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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
800
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
College Station, Texas, United States
RECRUITINGTexas A&M AgriLife Research Institute for Advancing Health Through Agriculture
Dallas, Texas, United States
RECRUITINGTexas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center
Mansfield, Texas, United States
Healthy Eating Index
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).
Time frame: Baseline to 6 weeks postpartum
Blood Concentration of Hemoglobin A1C (HbA1C)
Measures average blood sugar levels over the past 2-3 months, acting as a key diagnostic tool for diabetes and prediabetes.
Time frame: Baseline to 6 weeks postpartum
Blood Concentration of High-Sensitivity C-Reactive Protein (hsCRP)
Measures very low levels of C-reactive protein to detect chronic inflammation, primarily assessing cardiovascular disease (CVD) risk.
Time frame: Baseline to 6 weeks postpartum
Gestational weight gain
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.
Time frame: Baseline to delivery
Postpartum weight retention
Measured in pounds or kilograms at 6 weeks postpartum.
Time frame: Baseline to 6 weeks postpartum
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