Food Program for Pregnancy Complications
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Christiana Care Health Services
Disqualifiers: Diabetes, Multiple pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The purpose of this study is to conduct a pilot randomized controlled trial of a food is medicine community health worker intervention called the Women's Health Delaware Food Farmacy compared to the usual standard of care among pregnant ChristianaCare patients at risk for adverse clinical outcomes. The pilot study has three specific aims: Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed Aim 2: To determine the prevalence of and change in social needs Aim 3: To evaluate the effectiveness of the Women's Health Delaware Food Farmacy on maternal and child health, healthcare utilization, and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Usual Standard of Care, Women's Health Delaware Food Farmacy for pregnancy complications?
Research shows that a healthy diet during pregnancy, which includes a variety of nutrient-rich foods like fruits, vegetables, and whole grains, can lead to fewer pregnancy complications and better birth outcomes. Programs that provide nutritional support and education, similar to the Women's Health Delaware Food Farmacy, have been associated with higher birth weights and reduced rates of low birth weight infants.12345
Is the Food Program for Pregnancy Complications safe for humans?
The research highlights the importance of a balanced diet during pregnancy, emphasizing nutrient-dense foods like fruits, vegetables, and whole grains, which are generally safe and beneficial. However, specific safety data for the Food Program for Pregnancy Complications under its various names is not directly addressed in the provided studies.16789
How does the Women's Health Delaware Food Farmacy treatment differ from other treatments for pregnancy complications?
The Women's Health Delaware Food Farmacy treatment is unique because it focuses on providing nutrient-dense, whole foods to improve pregnancy outcomes, unlike standard treatments that may not emphasize dietary changes. This approach is similar to the WIC program, which has shown benefits like increased intake of essential nutrients and improved birth outcomes.1261011
Eligibility Criteria
This trial is for pregnant women receiving care at ChristianaCare who are at risk of complications like high blood pressure, gestational diabetes, eclampsia, pre-eclampsia, or obesity. Specific eligibility details aren't provided but typically include factors like age and health status.Inclusion Criteria
ChristianaCare Women's Health patient
I am 18 years old or older.
I am between 1 and 3 months pregnant.
See 4 more
Exclusion Criteria
Diagnosed with severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization
I have been diagnosed with diabetes.
Multiple pregnancy
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive medically tailored groceries and interact weekly with a Community Health Worker from enrollment to 4 weeks after delivery
Varies (from enrollment to 4 weeks postpartum)
Weekly interactions (in-person or virtual)
Follow-up
Participants are monitored for maternal and child health outcomes, healthcare utilization, and clinical event outcomes
Up to 90 days postpartum
Postpartum assessments
Treatment Details
Interventions
- Usual Standard of Care (Other)
- Women's Health Delaware Food Farmacy (Behavioural Intervention)
Trial OverviewThe study is testing a 'Food is Medicine' program by Women's Health Delaware Food Farmacy against the standard healthcare pregnant women usually receive. It aims to see if this program can improve maternal and child health outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Women's Health Delaware Food FarmacyExperimental Treatment1 Intervention
Participants will receive medically tailored groceries (10 meals per person in the household per week from enrollment to 4 weeks after delivery) high in micronutrients that are delivered to their homes weekly. They will also interact weekly with their assigned Community Health Worker to address social needs and patient-centered goals.
Group II: Usual Standard of CareActive Control1 Intervention
Participants will receive the usual standard of care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ChristianaCare Christiana HospitalNewark, DE
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Who Is Running the Clinical Trial?
Christiana Care Health ServicesLead Sponsor
University of DelawareCollaborator
References
The importance of nutrition in pregnancy and lactation: lifelong consequences. [2023]Most women in the United States do not meet the recommendations for healthful nutrition and weight before and during pregnancy. Women and providers often ask what a healthy diet for a pregnant woman should look like. The message should be "eat better, not more." This can be achieved by basing diet on a variety of nutrient-dense, whole foods, including fruits, vegetables, legumes, whole grains, healthy fats with omega-3 fatty acids that include nuts and seeds, and fish, in place of poorer quality highly processed foods. Such a diet embodies nutritional density and is less likely to be accompanied by excessive energy intake than the standard American diet consisting of increased intakes of processed foods, fatty red meat, and sweetened foods and beverages. Women who report "prudent" or "health-conscious" eating patterns before and/or during pregnancy may have fewer pregnancy complications and adverse child health outcomes. Comprehensive nutritional supplementation (multiple micronutrients plus balanced protein energy) among women with inadequate nutrition has been associated with improved birth outcomes, including decreased rates of low birthweight. A diet that severely restricts any macronutrient class should be avoided, specifically the ketogenic diet that lacks carbohydrates, the Paleo diet because of dairy restriction, and any diet characterized by excess saturated fats. User-friendly tools to facilitate a quick evaluation of dietary patterns with clear guidance on how to address dietary inadequacies and embedded support from trained healthcare providers are urgently needed. Recent evidence has shown that although excessive gestational weight gain predicts adverse perinatal outcomes among women with normal weight, the degree of prepregnancy obesity predicts adverse perinatal outcomes to a greater degree than gestational weight gain among women with obesity. Furthermore, low body mass index and insufficient gestational weight gain are associated with poor perinatal outcomes. Observational data have shown that first-trimester gain is the strongest predictor of adverse outcomes. Interventions beginning in early pregnancy or preconception are needed to prevent downstream complications for mothers and their children. For neonates, human milk provides personalized nutrition and is associated with short- and long-term health benefits for infants and mothers. Eating a healthy diet is a way for lactating mothers to support optimal health for themselves and their infants.
The impact of the Women, Infants and Children Food Supplement Program on birth outcome. [2022]Our purpose was to compare the birth outcomes of pregnant women in the Women, Infants and Children Food Supplement Program with women not in the program.
Behavioral, health, and cost outcomes of an HMO-based prenatal health education program. [2019]This report presents the results of an evaluation of a prenatal health education program conducted within a health maintenance organization (HMO) setting. Specifically, the behavioral, birth, and treatment-cost outcomes for 57 women in an experimental group who received individual nutrition counseling and a home-correspondence smoking cessation program were evaluated against the outcomes for 72 women in a control group who received standard prenatal care. In comparison with the controls, a greater percentage of women in the experimental group quit smoking during pregnancy (49.1 percent versus 37.5 percent). Of those who smoked throughout their pregnancy, women in the experimental group had a greater reduction in their mean rate of daily smoking. A significantly greater percentage of experimental group women adjusted their diets during the prenatal period (91 percent versus 68 percent), and particular success was achieved in increased consumption of dairy products and vegetables, decreased consumption of coffee, and adequate weight gain during pregnancy. Analysis of birth outcome data revealed that infants born to the experimental group had a significantly higher mean birth weight than infants born to the controls (121.34 oz versus 113.64 oz). The experimental group also had fewer low birth weight infants (7.0 percent versus 9.7 percent for controls). Hospital treatment cost savings associated with the reduced incidence of low birth weight infants among experimental group women yielded an overall benefit-cost ratio for the prenatal program of approximately 2:1.
Multiple factors as mediators of the reduced incidence of low birth weight in an urban clinic population. [2022]A five year prospective observational study was initiated in 1985 at Howard University to describe the nutritional, clinical, dietary, lifestyle, environmental, and socioeconomic characteristics of women who enrolled in the hospital prenatal clinic. The participants were nulliparous, between the ages of 18 and 35 years, free of diabetes and abnormal hemoglobins (sickle cell disease, thalassemia, and hemoglobin C), and had been admitted prior to the 29th week of gestation. During the three year period from 1985-1988, the incidence of low birth weight (LBW) in 239 deliveries to project participants was 8.3%, whereas that of women simultaneously enrolled in the prenatal clinic with the same eligibility requirements, but not recruited for the research project, was 21.9% (P = 0.001). The incidence of LBW in infants of African American women with these eligibility requirements who were delivered by private physicians but were not enrolled in the project, was 6.3%. The reduction in LBW of infants delivered to participants in this study is attributed to the enhanced social and psychological support by project staff during their pregnancies. The caring, sensitive demeanor of the research project staff may have empowered the participants to (a) give greater compliance (91 vs. 70%) in the ingestion of the routine physician-prescribed vitamin/mineral supplement, which provided nutrients low (less than 70% of the 1989 RDAs) in their customary diets, such as folate, pyridoxine, iron, zinc, and magnesium and (b) show greater accountability in keeping prenatal clinic appointments.(ABSTRACT TRUNCATED AT 250 WORDS)
Practice paper of the Academy of Nutrition and Dietetics abstract: nutrition and lifestyle for a healthy pregnancy outcome. [2019]It is the position of the Academy of Nutrition and Dietetics that women of childbearing age should adopt a lifestyle optimizing health and reducing risk of birth defects, suboptimal fetal development, and chronic health problems in both mother and child.Components leading to healthy pregnancy outcome include healthy pre-pregnancy weight, appropriate weight gain and physical activity during pregnancy, consumption of a wide variety of foods, appropriate vitamin and mineral supplementation, avoidance of alcohol and other harmful substances, and safe food handling. Nutrition assessment needs to encompass changes in anthropometric,biochemical, and clinical indicators throughout pregnancy. Pregnant women should gain weight according to the 2009 Institute of Medicine Guidelines. Energy needs are no higher than the Estimated Energy Requirement for nonpregnant women until the second trimester; thereafter, the extra energy need per day is 340 kcal and 452 kcal in the second and third trimesters,respectively. Using the 2010 Dietary Guidelines for Americans, registered dietitian nutritionists and dietetics technicians, registered,can help pregnant women select a food plan based on age, physical activity, trimester, weight gain, and other considerations.Women are encouraged to participate in at least 150 minutes of moderate-intensity aerobic activity spread throughout the week or 30 minutes of moderately intense exercise on most days of the week.When good food choices are made, food consumption to meet extra energy needs and the increased absorption and efficiency of nutrient utilization that occurs in pregnancy are generally adequate to meet most nutrient needs. However, vitamin and mineral supplementation may be important in vulnerable cases including food insecurity; alcohol, tobacco, or other substance dependency; anemia; strict vegetarian (vegan) diet; or poor eating habits. Multiple strategies are needed to support healthy lifestyles for all women, from preconception through the postpartum period. This practice paper supports the Academy of Nutrition and Dietetics' position paper "Nutrition and Lifestyle for a Healthy Pregnancy Outcome" published in the July 2014 Journal of the Academy of Nutrition and Dietetics.
Teratology Public Affairs Committee position paper: maternal obesity and pregnancy. [2006]Compared to normal-weight women, obese women have an increased risk of infertility and pregnancy complications. The most consistently described pregnancy complications are hypertensive disorders, gestational diabetes mellitus, thromboembolic events, and cesarean section. Fetal and neonatal complications may include congenital malformations, macrosomia, and shoulder dystocia. The literature suggests that women with a body mass index (BMI) >or=30 have approximately double the risk of having a child with a neural tube defect (NTD) compared to normal-weight women, and the increased risk associated with higher maternal body weight does not appear to be modified by folic acid supplementation. The Public Affairs Committee of the Teratology Society supports the public health initiatives identified by the U.S. Food and Drug Administration in 2004 and the research initiatives identified by the National Institutes of Health in 2004. The Public Affairs Committee recommends that clinicians counsel women about appropriate caloric intake and exercise and that health-care providers educate parents about appropriate childhood nutrition. Breast-feeding should be encouraged based on evidence of a protective effect against childhood obesity, as well as other health advantages.
How can more women of childbearing age be encouraged to follow fish consumption recommendations? [2014]Several studies show that most women do not consume enough fish during pregnancy (and afterward) to derive the maximum health benefits for themselves and their babies, according to the USDA guidelines. We engaged in a two-part study to better understand what might be done to encourage women of childbearing age to eat healthy fish-a mail survey of women who recently gave birth in Minnesota, Wisconsin, and Pennsylvania, and six focus groups with women of childbearing age living in the Great Lakes region. Similar to other studies, we found that many women changed their behavior and consumed less fish during pregnancy than before. Most women reported receiving information, primarily during pregnancy, about the types of fish and how much fish to eat. As a result, increasing access to information during pregnancy likely would not result in increasing many women's fish consumption. Based on our examination of factors influencing women to try to follow the recommendations, the strongest connection with trying to follow the recommendations was receiving enough information to decide and believing that eating fish was good for the baby. Focus group participants also reported that messages about the specific health benefits of fish consumption for their children were particularly influential. These findings suggest that refining messages through testing might be a valuable approach toward increasing women's consumption of less-contaminated fish.
Care by Midwives, Obstetricians, and Dietitians for Pregnant Women Following a Strict Plant-Based Diet: A Cross-Sectional Study. [2021]With an growing number of people on a strict plant-based diet, its potential effect on pregnancy and lactation becomes increasingly important. It is, however, unclear how obstetric caregivers currently handle and think about a strict plant-based diet in pregnancy. The aim of the study was therefore to evaluate the self-reported knowledge and advice given by Dutch obstetric caregivers and dietitians when treating pregnant women on a strict plant-based diet. A cross-sectional study was performed by sending an online survey to Dutch midwife practices, obstetricians, and dietitian practices. Descriptive statistics are reported. A total of 121 midwives, 179 obstetricians, and 111 dietitians participated in this study. The majority of midwives (80.2%) and obstetricians (93.9%) considered a strict plant-based diet to be a significant risk factor for nutrient deficiency during pregnancy. Maternal dietary preferences, including a potential strict plant-based diet, were discussed at the first prenatal appointment by 59.5% of midwives and 24.1% of obstetricians. A self-reported lack of knowledge concerning the strict plant-based diet was mentioned by 66.1% of midwives and 75.4% of obstetricians. Obstetric caregivers mostly considered the identification of this dietary habit and subsequent referral to a dietitian or a reliable website as optimal care for pregnant women on the strict plant-based diet. However, only 38.7% of dietitians indicated to have sufficient knowledge to counsel these women. Although obstetric caregivers thought that a strict plant-based diet in pregnancy may lead to increased risks of nutritional deficiencies, the majority report to have insufficient knowledge to provide adequate advice. Only a minority referred these women to dietitians, of whom a minority indicated to have adequate knowledge on this specific diet. These results suggest that current care is suboptimal for an increasing number of pregnant women. Women on a strict plant-based diet could benefit from increased knowledge about this topic among obstetric caregivers and dietitians, as well as from clear guidelines regarding this diet during pregnancy.
Fish consumption and advisory awareness among expectant women. [2006]During the spring of 2003, the Wisconsin Department of Health and Family Services (DHFS) piloted a fish consumption advisory program targeted at pregnant women. Fish consumption recommendations and information about the prenatal effects of methylmercury were illustrated in multilingual posters, brochures, fact cards, and other promotional items. These materials were mailed to Women, Infants and Children (WIC) program providers, local health departments, and medical clinics, along with a cover letter that encouraged them to display the materials in waiting areas and distribute them to new mothers and expectant women who visited their facilities. In August 2003, a survey was mailed to 1000 women who had given birth during the first week of June 2003. The survey was intended to provide an estimate of the number and types of fish meals the women had consumed during pregnancy and evaluate their familiarity with the outreach materials. On average, survey respondents consumed 3 fish meals a month. The most frequently consumed fish were canned tuna and frozen fish. Approximately one third of women knew that older fish and predatory fish have the highest levels of mercury. While almost half of the women were aware of Wisconsin's sport fish advisory, only 13% of them remembered seeing any of the outreach materials.
The National WIC Evaluation: evaluation of the Special Supplemental Food Program for Women, Infants, and Children. V. Longitudinal study of pregnant women. [2018]The major associations with the Special Supplemental Food Program for Women, Infants, and Children (WIC) in pregnancy were increased intake of protein, iron, calcium, and vitamin C (four of five targeted nutrients) and of energy, magnesium, phosphorus, thiamin, riboflavin, niacin, vitamin B-6, and vitamin B-12; reversal of low weight gain in early pregnancy; smaller fat stores in late pregnancy; reduced frequency of premature rupture of the uterine membranes; larger infant head circumference with no effect on birth weight and length; increased birth weight and head circumference with better program quality; and lower fetal mortality of appreciable but not significant magnitude. Incremental energy intake was comparable to that in most small-scale supplementation trials. There was no evidence of effects on frequency of prenatal care, use of alcohol or tobacco, the intention to breast-feed, or the rate of breast-feeding. Maternal alcohol intake was associated with depressed infant head circumference, over and above effects on birth weight and length.
Infant milk-feeding practices and diagnosed celiac disease and inflammatory bowel disease in offspring: a systematic review. [2023]During the Pregnancy and Birth to 24 Months Project, the USDA and US Department of Health and Human Services initiated an evidence review on diet and health in these populations.