Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food Kit.
- Who it may be relevant to
- Registry conditions: Pregnant Women With Singleton Pregnancies. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Food Kit
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
Primary outcome measures
- Healthy Eating Index [Time frame: Baseline to 6 weeks postpartum]
Secondary outcome measures (4)
- Blood Concentration of Hemoglobin A1C (HbA1C) [Time frame: Baseline to 6 weeks postpartum]
- Blood Concentration of High-Sensitivity C-Reactive Protein (hsCRP) [Time frame: Baseline to 6 weeks postpartum]
- Gestational weight gain [Time frame: Baseline to delivery]
- Postpartum weight retention [Time frame: Baseline to 6 weeks postpartum]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 3 centers
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture — College Station
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture — Dallas
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist — Mansfield
Identifiers
NCT: NCT07659821 · 2025-1307 · 58-3091-2-025