Recruiting

Personalized Food Kit

Sponsor:

Texas A&M University

Code:

NCT07659821

Conditions

Pregnant Women With Singleton Pregnancies

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Food Kit

Study Details

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.

Conditions

Pregnant Women With Singleton Pregnancies

Study ID

NCT07659821

Start date

Jun 22, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy 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)

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1 (Harvesting Health Food Kit Intervention)

For the intervention group, participation in the food kit (distributed every 2 weeks) will begin in the 1st trimester and end with 2-3 kits postpartum (last kit at 6 weeks). Final data collection is scheduled at/around 12 weeks postpartum. Participants choose all of their food kit contents within specified categories and amounts. Participants will also submit verification that they are receiving or intend to receive standard prenatal care (not study provided).

no intervention: Group 2 (Usual care/control)

Control participants will submit verification that they are receiving or intend to receive standard prenatal care (not study provided).

Interventions

Food Kit

Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.

Primary outcome measure

  • Healthy Eating Index [ Time Frame: Baseline to 6 weeks postpartum ]

Central Contacts and Locations

Central contacts

Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS

979-845-8486r.seguin-fowler@ag.tamu.edu

Erica Bender, MSN, CNM, NP-Ob/Gyn

979-314-8742erica.bender@ag.tamu.edu

Locations

Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture

Recruiting

College Station, Texas, United States, 77840

Contacts

Erica Bender, MSN, CNM, NP-Ob/Gyn

979-314-8742erica.bender@ag.tamu.edu

Principal Investigator:

Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS

Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture

Recruiting

Dallas, Texas, United States, 75252

Contacts

Erica Bender, MSN, CNM, NP-Ob/Gyn

979-314-8742erica.bender@ag.tamu.edu

Principal Investigator:

Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS

Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center

Recruiting

Mansfield, Texas, United States, 76063

Contacts

Erica Bender, MSN, CNM, NP-Ob/Gyn

979-314-8742erica.bender@ag.tamu.edu

Principal Investigator:

Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS

More Information

Sponsor

Texas A&M University

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Diet quality
  • Pregnancy
  • Postpartum
  • Maternal outcomes
  • Birth outcomes
  • Gestational Weight Gain
  • Postpartum weight retention
  • Preeclampsia
  • Gestational Diabetes Mellitus (GDM)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas A&M University on 2026-06-30.