Pregnant Women With Singleton Pregnancies
Conditions
Keywords
Diet quality, Pregnancy, Postpartum, Maternal outcomes, Birth outcomes, Gestational Weight Gain, Postpartum weight retention, Preeclampsia, Gestational Diabetes Mellitus (GDM)
Brief summary
This is a randomized controlled trial to assess whether a personalized food kit to pregnant women is feasible, improves diet quality, and enhances pregnancy and birth outcomes compared to standard prenatal care.
Detailed description
The goal of this clinical trial is to examine the effects of a personalized food kit on diet quality and pregnancy outcomes in pregnant women. The main questions it aims to answer are: * Does receiving the food kit improve the quality of a mother's diet and specified pregnancy outcomes, compared to standard prenatal care? * Researchers will compare participants who receive the Harvesting Health Food Kit (intervention group) with those who do not; all participants submit verification that they are receiving or intend to receive standard prenatal care. From an implementation evaluation perspective the study will address logistical issues (frequency, ease of use and utilization) of a personalized food kit in pregnancy. Participants will: * Be randomly assigned to either receive the food kit or not (all participants submit verification that they are receiving or intend to receive standard prenatal care, which is not provided by the study). * Attend regular study visits for clinical data collection and complete questionnaires about their diet and health. * (Intervention group only) Order and receive and a food kit that can be updated and personalized every two weeks within designated food categories and amounts.
Interventions
OTHERFood Kit
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
Sponsors
Texas A&M University
United States Department of Agriculture (USDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized to one of two groups: 1. Intervention Group: Receives the Harvesting Health Food Kit; also submits verification that they are receiving or intend to receive standard prenatal care (not study provided). 2. Control Group: Submits verification that they are receiving or intend to receive standard prenatal care (not study provided).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant individuals 7-12 weeks of gestation at the time of enrollment * Aged 18-45 years * Carrying a singleton pregnancy * Able to read and speak in English or Spanish * Reside and plan to receive prenatal and postpartum care within the Dallas-Fort Worth (DFW) metropolitan area or College Station area. * Willing to travel to Collin, Dallas, Denton, Ellis, Kaufman, Rockwall, or Tarrant counties for in-person data collection visits * Willing to receive the food kit from local partners through delivery or in-person pick-up, as applicable * Verification of established or planned prenatal care with a prenatal healthcare provider * Access to a smartphone * Willing and able to provide informed consent
Exclusion criteria
* Diagnosis of pre-existing type 1 diabetes * Significant chronic medical conditions that might impact pregnancy outcomes or study participation (e.g., severe hypertension, renal disease) * Multiple gestation * Fetal anomaly * History of bariatric surgery or other conditions that affect nutrient absorption * Current eating disorder * Current use of exclusionary medications (i.e., systemic steroids or anti-seizure medications) * Continued use of weight loss medication * Substance use disorder * Current or planned enrollment in another intervention study of any type * Inability to comply with study procedures (e.g., cognitive impairment, plan to move away before study completion, loss of pregnancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthy Eating Index | Baseline to 6 weeks postpartum | Ranging from 0 to 100, a higher Healthy Eating Index {HEI) score indicates a diet rich in healthy components (fruits, vegetables, whole grains) and lower in moderation components (sodium, added sugars, saturated fats). Calculated from 24-hour recalls collected via Nutrition Data System for Research (NDSR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Concentration of Hemoglobin A1C (HbA1C) | Baseline to 6 weeks postpartum | Measures average blood sugar levels over the past 2-3 months, acting as a key diagnostic tool for diabetes and prediabetes. |
| Blood Concentration of High-Sensitivity C-Reactive Protein (hsCRP) | Baseline to 6 weeks postpartum | Measures very low levels of C-reactive protein to detect chronic inflammation, primarily assessing cardiovascular disease (CVD) risk. |
| Gestational weight gain | Baseline to delivery | Measured in pounds or kilograms. Guidelines suggest 25-35 pounds (lbs) for normal weight, 28-40 lbs for underweight, 15-25 lbs for overweight, and 11-20 lbs for obese individuals. |
| Postpartum weight retention | Baseline to 6 weeks postpartum | Measured in pounds or kilograms at 6 weeks postpartum. |
Countries
United States
Contacts
CONTACTRebecca Seguin-Fowler, PhD, RDN, LD, CSCS
CONTACTErica Bender, MSN, CNM, NP-Ob/Gyn
PRINCIPAL_INVESTIGATORRebecca L Seguin-Fowler, PhD, RDN, LD, CSCS
Texas A&M AgriLife Research
PRINCIPAL_INVESTIGATORErica Bender, MSN, CNM, NP-Ob/Gyn
Texas A&M AgriLife Research
Outcome results
None listed