general lifestyle changes accompanying pregnancy and motherhood.16 Like most pregnancy studies, we relied on a self-reported pre-pregnancy weight and for a few cases on self-reported postpartum weight. Several studies have suggested that such self-reports are quite accurate, typically underestimating weight by 1 – 2 kg.17 However, in one study of adolescents, there was more pronounced under-reporting among the overweight.27 Thus, self-reported pre-pregnancy weight is a possible source of error among overweight women, but should have affected the intervention and control condition equally. Weight gain during pregnancy was strongly correlated with pre-pregnancy weight and with weeks gestation at delivery. Given this tight biological control, it may be difficult to influence pregnancy weight gain by lifestyle changes. Indeed, studies of maternal nutritional supplementation during pregnancy have found minimal effects on weight gain, even when supplements of up to 1000 kcal per day are provided (with notably poor compliance).28,29 This biological drive, coupled with the numerous competing self-care demands during pregnancy, may limit the magnitude of change possible during pregnancy. Thus, a postpartum approach should also be considered. Lovelady and colleagues30 were able to promote weight loss in newly postpartum overweight women with a 10 week eating and exercise program, with no detrimental effects on lactation success, and Leermakers and colleagues31 found that a correspondence intervention was effective in promoting weight loss in postpartum women. However, during postpartum interventions, women are busy with infant care and adjustment to motherhood, which may limit the effectiveness of postpartum interventions. Perhaps the most effective approach would be to begin to educate women during pregnancy about healthy eating and exercise and attempt to limit the frequency and extent of excessive pregnancy weight gain, and then continue such interventions in the postpartum period for those who have retained excessive amounts of weight. Our conservative intervention significantly reduced excessive weight gain among normal-weight women but not among overweight women. Given that the majority of childbearing women are normal weight, and that our results were achieved in a low-SES population with considerable barriers, this intervention shows promise as a behavioral method of promoting appropriate weight gain during pregnancy, and helping to prevent the development of long-term weight problems. Further research is needed to confirm the efficacy and safety of this type of behavioral intervention for preventing excessive weight gain in normal-weight women and to define the key components of the intervention that are required for its success. In addition, it is important to develop a more effective way to prevent excessive pregnancy-related weight gain in overweight women. Acknowledgments We wish to thank Cathy DeBranski, RN-C for her help in recruiting and scheduling participants for this study. This work was funded by a grant from Magee-Womens Health Foundation; Magee-Womens Research Institute awarded to Dr Wing. References 1 Lederman SA. 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