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5 Session 3: Implementing the Guidelines Patrick Catalano, an obstetrician and maternalâfetal medicine spe- cialist at Case Western Reserve University and a member of the Commit- tee to Reexamine IOM Pregnancy Weight Guidelines and of the Com- mittee on Implementation of the IOM Pregnancy Weight Gain Guide- lines, introduced the next session of the workshop. This session focused on federal, research, and private-sector perspectives on putting the Insti- tute of Medicine (IOM) pregnancy weight gain guidelines into action. The three panelists and one speaker for this session were ï· Marta Kealey, a nutritionist with the Supplemental Food Pro- grams Division at the Food and Nutrition Service (FNS) of the U.S. Department of Agriculture (USDA). ï· Michelle Lawler, deputy director of the Division of State and Community Health in the Health Resources and Services Admin- istration (HRSA). ï· Suzanne Phelan, associate professor of kinesiology, California Polytechnic State University. ï· Mr. Richard Sass, chairman of Contact Wellness Foundation. MARTA KEALEY, FOOD AND NUTRITION SERVICE, USDA FNS is responsible for all of the domestic nutrition assistance pro- grams in the United States, including the Supplemental Nutrition Assis- tance Program (formerly known as food stamps) and an array of other 41
42 DISSEMINATION OF THE PREGNANCY WEIGHT GAIN GUIDELINES nutrition assistance programs. The Supplemental Food Programs Divi- sion in FNS administers the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), which, according to 2010 data, provides services to about 40 percent of all women who deliver live births in the United States and to almost half of all infants born in the United States. About half of all pregnant WIC participants enter the program during their first trimester. Another 35 percent enter in their second trimester, while less than 10 percent enter in their third trimester. The program en- courages women to enroll early. WIC provides a defined list of supplemental foods that supply spe- cific nutrients of importance to pregnant and breastfeeding women, in- fants, and young children. In addition, WIC provides nutrition services, including nutrition assessment, nutrition education, referral to health and social services, promotion of physical activity, and an extensive breast- feeding promotion, support, and peer counseling program. As part of WICâs routine certification process, all women are weighed and meas- ured in the prenatal and postpartum periods. WIC has few federal re- quirements in terms of what health data it collects, but certain anthro- pometric data are required and are measured at the clinic. During their postpartum periods, women on WIC are periodically weighed and measured. WIC is unique among federal programs in that it continues services through the postpartum periodâfor 6 months if a woman is not breast- feeding and for an entire year if she is. This feature is part of WICâs ef- fort to encourage breastfeeding. The IOM pregnancy weight gain guidelines were very useful to WIC because the program relies on other professions and experts in the field to provide guidance on how to evaluate and assess appropriate precon- ception weight and maternal weight gain. When the 2009 IOM report was published, WIC changed its policy and practices. As of October 2011, all WIC clinics across the country and in the U.S. territories use the 2009 IOM weight gain guidelines in assessing and monitoring wom- en. WIC also included the weight gain guidelines in its WIC participant fact sheet, âTips for Pregnant Moms.â As part of its focus on periconception health care, WIC has funded a WIC periconception nutrition grants program in partnership with the University of California, Los Angeles, which awarded seven research grants under this program in the fall of 2012. The grantees will each partner with a local WIC agency to examine such topics as the impact of a short interpregnancy interval and weight retention, maternal over-
SESSION 3 43 weight and obesity, and innovative nutrition education interventions. The findings will be presented in 2016. MICHELE LAWLER, MATERNAL AND CHILD HEALTH BUREAU, HRSA HRSA is the primary federal agency tasked with improving access to health care services for people who are uninsured, isolated, or medically vulnerable. The agency has 6 bureaus and 10 offices. Two of the bureaus have particular relevance to the work of the Committee on Implementa- tion of the IOM Pregnancy Weight Gain Guidelines: the Maternal and Child Health Bureau (MCHB), which is primarily focused on the deliv- ery of core public health services, and the Bureau of Primary Health Care (BPHC), which oversees community health centers and is more focused on the delivery of primary care. Programs within both bureaus provide significant opportunities for encouraging the implementation of the 2009 guidelines. MCHB has a longstanding history of involvement in maternal nutrition and perinatal health, including having provided funding support to the IOM for the development of nutrition reports as far back as the 1970s. MCHBâs largest program, in terms of funding dollars, is the Mater- nal and Child Health Block Grant program, which was authorized under Title V of the Social Security Act. The program provides formula block grants to states that are awarded annually, with the amounts based partly on the number of children in poverty within a given state versus the number of children in poverty nationally. The block grants support a range of services in the states that are designed to ensure the health of the nationâs mothers, infants, and children, including children with special health care needs. In fiscal year 2011, the 59 states and jurisdictions in the program served more than 44 million individuals, including more than 2.3 million pregnant women. Over the years, national and state leadership provided by Title Vâsupported programs has contributed to implementing recommended standards for prenatal care and for im- proved nutritional practices during pregnancy. The states are also ex- pressing a growing interest in applying the life-course perspective to ma- ternal and child health practice. In addition to national performance measures and indicators on which states report annually, states develop between 7 and 10 state per- formance measures to address individual priority needs to the extent that they are not addressed by the national measures. Twenty-six such measures specifically focus on the weight status of women before, dur-
44 DISSEMINATION OF THE PREGNANCY WEIGHT GAIN GUIDELINES ing, and after pregnancy. Some states choose to focus their measures on weight status in women of reproductive age, whereas other states focus on the pre-pregnancy body mass index (BMI) in women who have given birth. Some states, such as North Carolina, focus on appropriate weight gain during pregnancy. State Title V programs are active in a number of areas: California considers obesity in its risk factor analysis for pregnancy-associated mor- tality reviews. It monitors pre-pregnant weight status and pregnancy weight gain based on the revised IOM guidelines. South Dakota is im- plementing a gestational weight gain initiative that provides materials and a toolkit on adequate pregnancy weight gain to physicians attending births across the state. Virginia has launched its Pregnancy Weight Gain Guidelines, a set of continuing education modules developed through a partnership with the University of Virginia. The Kentucky Department of Health provides annual training to local health department nurses and staff, including training on the IOM pregnancy weight gain guidelines. Wyoming focuses on helping women gain enough weight during preg- nancy in its Healthy Baby Is Worth the Weight program. MCHBâs Healthy Start program, which was initiated in 1991, pro- vides grants to communities with very high rates of infant mortality (at least 1.5 times the national average). The program focuses on reducing the factors that influence perinatal trends in high-risk communities. These projects are community driven and service focused. In 2010, 104 Healthy Start projects were providing services in 38 states, the District of Columbia, and Puerto Rico. Healthy Start projects provide risk-reduction and risk-prevention counseling on a range of issues. Prenatal program participants receive counseling on overweight and obesity, underweight, and gestational diabetes. Interconception participants receive counseling around overweight and obesity, underweight, lack of physical activity, and diabetes. Another new MCHB initiative is the Collaborative Improvement and Innovation Network (CoIIN) to reduce infant mortality. Born out of a January 2012 infant mortality summit convened in the 13 southern states, CoIIN was inaugurated in March 2012 as a mechanism to support the adoption of collaborative learning and quality improvement principles and practices to reduce infant mortality and improve birth outcomes. Strategy teams are working collaboratively on common priority areas identified in the individual state infant mortality action plans to establish quality improvement aims and to explore state-level opportunities for achieving the aims. The teams are currently developing measurements for tracking their progress, and most should finish their work by the end
SESSION 3 45 of 2013. Of particular interest to the Committee on Implementation of the IOM Pregnancy Weight Gain Guidelines may be the strategy team that is focusing on expanding interconception care in Medicaid. CoIIN is part of a portfolio of efforts from MCHB to improve birth outcomes, and it contributes to the advancement of the Department of Health and Human Services (HHS) Secretary Kathleen Sebeliusâs na- tional strategy for addressing infant mortality. It promotes increased sharing of best practices across the states, and it is strengthening existing collaborations between states in addressing maternal and child health issues of mutual concern. In 2013 the program will be expanded to in- clude the eight remaining HHS regions, beginning with Region V (Illi- nois, Indiana, Michigan, Minnesota, Ohio, Wisconsin). The National Maternal Health Initiative, described by Michael Lu and planned for launch in May 2013, is a publicâprivate partnership that is just getting under way. Work groups have been formed to identify best practices in quality of care, community efforts, womenâs health and pub- lic awareness, and surveillance. BPHCâs Health Center Program reached about 20.2 million patients in calendar year 2011. These patients, who were served by more than 138,000 staff members, had 80 million individual visits. Slightly more than 50 percent of the female patients were between the ages of 24 and 39 years. Of the total number of patients served, 41 percent were white non-Hispanic, 31 percent Hispanic, and 21 percent black non-Hispanic. Although the health centersâ uniform data system has no measures spe- cific to pregnancy weight gain, a few are somewhat related to pregnancy weight gain, such as the percentage of early entry into prenatal care and the percentage of newborns below normal birth weight. BPHC actively promotes a culture of quality improvement. Its strat- egies include the development and enhancement of access points to transform health care, particularly the adoption and meaningful use of electronic health records and the implementation of the patient-centered medical home, which together can serve to integrate health center pro- grams into other community services and align these services to promote quality health care (see Figure 5-1). In particular, goals 2 and 3 relate to areas that present real opportuni- ties for moving forward on the implementation of the pregnancy weight gain guidelines. Although the uniform data system and meaningful use do not include clinical performance measures specific to gestational weight gain, they do have measures concerning screening, BMI, and fol- low-up. Focusing on follow-up, screening, and counseling related to BMI
46 DISSEMINATION OF THE PREGNANCY WEIGHT GAIN GUIDELINES Health Center Program: Quality Strategy Better Care | Healthy People & Communities| Affordable Care INTEGRATED Priorities & Goals HEALTH SYSTEM 1. Implementation of Quality Assurance/Quality Improvement (QA/QI) Systems All Health Centers fully implement their QA/QI plans 2. Adoption and Meaningful Use of Electronic Health Records INTEGRATED (EHRs) SERVICES All Health Centers implement EHRs across all sites & providers 3. Patient Centered Medical Home (PCMH) Recognition COMPREHENSIVE All Health Centers receive PCMH recognition SERVICES 4. Improving Clinical Outcomes All Health Centers meet/exceed HP2020 goals on at least one UDS clinical measure 5. Workforce/Team-Based Care ACCESS All Health Centers are employers/providers of choice and support team-based care 1 FIGURE 5-1 Health center program: Quality strategy. SOURCE: Lawler, 2013. gives health centers the opportunity to follow a woman across her life span, including during pregnancy. Clinical decision support through the electronic health record is also a way to enhance guidelines-based care. Triggers can be put in based on patient characteristics and the timing of the visits, which can help in tracking the implementation of guidelines. Many opportunities also exist relative to the patient-centered medical home. The patient-centered medical home is accessible, comprehensive, and patient centered, and it is delivered by a team of interdisciplinary providers. It also makes possible the measurement of performance through a systems-based approach. HRSA programs in both MCHB and BPHC offer many opportunities for reaching key audiences in order to promote the adoption of the guide- lines among providers and to educate women about their importance. HRSA considers broad dissemination of the guidelines to be essential to its efforts to inform women, health care providers, state Title V pro- grams, community health agencies, and others about the importance of women entering pregnancy within a normal BMI and achieving recom- mended weight gain during pregnancy. HRSAâs focus goes beyond ges-
SESSION 3 47 tational weight gain and includes the promotion of appropriate weight before, during, and after pregnancy. In addition, HRSA considers preconceptional and interconceptional counseling and full implementa- tion of the 2009 pregnancy weight gain guidelines to be important changes in the care that is provided to women. Finally, HRSA is commit- ted to continued research on effective interventions to promote healthy weight in women before and after pregnancy and to help women achieve weight gain during pregnancy that is within the recommended ranges. SUZANNE PHELAN, CALIFORNIA POLYTECHNIC STATE UNIVERSITY In considering ways to disseminate the IOM pregnancy weight gain guidelines, Phelan said, workshop participants face three large questions: One, do we know how to help women gain the recommended amounts of weight in pregnancy? Two, are we ready to translate the knowledge into action? Three, what should the future look like? Results from the Fit for Delivery study, a randomized controlled trial to prevent excessive weight gain in pregnant women, provide one answer to the first question. The study recruited 200 normal weight and 200 overweight and obese pregnant women, each of whom was assigned to either standard care or standard care plus a lifestyle modification treat- ment program. The intervention, which was low intensity, focused on gestational weight gain, healthy eating, moderate physical activity, be- havioral strategies, and motivation. Motivation was addressed in one face-to-face visit at the research center at the beginning of the study combined with weekly mailing of printed cards that challenged the wom- en to engage in a different health behavior each week. All of the women received three brief phone-based counseling sessions and additional phone intervention if they were gaining too much or not enough weight. The women also received weight gain graphs after each of their regularly scheduled prenatal visits so that they could see how their weight gain compared to the guidelines. All the data were collected before the 2009 IOM revised guidelines were published, so results were based on the 1990 guidelines. However, after the appearance of the revised guidelines, the data were re-analyzed according to those guidelines, and the results were the same. The studyâs results showed that the intervention appeared to prevent excessive weight gain in the normal-weight women but not in the over- weight and obese women. Fifty-two percent of the normal-weight wom- en who received standard care exceeded the weight gain recommended in
48 DISSEMINATION OF THE PREGNANCY WEIGHT GAIN GUIDELINES FIGURE 5-2 Results: Proportion of women exceeding IOM weight gain guide- lines. NOTE: *OR =.38 [0.20â0.87]; p = .003]. SOURCE: Phelan et al., 2011b, p. 776. Reprinted with permission from the American Society for Nutrition. the guidelines, while only 40 percent of those in the intervention group did; by contrast, the investigators saw no difference between the standard care and intervention groups in the percentages of overweight and obese women who exceeded the guidelines. The women had been recruited early in pregnancy (after 13 weeks of gestation on average). At recruit- ment, 56 percent of the normal weight and 68 percent of the overweight and obese women were already above the recommended rate of gesta- tional weight gain for that time in the pregnancy (see Figure 5-2). Another major finding was that once women had exceeded recom- mendations during pregnancy, few were able to return to a weight gain that was within the guidelines. This was seen across subgroups of weight status, both in the standard care and intervention groups. Once a woman had gained more than the recommended weight, only between 3 and 10 percent were able to get back to within the recommended weight gain rates. Although the intervention stopped at delivery, the study saw positive effects at 6 months postpartum in both the normal-weight and the over- weight and obese groups in terms of the percentage of women who had returned to their pre-pregnancy weight or less by 6 months postpartum. Among the normal-weight women, 35 percent of the intervention group returned to their pre-pregnancy weight compared with only 20 percent of
SESSION 3 49 FIGURE 5-3 Percentages of women who returned to their preconception weights (Â±0.9 kg) or below at 6 months postpartum. SOURCE: Phelan et al., 2011b, p. 777. Reprinted with permission from the American Society for Nutrition. the standard care group. Among the overweight participants, 25 percent of the intervention group versus only 17 percent of the standard care group returned to pre-pregnancy weight or below (see Figure 5-3). Thus, in addressing the first question of whether we know how to help women gain the recommended amount of weight during pregnancy, the results from Fit for Delivery indicate that a low-intensity behavioral intervention can help prevent excessive gestational weight gain in normal-weight women but not in the overweight and obese, and that such an intervention is not very effective in helping women who are exceed- ing guidelines get back within guidelines. This indicates that more inten- sive interventions may be necessary, both to help overweight and obese women in pregnancy and to help women who are exceeding to get back within the guidelines. The Fit for Delivery study is just one of a large number of studies with varying results. Many recent published reviews and meta-analyses have summarized the results of gestational weight gain intervention tri- als. The results and the conclusions of the reviews differ, with some con- cluding that lifestyle interventions in pregnancy may be effective, and
50 DISSEMINATION OF THE PREGNANCY WEIGHT GAIN GUIDELINES others finding no or inconsistent effects as well as inadequate study quality. In light of such uncertainty, it may be helpful to consider what works to help women manage their weight outside of pregnancy. Decades of randomized clinical trials have tested interventions to help non-pregnant women manage their weight. The strategies can be classified into three main classes according to how well they work: effective, moderately ef- fective, and not effective. The effective strategies include setting calorie goals, using structured meal plans or meal replacements, weight monitor- ing, high physical activity, behavioral strategies, and ongoing patientâ provider contact. Randomized clinical trials of lifestyle interventions in pregnancy that have used a combination of several of these strategies have generally found positive effects on reducing excessive gestational weight gain, while studies that have used fewer of the strategies have had mixed ef- fects or no effects. These results indicate that comprehensive programs that include calorie goals, weight monitoring, behavioral strategies, Lessons Learned from Weight Control in Non-Pregnant Populations? Phelan, Jankovitz, Hagobian, Abrams (2011, Womenâs Health) EFFECTIVE IF USED EFFECTIVE IN COMBINATION â¢ Calorie goals NOT EFFECTIVE â¢ Meal replacements â¢ Fat intake or specific â¢ Body image â¢ Weight monitoring foods â¢ Body acceptance â¢ High PA â¢ TV viewing â¢ Education alone â¢ Behavioral â¢ Physical activity â¢ Social support strategies â¢ Continued contact * Many modes effective (physician, group, individual, Internet) * Strong predictor of long-term success = initial success FIGURE 5-4 Lessons learned from weight control in non-pregnant populations. SOURCE: Phelan, 2013. Derived from Phelan et al., 2011a.
SESSION 3 51 ongoing contact, and physical activityâand for overweight and obese women, daily diet monitoring as wellâmight be effective in helping prevent excessive weight gain. Clearly, much more research needs to be done to explore and con- firm these findings, and a number of studies are under way. Currently, clinicaltrials.gov shows that 21 randomized clinical trials are testing dif- ferent lifestyle interventions in pregnancy. The second key question is: Are we ready to translate knowledge into action? It is important to note that efficacy is not the same as effec- tiveness, so what is studied in research centers may not translate, that is, may not be feasible or have the same effects in the community. However, in light of the promising activities already described by presenters and programs that are available to women to help prevent excessive weight gain, it is reasonable to predict that âreal-world programsâ will show that the same pattern as the efficacy trialsâthat is, the comprehensive pro- grams will be the ones that work. Summary of RCTs Phelan, et al 2011; Womenâs Health CALORIE MEAL WEIGHT DAILY BEHAVIOR ON- EFFECT GOALS PLAN MONITOR DIET STRATEGY GOING >1/MO MONITOR CONTACT Wolf et al. (2008) X X X X X YES Thompson et al. (2009) X X X X X YES Quinlivan et al. (2011) X X X X X YES Asbee et al. (2009) X X X X YES Polley et al. (2002) X X X MIXED Phelan et al. (2011) X X X MIXED Jeffries et al. (2009) X MIXED Guelinckx et al. (2010) X NO Hui et al. (2006) X X NO Jackson et al. (2011) X X NO Callaway et al. (2010) X X NO Rhodes et al. (2010) X X NO Althuizen, E. (2013) X NO FIGURE 5-5 Summary of randomized control trials. SOURCE: Phelan, 2013. Derived from Phelan et al., 2011a. Reprinted with permission from Future Medicine Ltd.
52 DISSEMINATION OF THE PREGNANCY WEIGHT GAIN GUIDELINES Regarding the third questionâWhat should the future look like?â several options can be considered: ï· Modify current prenatal approaches to reverse the current pattern of prenatal care visits. Currently, visits tend to be backloaded so that women are seen more frequently toward the end of pregnan- cy and less frequently in the beginning. Changing this approach so that women are seen more frequently at the beginning of pregnancy could be considered, especially in light of data show- ing that once women exceed weight gain guidelines, it is difficult to get them back within the recommendations. ï· Classify pregnancies in overweight and obese women as high risk. This might open the door for more intensive and frequent contact. ï· Remember normal-weight women. Given the link between ex- cessive weight gain in normal-weight women and their risk of obesity and overweight later in life, it is important to ensure that programs are also available for this group. Most of the ongoing research is targeting overweight and obese women in pregnancy, but programs to help normal weight women are also valuable. ï· Provide multidisciplinary training for practitioners in methods to prevent excessive gestational weight gain and in strategies that encompass the life-course approach. ï· Ensure financial coverage to support such programs. QUESTION-AND-ANSWER SESSION Catalano moderated the question-and-answer session following the presentations. He opened the discussion by asking about the accuracy of pre-pregnancy weights reported by Fit for Delivery study participants. Phelan replied that, contrary to her expectations, the reported weights were reasonably accurate. The study team compared self-reported pre- pregnancy weight and chart-abstracted measured weights, and the corre- lation was 0.96. Andrea Sharma stated that she is using data from the Pregnancy Risk Assessment Monitoring System to conduct analyses of serial measured weights during pregnancy. The analysis is showing that first trimester gains are much higher than the assumed five-pound range. She wondered what could be done to catch those women early, regardless of their BMI if they are already above the first trimester weight gain threshold, and get them into nutrition counseling. Phelan strongly agreed and stated that
SESSION 3 53 any effort to encourage women to begin prenatal care early would be useful. Lawler added that it is also important to keep high-risk popula- tions in mind and ensure that women in these populations also begin pre- natal care as soon as possible. One participant asked whether pregnancy weight gain should be treated like non-pregnancy weight gain, given that the same weight con- trol strategies are effective for both populations. Would programs such as Weight Watchers or other weight loss programs be acceptable for the pregnant population? Phelan replied that although the strategies can be applied to pregnancy, they are applied differently. A critical distinction is that weight loss is not the same as preventing excessive weight gain. Much still needs to be learned about weight gain in pregnancy, and al- though it may be possible to apply to pregnancy much of the work that has been done outside of pregnancy, it is still premature to conclude that the pregnant and non-pregnant populations could be treated in the same way. The participant then asked whether, if the outcome of pregnancy is determined in the first 3 months of pregnancy, then might it be possible to change the paradigm of prenatal care so that women are seen more often in the first trimester? Many women do not even begin prenatal care until after the first trimester. Phelan responded by saying that an even more critical issue is motivating women to figure out that they are preg- nant earlier and to obtain care sooner or, ideally, to begin working with their providers even before pregnancy. Lawler noted that for the state Title V programs, entry into prenatal care is one of the national measures on which states report. Many preg- nancies are not planned; therefore, trying to get women to engage in healthful behaviors before pregnancy and to enter the health care system early in pregnancy is a challenge. She added, however, that this is one area in which interconception counseling can be very helpful. Even if clinicians miss the first pregnancy, WIC and other programs that follow the mother and the child after birth provide opportunities for education to help prepare the mother for the next pregnancy. Kealey added that the WIC community looks at the postpartum period as the preconception period for the next pregnancy and that additional emphasis on that per- spective may be warranted. Another participant suggested that student health services at colleges and universities could be a useful channel for action. Young women al- ready are visiting the services to obtain contraception and for gynecolog- ical issues. An opportunity exists there to lay a solid foundation for help- ing young women think about their health care and reproductive health
54 DISSEMINATION OF THE PREGNANCY WEIGHT GAIN GUIDELINES over the long term. The participant also returned to the issue of an early first prenatal visit, noting that even if a woman wants to see her obstetri- cian very early in her pregnancy, many practices will not see her before 8 or 11 weeks. There may need to be a culture shift on the medical side to convince practices to see women at 8 weeks or even 6 weeks. Another possible entry point for interconception care is through primary care pro- viders, such as pediatricians and family practitioners, who may see post- partum women often in the context of well-child care. Catalano thanked the presenters for their remarks and the participants for a stimulating discussion. REFERENCES Lawler, M. 2013. Presentation at Leveraging Action to Support Dissemination of Pregnancy Weight Gain Guidelines: A Workshop. National Acade- mies, Washington, DC, March 1. Available at http://www.iom.edu/ Activities/Children/PregnancyWeightDissemination/2013-MAR-01.aspx (ac- cessed June 12, 2013). Phelan, S. 2013. Presentation at Leveraging Action to Support Dissemination of Pregnancy Weight Gain Guidelines: A Workshop. National Academies, Washington, DC, March 1. Available at http://www.iom.edu/Activities/ Children/PregnancyWeightDissemination/2013-MAR-01.aspx (accessed June 12, 2013). Phelan, S., K. Jankovitz, T. Hagobian, and B. Abrams. 2011a. Reducing exces- sive gestational weight gain: Lessons from the weight control literature and avenues for future research. Womenâs Health 7(6):641â661. Phelan, S., M. Phipps, B. Abrams, F. Darroch, A. Schaffner, and R. Wing. 2011b. Randomized trial of a behavioral intervention to prevent exces- sive gestational weight gain: The Fit for Delivery Study. American Journal of Clinical Nutrition 93:772â779.