August 23, 2016
Acting Administrator James Macrae, MA, MPP
Health Resources and Services Administration
U.S. Department of Health and Human Services
Rockville, MD 20857
Re: Healthy Start Evaluation and Quality Improvement OMB No. 0915-0338 — Revision
Dear Mr. Macrae:
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Health Resources and Services Administration (HRSA) in response to the information collection "Healthy Start Evaluation and Quality Improvement OMB No. 0915-0338—Revision" published in the June 24, 2016 Federal Register. The Academy is the world's largest organization of food and nutrition professionals, with more than 100,000 members comprised of registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists. We are committed to improving the nation's health through food and nutrition and providing medical nutrition therapy (MNT)2 and other nutrition counseling services to meet the health needs of all citizens, including pregnant women and their children.
The Academy strongly supports this information collection as necessary and beneficial. It is extremely important for Healthy Start Programs to collect information regarding program interventions and how these impact health outcomes for a diversity of participant groups. Analysis of relationships between program activities and participant outcomes will enable effective, efficient program planning that meets participant needs and will highlight cost/benefit ratio of program administration vs. participant benefit. We note that this level of detail on maternal and infant health has not been collected recently and is crucial for increasing our understanding of methods to reduce adverse health outcomes in this population.
A. Accuracy of the Estimated Burden
The Academy notes that survey administrators are generally realistic about the estimated burden. However, it seems that participant interviews for this information collection will be given at various time points throughout the perinatal period, and some of the interviews seem like they will be more lengthy than anticipated. We encourage HRSA to detail the methodology to clarify whether these interviews will be given at the sub-set of PRAMS sites (i.e., the document reads "PRAMS sites shall receive funds in the amount of $100 per birth/HS respondent to cover staff time for the additional interviews, survey printing, incentives, supplies, mailings, and the data entry required by the oversampling.") We question whether this time estimated is sufficient for these interviews if they are those described in the pregnancy, prenatal, etc. questionnaires. Members suggest this additional time would be a substantial burden for sites and participants requiring larger, and perhaps increasing, incentives. Collecting longitudinal data can be particularly challenging with low-income individuals who tend to be more transient and who may switch phone numbers more frequently, despite program enrollment. In order to achieve adequate attrition, participants need to be properly reimbursed for their time and effort throughout this period of interviews.
B. Enhancing the Quality, Utility, and Clarity of Information
Although the below recommendations focus specifically on the Preconception and Interconception screenings, this feedback could be applied to all six forms with slight semantic alterations. Since preconception and interconception health directly impacts the intrauterine environment of the mother during implantation and early fetoplacental growth and development, data collection would be even more comprehensive if it encompassed the mother's preconception/interconception level of physical activity (PA) and/or inactivity. Activity and inactivity affects maternal cardiometabolic and immunological health as well as overall mental and physical well-being. Research included in the attached Addendum consistently shows that women's activity levels either stay the same or more likely go down during pregnancy, so having a healthy PA habit prior to conception(s) bodes well for the mother, baby, and family across the lifecycle. The Academy questions whether HRSA could identify whether prospective mothers (and their partners/elders) may have misinformation that discourages or frightens them from keeping active once pregnant.
In addition, the Academy encourages HRSA to address activity level in a way that does not focus solely on formal exercise. Some of the most at-risk individuals rarely participate in formal exercise, but might regularly participate in short, valuable spurts of activity that seldom appear on a PA questionnaire. The questionnaire could ask how often the following occur within the past 3 months (with format of "more than 1x/d," "daily or almost daily," "weekly," or "never"):
- I take 1 or more flight of stairs
- I dance around at home or go out dancing
- I walk around regularly at home or work
- I stand in one spot for a prolonged period of time (>3 hours without a break)
- I sit for a prolonged period of time (>3 hours without a break)
- I participate in an organized sport, do my own fitness workouts, or do work/hobby that involves some strenuous physical labor.
The Academy also queries whether iron deficiency anemia was purposely excluded, as we believe its inclusion would prove valuable. Lastly, we encourage HRSA to add a second question about alcohol (2 or 3 drinks per day) that could better elicit data related to binge drinking, particularly given the increase in portion sizes of alcoholic beverages in recent decades.
The Academy appreciates the opportunity to offer comments to HRSA regarding Healthy Start Evaluation and Quality Improvement . Please contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at email@example.com or Pepin Tuma at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
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, http://www.eatright.org/scope/, accessed 31 June 2012.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans.
Appendix: Relevant Research
Physical Activity (PA):
Before and between pregnancy as optimal time to establish this lifestyle habit
Sorensen TK, Williams MA, Lee IM, Dashow EE, Thompson ML, Luthy DA. Recreational physical activity during pregnancy and risk of preeclampsia. Hypertension. 2003 Jun;41(6):1273-80.
The potential benefits and risks of physical activity before and during pregnancy are not well studied. We studied the relation between recreational physical activity and the risk of preeclampsia in a case-control study of 201 preeclamptic and 383 normotensive pregnant women. Participants provided information about the type, intensity, frequency, and duration of physical activity performed during the first 20 weeks of pregnancy and during the year before pregnancy. Women who engaged in any regular physical activity during early pregnancy, compared with inactive women, experienced a 35% reduced risk of preeclampsia (odds ratio, 0.65; 95% confidence interval [CI], 0.43 to 0.99). Compared with inactive women, those engaged in light or moderate activities (ie, activities with metabolic-equivalent scores <6) experienced a 24% reduced risk of preeclampsia (95% CI, 0.48 to 1.20). The corresponding reduction for women participating in vigorous activities (metabolic equivalent scores > or =6) was 54% (95% CI, 0.27 to 0.79). Brisk walking (average walking pace > or =3 mi/h), when compared with no walking at all, was associated with a 30% to 33% reduction in preeclampsia risk. Stair climbing was inversely associated with the risk of preeclampsia (P for trend=0.039). Recreational physical activity performed during the year before pregnancy was associated with similar reductions in preeclampsia risk. These data suggest that regular physical activity, particularly when performed during the year before pregnancy and during early pregnancy, is associated with a reduced risk of preeclampsia.
Egeland GM, et al. Preconception cardiovascular risk factor differences between gestational hypertension and preeclampsia: cohort Norway study. Hypertension. 2016; 67: 1173-1180
Preconception predictors of gestational hypertension and preeclampsia may identify opportunities for early detection and improve our understanding of the pathogenesis and life course epidemiology of these conditions. Female participants in community-based Cohort Norway health surveys, 1994 to 2003, were prospectively followed through 2012 via record linkages to Medical Birth Registry of Norway. Analyses included 13 217 singleton pregnancies (average of 1.59 births to 8321 women) without preexisting hypertension. Outcomes were gestational hypertension without proteinuria (n=237) and preeclampsia (n=429). Mean age (SD) at baseline was 27.9 years (4.5), and median follow-up was 4.8 years (interquartile range 2.6–7.8). Gestational hypertension and preeclampsia shared several baseline risk factors: family history of diabetes mellitus, pregravid diabetes mellitus, a high total cholesterol/high-density lipoprotein cholesterol ratio (>5), overweight and obesity, and elevated blood pressure status. For preeclampsia, a family history of myocardial infarction before 60 years of age and elevated triglyceride levels (≥1.7 mmol/L) also predicted risk while physical activity was protective. Preterm preeclampsia was predicted by past-year binge drinking (≥5 drinks on one occasion) with an adjusted odds ratio of 3.7 (95% confidence interval 1.3–10.8) and by past-year physical activity of ≥3 hours per week with an adjusted odds ratio of 0.5 (95% confidence interval 0.3–0.8). The results suggest similarities and important differences between gestational hypertension, preeclampsia, and preterm preeclampsia. Modifiable risk factors could be targeted for improving pregnancy outcomes and the short- and long-term sequelae for mothers and offspring.
Genest DS, Falcao S, Gutkowska J, Lavoie JL. Impact of exercise training on preeclampsia: potential preventive mechanisms. Hypertension. 2012 Nov;60(5):1104-9.
Preeclampsia is characterized by hypertension and de novo proteinuria after 20 weeks of pregnancy. It is the leading cause of perinatal morbidity and mortality in the developed world, and to date, the only means of treating the disease is by inducing delivery. Many studies have shown the benefits of exercise training on normal pregnancy. Conversely, because the impact of exercise on reducing the risk of preeclampsia has long been debated, the American College of Obstetricians and Gynecologists has yet to support the prescription of exercise training to women at risk of developing the disease. There is, however, a significant body of evidence in support of the protective role of exercise training against preeclampsia. A recent animal study demonstrated that many preeclampsia features can be eliminated with prenatal followed by gestational exercise training. Hence, the present article reviews the literature on the impact of exercise training on preeclampsia risk, as well as the mechanisms that may be involved.
Mudd LM, et al. Michigan Alliance for National Children's Study. Factors associated with women's perceptions of physical activity safety during pregnancy. Prev Med. 2009 Aug-Sep;49(2-3):194-9.
Health benefits of physical activity (PA) during pregnancy have been noted, but women's perceptions of PA safety have been little studied.
To examine associations among PA participation, safety perceptions, and demographic characteristics.
Pregnant women were recruited from nine clinics in Grand Rapids, MI (USA) from April to October, 2006. Demographics, participation in moderate and vigorous PA, and perceived safety of both intensities (5-pt Likert scales) were reported. Logistic regression analyses were used to estimate associations.
Of 342 eligible women, 296 provided complete PA information. Most (88%) participated in some PA and felt moderate PA was safe (89%), but only 36% felt vigorous PA was safe. Feeling unsafe/unsure about moderate PA was associated with non-White race/ethnicity, low education, low income, not participating in moderate PA, and/or not intending to be active during pregnancy. Hispanic ethnicity, low education, nulliparity, and not participating in moderate or vigorous PA were associated with feeling unsafe/unsure about vigorous PA.
Pregnant women generally feel that moderate PA is safe, but are less certain about vigorous PA. More work is needed to inform pregnant women about the benefits of moderate PA, especially among non-White and low education/income populations.
Particularly interesting seminal research (involving physical activity lifestyle intervention) that included disproportionate number of women with polycystic ovary syndrome (PCOS). PCOS affects 5-10% of women of childbearing age and potentially has negative effects on fertility as well as maternal and fetal outcomes:
- Clark, AM, et al. Weight loss in obese infertile women results in improvement in reproductive outcome for all forms of fertility treatment. Human Reproduction 13 (6): 1502-1505, 1998.
- Clark, AM et al conducted a pilot study published in Human Reproduction 10 (10): 2705-2712, 1995.
Iron Deficiency Anemia prior to conception:
Ronnenberg AG, Wood RJ, Wang X, Xing H, Chen C, Chen D, Guang W, Huang A, Wang L, Xu X. Preconception hemoglobin and ferritin concentrations are associated with pregnancy outcome in a prospective cohort of Chinese women. J Nutr. 2004 Oct;134(10):2586-91.
Prenatal anemia and iron deficiency are associated with adverse birth outcomes, but no previous studies have examined the relation between preconception anemia, iron deficiency, and pregnancy outcome in healthy women. We measured hemoglobin (Hb), ferritin, transferrin receptor (TfR), and vitamins B-6, B-12, and folate concentrations before pregnancy in 405 Chinese women (median time from sample collection to gestation end = 316 d). Both mild (95 /=60 microg/L) ferritin were also significantly associated with lower birthweight (106 and 123 g, respectively). The risks of low birthweight (LBW) and fetal growth restriction (FGR) were significantly greater among women with moderate anemia compared with nonanemic controls [odds ratio (OR): 6.5; 95% CI: 1.6, 26.7; P = 0.009 and OR: 4.6; 95% CI: 1.5, 13.5; P = 0.006, respectively]. TfR and low ferritin were not associated with adverse birth outcome, but elevated ferritin, which could be a marker of inflammation, was associated with increased risk of LBW (OR: 2.2; 95% CI: 0.9, 5.7; P = 0.09) and FGR (OR: 2.7; 95% CI: 1.3, 5.6; P = 0.008). Preconception anemia, particularly iron-deficiency anemia, was associated with reduced infant growth and increased risk of adverse pregnancy outcome in Chinese women.
Jack BW, et al. The clinical content of preconception care: an overview and preparation of this supplement. Am J Obstet Gynecol December 2008 Volume 199, Issue 6, Supplement B: S266–S279.
In June 2005, the Select Panel on Preconception Care established implementation workgroups in 5 areas (clinical, public health, consumer, policy and finance, and research and surveillance) to develop strategies for the implementation of the Centers for Disease Control and Prevention recommendations on preconception health and healthcare. In June 2006, members of the clinical workgroup asked the following questions: what are the clinical components of preconception care? What is the evidence for inclusion of each component in clinical activities? What health promotion package should be delivered as part of preconception care? Over the next 2 years, the 29 members of the clinical workgroup and > 30 expert consultants reviewed in depth > 80 topics that make up the content of the articles that are contained in this supplement. Topics were selected on the basis of the effect of preconception care on the health of the mother and/or infant, prevalence, and detectability. For each topic, the workgroup assigned a score for the strength of the evidence that supported its inclusion in preconception care and assigned a strength of the recommendation. This article summarizes the methods that were used to select and review each topic and provides a summary table of the recommendations.