Examples of Successful Proposals
Short Survey of Prepregnancy and Early Pregnancy Nutritional Practices of Women in Central Pennsylvania
Identifying Information
The lead investigators for this proposal are Terry Hartman, PhD, MPH, RD, Assistant Professor, Nutrition, The Pennsylvania State University and J. Chris Carey, MD, Professor and Vice Chair, Obstetrics and Gynecology, College of Medicine, Hershey Medical Center.
Collaborating investigators from outside Penn State University include Marlene Goldman, ScD, Associate Professor, Division of Epidemiology, Harvard School of Public Health, and Director of Women's Health Research, The New England Research Institute and the physicians affiliated with the Central Pennsylvania Investigational Group (CPIG). Dr. Carey, as Chair, represents CPIG, and has presented this concept proposal to them. The CPIG includes Hershey Medical Center, Penn State Geisinger Health System North Central Region, Lehigh Valley Hospital and Health System, York Health System, and Reading Hospital and Medical Center.
Abstract
Preconceptional and very early pregnancy nutritional status may be important predictors of pregnancy outcome. There is little data available about the nutritional information available to women planning a pregnancy or about their dietary practices when they are trying to conceive or very early in pregnancy. We propose to design and administer a short survey to determine what women in Central Pennsylvania are doing to prepare themselves nutritionally before pregnancy and in the early weeks of their pregnancies. Information will also be collected pertaining to nutrition and other health-related information received by women at their first prenatal care visits. Basic demographic information, parity, and whether the pregnancy was planned or unplanned will be determined. A secondary objective is to follow this group of women through their pregnancies, to collect data on pregnancy outcome, and to explore potential associations between dietary practices and pregnancy outcome.
Specific Aims and Objectives
- Determine what percentage of women in Central Pennsylvania schedule a visit with their physicians before they attempt to become pregnant. Additionally, for women who schedule these visits, document what types of health-related information their health care providers share with them (e.g. nutrition, alcohol use, smoking, physical activity)
- Determine whether nutritional changes are made by women planning to become pregnant.
- Ascertain what health-related information is shared with newly pregnant women at their first prenatal visit (e.g. weight gain, supplement use, alcohol, smoking, physical activity).
- Compare whether the information received on nutrition and health during pregnancy differs by selected demographic factors including age, educational attainment, and parity.
- Collect data on pregnancy outcome for participants via medical record data abstraction. Explore potential associations between dietary practices and selected pregnancy outcome variables (e.g. miscarriage, preterm delivery, birthweight).
Background and Rationale
Nutritional intake during pregnancy is regarded as an important contributor to pregnancy outcome. Appropriate weight gain and adequate intake of nutrients, such as iron and folic acid, have long been recognized as important to pregnancy outcome. As a result, recommendations have been made for weight gain and intake of essential nutrients during pregnancy by the National Academy of Sciences (National Academy of Sciences, 1990) and women are encouraged by their health care providers to use prenatal vitamin/mineral supplements during pregnancy.
Women often do not see their health care providers until 2-3 months into their pregnancies. Pennsylvania women under age 25 tend to seek care later than older women, and women from rural areas may also delay prenatal care. The infant death rate in Pennsylvania is slightly worse than the national average (7.7 v. 7.3 per 1,000 live births). Similarly, 7.6% of Pennsylvania infants are of low birth weight, compared to 7.5% of all US infants (Pennsylvania Department of Health data).
The first few months of pregnancy may be critical to the growth and development of the fetus and placenta. Inadequate nutritional intake during this time period may predispose vulnerable women to complications later in pregnancy and may adversely affect the growing fetus. Women in poor nutritional status prior to pregnancy may be at increased risk for complications or poor pregnancy outcomes (Cnattingius, 1998; National Academy of Sciences, 1990).
There is little data available about the nutritional information available to women planning pregnancy or about their dietary practices when they are trying to conceive or very early in pregnancy. In addition, there is little data available on the preconceptional and early pregnancy dietary intake of specific nutrients (e.g. folic acid, zinc, iron) known to be associated with pregnancy outcome. In the 1998 Behavioral Health Risks Survey of Pennsylvania Adults, only 28% of adults aged 18-44 believed that taking folic acid would help pregnant women to prevent birth defects (Pennsylvania Department of Health data).
Data collected late in pregnancy or after delivery may be subject to recall bias. Prospectively collected data on diet quality and intake of key nutrients both prior to and during early pregnancy may provide valuable insight into potential risk factors for adverse outcomes for both mother and child.
Methods
Participants will be women seen for their first prenatal visit by physicians/midwives affiliated with participating CPIG medical centers. Approximately 1,000 women will be surveyed. A total of 7,000 infants are delivered per year at participating centers; thus, by collecting data for 2-3 months this goal should be reached.
A questionnaire will be developed and approved by the lead physicians for participating centers. This questionnaire will ask participants about nutrition and health-related practices prior to and early in pregnancy. A draft is included as Appendix A.
Primary Objectives
Women will be asked to complete the surveys by nurses at the site where they receive their prenatal care. If they agree, they will be asked by the nurse to sign a consent form, will be given the questionnaire, and asked to complete it within one week. An addressed, stamped envelope will be provided. This will allow the participant to complete the form at a convenient time and mail it herself. It should also minimize the likelihood that participants will respond in a fashion that they believe their health care provider would view favorably (when this may not be an accurate response). Participants who agree to complete the questionnaire will be given a small incentive gift. This incentive should encourage the participants to follow through by completing and mailing the form.
The completed questionnaires will be mailed to the study center in the Nutrition Department at Penn State, University Park. There they will be edited, the data entered, and analyzed. Results will be generated for the group as a whole and separately for each participating center. A short written report will be prepared and shared with participating centers. If appropriate, a manuscript will be written and submitted to a journal for peer review.
Secondary Objectives
At the prenatal visit where they receive a questionnaire, women will also be asked if they will allow information related to their pregnancy outcome to be abstracted from their medical records at a later date.
Trained individuals will abstract pregnancy outcome data from the medical records of consenting participants. The data will be edited and entered. Potential relationships between dietary factors and selected pregnancy outcomes will be evaluated. If appropriate, a manuscript will be written and submitted to a journal for peer review.
Timeline
| May, 2000 | Finalize questionnaire, submit materials to appropriate Institutional Review Boards |
| May, 2000 | Meet with nurses and support staff |
| June-August, 2000 | Data collection, editing, entry |
| August-September, 2000 | Analysis, reporting |
| January-April, 2001 | Data collection, editing, entry |
| May-June, 2001 | Analysis, reporting |
Relevance to the CYFC
This proposal is consistent with the goals of the CYFC in several areas.
This an interdisciplinary project including Penn State Faculty and leaders at participating medical centers throughout Pennsylvania. This project builds on another CYFC-funded proposal by Dr. Carey to form the Central Pennsylvania Investigational Group.
This proposal focuses on nutrition during pregnancy, a critical time for both mother and infant. The investigators believe that nutritional intake immediately prior to and early in pregnancy may be associated with both the health of the mother during the pregnancy and with many aspects of early fetal development. Prospectively collected information on the nutritional practices in a large group of pregnant women will guide the development of other projects targeting this population.
As a result of this proposed research, ties will be forged between the Penn State Nutrition Department and the Hershey Medical Center Obstetrics and Gynecology Department. A collaborative relationship will be developed between those two groups, the other participating medical centers, and Dr. Goldman's group at the New England Research Institute.
Anticipated Outcomes
The primary outcome of this project will be the collection and evaluation of dietary and related health practices among women planning pregnancy in Pennsylvania.
This data will be used as supporting data in a proposal for a large prospective study to evaluate the effects of diet and lifestyle practices on fertility and early pregnancy loss. To justify such a large and costly epidemiologic study, baseline data on current practices among this population is essential. Any suggested associations between diet and pregnancy outcomes observed in this dataset would further support this proposal. Drs. Hartman and Goldman are planning to prepare a proposal and seek funding from NICHD in the upcoming year.
The data from this project may be used by the participating centers to make modifications to better meet the needs of the clients they serve.
This data may be used in the future to plan and seek outside funding for a nutrition intervention targeting pregnant women. Dr. Hartman has previously been involved in nutrition interventions conducted at the workplace and in community and clinical settings and continues to have an interest in nutrition intervention.
The investigators involved with this project share a common interest in positively impacting the health of women of childbearing ages and their families. A potential outcome of this collaboration is the generation of new ideas for other projects targeting this population.
Personnel
Terry Hartman is an Assistant Professor of Nutrition at The Pennsylvania State University. Dr. Hartman is a nutrition epidemiologist and has worked previously on a large cohort study of pregnant women at the University of Minnesota. Dr. Hartman also worked for nearly three years as a Regional Nutritionist for the Supplemental Food Program for Women, Infants, and Children (WIC). Dr. Hartman's research interest is in diet and reproductive health outcomes including dietary effects on hormones, pregnancy outcomes, and reproductive cancers, primarily breast and prostate.
J. Chris Carey is Professor and Vice Chair of Obstetrics and Gynecology and Chief of Women's Health, Hershey Medical Center. Dr. Carey has extensive experience in multi-center trials in pregnancy. Dr. Carey has been an investigator in the Vaginal Infections and Preterm Birth Study and the Maternal Fetal Medicine Units Network, both large multicenter studies funded by the NICHD. Dr. Carey is currently the Chair of the CPIG.
Marlene Goldman is Associate Professor, Division of Epidemiology, Harvard School of Public Health and Director of Women's Health Research, New England Research Institute. Dr. Goldman is a reproductive epidemiologist with experience in the design, conduct, and analysis of multi-site epidemiologic studies focusing on women's reproductive health.
Elyse Laufer, Nutrition Graduate Student, will serve as Study Coordinator for the project. Ms. Laufer is currently employed during the academic year by the Department of Nutrition, Penn State, and is completing a Master's Degree under the direction of Dr. Hartman.
Budget
| Personnel | ||
| Coordinator summer salary (160 hours @ 10.83) | 1,732.80 | |
| Data entry (363 hours @ 7.00) | 2,541.00 | |
| Data abstraction (160 hours @ 7.00) | 1,120.00 | |
| Supplies | ||
| Paper, copying, envelopes | 750.00 | |
| Postage (1,000 @ 0.55) + miscellaneous ($200) | 750.00 | |
| Telephone Service | ||
| (estimated at $200 for long-distance calling and faxing) | contributed by Nutrition Dept. PSU |
|
| Travel | ||
| To/from Hershey, other 4 centers for PI and coordinator to setup, provide training, and coordinate data abstraction (200 miles * 10 * 0.31) | 620.00 | |
| Training | ||
| (For nurses/support staff who distribute questionnaires to patients) Refreshments (5 centers @ $75) | 375.00 | |
| Incentives | ||
| Small gift to be given to women for participating (1000 * $2) | 2,000.00 | |
| Total | 9,888.80 | |
Budget Justification:
Personnel
A graduate student project coordinator under the direction of Dr. Hartman will coordinate activities related to this project including organizing meetings with staff at participating centers as needed, finalizing the development and distribution of the questionnaires, supervising the data entry person, and completing simple descriptive analyses. Support is requested for this graduate student over the summer months when departmental support is not available for her salary.
Data entry is required for approximately 1000 questionnaires and data abstraction forms plus a 10% quality control sample. Approximately 20 minutes is needed per participant for data entry and an additional 10 minutes for data abstraction.
Supplies
Supplies requested are for printing, postage for questionnaires and other study-related materials sent to the participating centers.
Travel
The PI and coordinator plan to travel to each of the participating centers to conduct a short training for nurses and support staff.
Training
A very short training will be held at each of the centers for the nurses and supporting staff who will be asked to distribute the questionnaires. The purpose of this training is two-fold (1) to garner support and obtain feedback from staff and (2) to provide instruction on the distribution and collection of the questionnaires. We wish to provide some light refreshments for these meetings.
Incentives
To encourage participation a small incentive will be given to women as they are asked to complete the questionnaire. We will develop something based on input from staff at participating centers; however, we hope to develop something like a key chain printed with the study name and participating centers or possibly a refrigerator magnet with a simple educational message.
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