February 19, 2016
Attn: Center for Disease Control and Prevention Desk Officer
Office of Management and Budget
Washington, DC 20503
Re: Balance after Baby Intervention—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC)
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to comment on the Center for Disease Control and Prevention's proposed information collection project, entitled Balance after Baby Intervention: Phase 2 (BABI2). Representing over 90,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States committed to improving the nation's health through food and nutrition across the lifecycle. Academy members provide professional services such as medical nutrition therapy (MNT)2 and were involved in the development, implementation, and provision of the National Diabetes Prevention Program (NDPP) from the very beginning. We look forward to continuing to work with CDC on this new iteration of the NDPP to ensure that it also is scalable, sustainable, and effective in preventing gestational diabetes throughout the country.
The Academy supports the proposed collection of information as necessary for the proper performance of the intervention, and we offer the following substantive comments. We recommend that screening and follow-up occur at earlier time frames than suggested, in order to improve health outcomes. We also recommend that CDC expand the number of participants in the proposed project and ensure that diverse populations are included. We encourage CDC to consider including evidence-based interventions provided by qualified health professionals, including RDNs, in the proposed intervention framework. We offer more details below, which would enhance the quality and utility of the information to be collected in the proposed intervention and reduce the burden of gestational diabetes in the US.
I. Need for Cost-Effective and Clinically-Effective Gestational Diabetes Care
The Academy recognizes the vast human and economic burden of gestational diabetes mellitus (GDM). The most recent data indicate that as many as 1 in 11 pregnant women have GDM, with many more potentially unreported.3 Shortly after pregnancy, 5 to 10 percent of women are diagnosed with type 2 diabetes,4 while 35 to 60 percent are diagnosed in the next 10 to 20 years.5 With 13.4 million women in the country over the age of 20 diagnosed with diabetes, and the increasing prevalence of diabetes in the U.S.,6 the detection and treatment of GDM can help prevent the health and economic costs associated with diabetes.
The health consequences of GDM and its comorbidities are staggering. GDM can cause macrosomia, shoulder damage, very low blood glucose levels, and breathing problems at birth and increased risk for obesity and type 2 diabetes later in life. Many pregnant women with GDM diagnosed during pregnancy will go on to develop type 2 diabetes later on in life.7
As CDC understands, the burden of GDM is not limited to its health consequences. Both GDM and type 2 diabetes are tremendously costly illnesses to individual patients and to the US health care system. GDM increased national medical costs by $636 million in 2007,8 but this did not include the future costs of diabetes in these women, which are estimated to be more than $100 billion when taking into account the nationwide cost of diabetes of $245 billion for both sexes.9 These costs translate to a total of $11,078 per pregnancy, or $3,514 more than the average cost.10, 11 Once diagnosed with diabetes, the average yearly healthcare costs for a person with diabetes is $13,700, with $7,900 due to diabetes alone.12 In the U.S. health system, one out of every five federal health care dollars is spent treating people with diabetes.13 We applaud CDC for addressing this important issue, and offer the following recommendations to strengthen the proposed intervention.
II. Improved Screening for GDM and Postpartum Type 2 Diabetes
The Academy recommends that screening for the intervention occur during pregnancy, in order to ensure that eligible participants are not lost to follow-up. We also encourage the inclusion of additional postpartum screenings at three months and at nine months in order to ensure greater participation. These additional times would allow researchers to consider when the participation in and focus on the intervention tapers off for participants, or if participants are better able to focus on the intervention after parenting has become more routine. It would also be important to assess what type, if any, of intervention the women had adhered to during pregnancy, and assess whether the prior intervention effects postpartum habits.
Currently, most women who have prenatal care are tested for GDM during weeks 24-28 of pregnancy. However, 26.3 percent of women do not receive prenatal care and 6 percent receive prenatal care only in the third trimester or never at all.14 Over 237,000 births per year do not include proper testing for GDM.15,16 Testing for GDM is of the utmost importance specifically for preventing the future occurrence of type 2 diabetes.
Current guidelines from the American College of Obstetricians and Gynecologists and the American Diabetes Association recommend postpartum screening women with a history of GDM 6-12 weeks after pregnancy for the persistence of glucose intolerance (or type 2 diabetes) and with lifelong screening at least every 3 years.17 Women previously diagnosed with GDM found to have prediabetes should receive lifestyle interventions or metformin to prevent diabetes, as per the 2016 ADA Standards of Medical Care.18 However, only half of women with a history of GDM are screened.19 Barriers to screening commonly include lack of attendance at postpartum visits, inconsistent screening guidelines, patient cost, poor documentation of GDM on chronic condition lists, poor communication between obstetricians and other health professionals, and time pressure.20 However, interventions such as reminders to physicians or patients can almost triple postpartum screening rates.21 The Academy encourages CDC to collect qualitative data on these barriers to screening, as well as on the effectiveness of interventions to improve screening at more regular intervals and to ensure that the intervention reaches the maximum number of eligible women.
III. Recommendations on the Selection Criteria for Participants
The Academy recommends that CDC increase the proposed number of participants in order to ensure that the study results are scalable and show effectiveness for a broader population, similar to what was done in the NDPP. Due to the disproportionate burden of GDM on non-white populations, we also encourage that CDC include participants with a variety of ethnic backgrounds, including African American, Asian and Hispanic groups.22
IV. Recommendations on Proposed Intervention Designs
The Academy recognizes the importance of testing a cost-effective intervention to reduce the incidence of GDM. In a recent cluster randomized control trial, researchers tested the comparative effectiveness of diabetes prevention strategies by comparing usual care of mailed recommendations versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention.23
The Academy recommends that CDC collect information on the effectiveness of more individualized, evidence-based lifestyle interventions, provided by qualified health professionals, in the proposed intervention. One critical reason to consider including a more individualized intervention is that the populations targeted by the proposed intervention are distinct from the DPP population, which mainly focused on the Medicare population. As has been shown, postpartum women are a distinct population, and may respond more effectively to an individualized intervention that fits into their daily routine, as opposed to a group intervention.
Lifestyle interventions have shown to have a positive impact on the incidence and recurrence of GDM and type 2 diabetes. Weight management has shown to have a positive impact on decreasing recurrence of GDM24 when women lost at least 10 pounds between pregnancies. Another study found decreased odds of GDM in women reporting strenuous and very strenuous physical activity the year prior to pregnancy.25 Diet is also an important consideration in the prevention of GDM. Studies have found increased fat intake in pregnancy, particularly saturated fat to increase the risk of GDM,26,27 but in polyunsaturated fat to reduce the incidence of glucose intolerance in pregnancy.28 Studies have also shown that in postpartum women with a history of GDM, there is a relationship between weight,29 physical activity,30 and diet.31 A prenatal/postpartum study found that women diagnosed with GDM and placed on a modified diet with increased physical activity were 16.1 percent more likely to reach a postpartum weight goal of weight maintenance or weight reduction.32
As described above, Medical Nutrition Therapy (MNT) is an evidence-based lifestyle intervention that has been shown to improve postpartum outcomes for women with GDM. The Academy's Evidence Analysis Library strongly recommends that women with gestational diabetes should receive MNT from a RDN within one week after diagnosis of GDM and should receive a minimum of three nutrition visits.33 Research shows that MNT results in improved maternal and neonatal outcomes for GDM, particularly if the mother is diagnosed early.34 Research indicates that the risk of recurrent GDM, or subsequent type 2 diabetes, is reduced when a RDN provides MNT after delivery.35
A 2015 randomized control trial showed that moderate, individualized lifestyle interventions can reduce the incidence of GDM by 39 percent in high-risk pregnant women.36 The subject in the intervention group received individualized counseling on diet, physical activity and weight control, and also attended a group meeting with a dietitian. A critical component of the intervention was that the counseling was tailored and focused on the individual participant, which is especially important in women who are pregnant and postpartum.37
V. Value of RDNs as Providers
The Academy recommends collecting information on the qualifications of proposed lifestyle coaches. The United States Preventive Services Task Force (USPSTF), in its "Healthy Diet and Physical Activity: Counseling Adults with High Risk for Cardiovascular Disease" recommendation, reviewed the providers who delivered effective interventions. While not defining each provider, USPSTF gave a range of providers who had been demonstrated as effective in performing the Diabetes Prevention Program and the PREMIER intervention, including a dietitian, a nutritionist, a health educator, or a psychologist. Furthermore, at least three of the lifestyle intervention studies used by USPSTF to reach its draft recommendation specifically utilized RDNs to provide the intervention.38 Therefore, the Academy asks that CDC document and evaluate providers most effective at providing the intensive lifestyle interventions, specifically including RDNs in the evaluation.
RDNs remain the most cost-effective, qualified healthcare professional to provide nutrition based lifestyle interventions, including MNT and evidence-based nutrition counseling and weight-loss management services. RDNs have demonstrated competencies and outcomes that differently and less qualified providers of non-medical nutrition services have been yet unable to demonstrate. RDNs are trained to provide motivational interviewing, and have expertise in counseling pregnant women. RDNs are also able to connect patients to community resources, which may be especially helpful for first-time mothers. RDNs' evidence-based national practice guidelines and Evidence Analysis Library are leading, respected tools for effecting positive health outcomes. The Institute of Medicine (IOM) found that "the registered dietitian is currently the single identifiable group of health-care professionals with standardized education, clinical training, continuing education and national credentialing requirements necessary to be directly reimbursed as a provider of nutrition therapy."39
According to a recent study that implicates how important early nutrition interventions are, "[i]ncreased frequency of RD[N] visits is associated with improved BMI outcomes in obese youth participating in a [comprehensive weight management] program regardless of dietary intervention implemented."40 Specifically, "[i]n an analysis that combined the two groups, researchers found a 28 percent increase in odds of success for each additional registered dieti[t]ian visit (P = .05), and success exceeded 78 percent when there was one or more registered dieti[t]ian visit per month compared with 43 percent success with minimal registered dieti[t]ian exposure."41 In evaluating design and effectiveness of the Balance after Baby Intervention, it is critical to ensure that the specially trained practitioners able to deliver the results found in foundational studies demonstrating effective clinical practice are actually the practitioners providing the interventions.
Tackling this complex problem of postpartum gestational diabetes head-on is critical, and early and robust nutrition interventions offer an inexpensive and demonstrably effective solution. We would be happy to serve as a resource as CDC finalizes and begins implementation of BABI2. Please contact either Mary Pat Raimondi at (312) 899-1731, or by email at [email protected], or Stefanie Winston Rinehart at (202) 775-8277, or by email at [email protected], with any questions or requests for additional information.
Mary Pat Raimondi, MS, RDN
Vice President, Strategic Policy and Partnerships
Academy of Nutrition and Dietetics
Stefanie Winston Rinehart, Esq.
Director, HHS Legislation and Policy
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process focused on prevention, delay or management of diseases and conditions, and involves an in-depth assessment, periodic re-assessment and intervention. [Academy of Nutrition and Dietetics' Definition of Terms list, accessed 2 April 2014.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans.
3 DeSisto CL, Kim SY, Sharma AJ. Prevalence Estimates of Gestational Diabetes Mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007–2010. Prev Chronic Dis 2014;11:130415.
4 American Diabetes Association. What is Gestational Diabetes? Accessed January 7, 2015.
5 Centers for Disease Control and Prevention. 2011 National Diabetes Fact Sheet: Gestational Diabetes in the United States. Accessed January 7, 2015.
6 Centers for Disease Control and Prevention. 2014 National Diabetes Statistics Report. Accessed January 5. 2015.
7 Centers for Disease Control and Prevention. 2011 National Diabetes Fact Sheet: Gestational Diabetes in the United States. Accessed January 7, 2015.
8 Chen Y, Quick WW, Yang W, Zhang Y, Baldwin A, Moran J, Moore V, Sahai N, Dall TM. Cost of gestational diabetes mellitus in the United States in 2007. Popul Health Manag. 2009 Jun;12(3):165-74.
9 Centers for Disease Control and Prevention. 2014 National Diabetes Statistics Report. Accessed January 7, 2015.
10 Chen Y, Quick WW, Yang W, Zhang Y, Baldwin A, Moran J, Moore V, Sahai N, Dall TM. Cost of gestational diabetes mellitus in the United States in 2007. Popul Health Manag. 2009 Jun;12(3):165-74.
11 Machlin S. R. and Rohde, F. Health Care Expenses for Uncomplicated Pregnancies. Research Findings No. 27. August 2007. Agency for Healthcare Research and Quality, Rockville, Md.
12 American Diabetes Association (2013). Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care. Col 36 (4): 1033-56.
14 U.S. Department of Health and Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau. Child Health USA 2013. Rockville, Maryland: U.S. Department of Health and Human Services, 2013.
15 U.S. Department of Health and Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau. Child Health USA 2013. Rockville, Maryland: U.S. Department of Health and Human Services, 2013.
16Centers for Disease Control and Prevention. National Vital Statistics Report. Accessed January 7. 2014.
17 American College of Obstetricians and Gynecologists (ACOG). Gestational diabetes mellitus. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2013 Aug. 11 p. (ACOG practice bulletin; no. 137).
18 American Diabetes Association. Management of diabetes in pregnancy. Sec. 12. In Standards of Medical Care in Diabetes-2016. Diabetes Care 2016;39(Supp. 1):S94-S98.
19 Tovar A, Chasan-Taber L, Eggleston E, Oken E. Postpartum screening for diabetes among women with a history of gestational diabetes mellitus. Prev Chronic Dis. 2011 Nov;8(6):A124. Epub 2011 Oct 17. Review.
20 Baker AM, Brody SC, Salisbury K, Schectman R, Hartmann KE. Postpartum glucose tolerance screening in women with gestational diabetes in the state of North Carolina. N C Med J. 2009 Jan-Feb;70(1):14-9.
21 Clark HD, Graham ID, Karovitch A, Keely EJ. Do postal reminders increase postpartum screening of diabetes mellitus in women with gestational diabetes mellitus? A randomized controlled trial. Am J Obstet Gynecol. 2009;200(6):634–6e1.
22 Centers for Disease Control and Prevention. 2014 National Diabetes Statistics Report. Accessed January 5. 2016.
23 Ferrara, A., et al. Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women with Gestational Diabetes Mellitus: The Finnish Gestational Diabetes Prevention Study(RADIEL). Diabetes Care. January 2016. 39:1;65-74.
24 NL, Hendrickson AF, Schellenbaum GD, Mueller BA. Weight Change and the Risk of Gestational Diabetes in Obese Women. Epidemiology 2004;15(6):733-737.
25 Rudra CB, Williams MA, Lee IM, Miller RS, Sorensen TK. Perceived Exertion in Physical Activity and Risk of Gestational Diabetes Mellitus. Epidemiology 2006; 17(1): 31-37.
26 Saldana TM, Siega-Riz AM, Adair LS. Effect of macronutrient intake on the development of glucose intolerance during pregnancy. Am J Clin Nutr 2004; 79:479-86.
27 Bo S, Menato G, Lezo A, Signorile A, Bardelli C, De Michieli F, Massobrio M, Pagano G. Dietary fat and gestational hyperglycaemia. Diabetologia 2001;44:972-978.
28 Chu, S., et al. Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care 30:2070–2076, 2007.
29 Lauenborg J, et al. Increasing incidence of diabetes after gestational diabetes: a long-term follow-up in a Danish population. Diabetes Care 2004;27(5):1194-9.
30Smith BJ, Cheung NW, Bauman AE, Zehle K, McLean M. Postpartum physical activity and related psychosocial factors among women with recent gestational diabetes mellitus. Diabetes Care 2005 Nov;28(11):2650-4.
31 Stage E, Ronneby H, Damm P. Lifestyle change after gestational diabetes. Diabetes Res Clin Pract 2004;63(1):67-72.
32 Ferrara, A., et al. Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women with Gestational Diabetes Mellitus: The Finnish Gestational Diabetes Prevention Study(RADIEL). Diabetes Care. January 2016. 39:1;65-74.
33 Academy of Nutrition and Dietetics Evidence Analysis Library. "GDM Executive Summary of Recommendations" Access February 1, 2016.
34 Academy of Nutrition and Dietetics Evidence Analysis Library. "GDM: Monitor and Evaluate MNT Effectiveness." Access February 1, 2016.
35 Academy of Nutrition and Dietetics Evidence Analysis Library. "GDM:Prevention of GDM Recurrence/Type 2 Diabetes." Access February 1, 2016.
36 Ferrara, A., et al. Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women with Gestational Diabetes Mellitus: The Finnish Gestational Diabetes Prevention Study(RADIEL). Diabetes Care. January 2016. 39:1;65-74.
38 Armato J, DeFronzo RA, Abdul-Ghani M, et al. Successful treatment of prediabetes in clinical practice: targeting insulin resistance and cell dysfunction. Endocr Pract. 2012; 18(3): 342-50; Katula JA, Vitolins MZ, Morgan TM, et al. The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial. Am J Prev Med. 2013; 44(4 Suppl 4); S324-32; Penn L, White M, Oldroyd J, et al. Prevention of type 2 diabetes in adults with impaired glucose tolerance: the European Diabetes Prevention RCT in Newcastle upon Tyne, UK. BMC Public Health. 2009; 9:342.
39 Committee on Nutrition Services for Medicare Beneficiaries."The Role of Nutrition in Maintaining Health in the Nation's Elderly: Evaluating Coverage of Nutrition Services for the Medicare Population."Washington, DC: Food and Nutrition Board, Institute of Medicine; January 1, 2000 (published).
40 Kirk Shelley, Woo Jessica G., Jones Margaret N., and Siegel Robert M. Childhood Obesity. April 2015, 11(2): 202-208. doi:10.1089/chi.2014.0079.