Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies (HH)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnant Women With Singleton Pregnancies
• Intervention / Treatment: Other: Food Kit

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 are receiving 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 confirm that they are receiving usual 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 the food kit that can be updated and personalized every two weeks within designated food categories and amounts.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS; Phone Number: (979) 845-8486; Email: r.seguin-fowler@ag.tamu.edu
• Study Contact Backup: Name: Erica Bender, MSN, CNM, NP-Ob/Gyn; Phone Number: 979-314-8742; Email: erica.bender@ag.tamu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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, or Rockwall 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Food Kit; Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
No Intervention: Group 2 (Usual care/control); Control participants will continue usual prenatal care. Usual prenatal care follows the guidance of the American College of Obstetricians and Gynecologists (ACOG) for low-risk pregnancies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy Eating Index	Ranging from 0 to 100, a higher 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 NDSR.	Baseline to 6 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C	Measures average blood sugar levels over the past 2-3 months, acting as a key diagnostic tool for diabetes and prediabetes.	Baseline to 6 weeks postpartum
hsCRP	Measures very low levels of C-reactive protein to detect chronic inflammation, primarily assessing cardiovascular disease (CVD) risk	Baseline to 6 weeks postpartum
Gestational weight gain	Measured in pounds or kilograms. Guidelines suggest 25-35 lbs for normal weight, 28-40 lbs for underweight, 15-25 lbs for overweight, and 11-20 lbs for obese individuals.	Baseline to delivery
Postpartum weight retention	Measured in pounds or kilograms at 6 weeks postpartum	Baseline to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Texas A&M University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum; Diet quality; Preeclampsia; Maternal outcomes; Gestational Weight Gain; Birth outcomes; Postpartum weight retention; Gestational Diabetes Mellitus (GDM)
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Body Weight; Pregnancy Complications; Body Weight Changes; Glucose Metabolism Disorders; Diabetes Mellitus; Hypertension, Pregnancy-Induced; Weight Gain; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Gestational Weight Gain; Diabetes, Gestational; Pre-Eclampsia
• Other Study ID Numbers: 2025-1307; 58-3091-2-025 (Other Grant/Funding Number: United States Department of Agriculture- Agricultural Research Service)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No