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Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies

RECRUITINGN/ASponsored by Texas A&M University
Actively Recruiting
PhaseN/A
SponsorTexas A&M University
Started2026-06-22
Est. completion2028-07-31
Eligibility
Age18 Years – 45 Years
SexFEMALE
Healthy vol.Accepted
Locations3 sites

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.

Eligibility

Age: 18 Years – 45 YearsSex: FEMALEHealthy volunteers accepted
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)

Conditions2

DiabetesPregnant Women With Singleton Pregnancies

Locations3 sites

Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
College Station, Texas, 77840
Erica Bender, MSN, CNM, NP-Ob/Gyn979-314-8742erica.bender@ag.tamu.edu
Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
Dallas, Texas, 75252
Erica Bender, MSN, CNM, NP-Ob/Gyn979-314-8742erica.bender@ag.tamu.edu
Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center
Mansfield, Texas, 76063
Erica Bender, MSN, CNM, NP-Ob/Gyn979-314-8742erica.bender@ag.tamu.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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