Health TrialsbyHealthPanel

Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies

ConditionPregnant Women With Singleton Pregnancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTexas A&M University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Food Kit

    Other intervention

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

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Group 1 (Harvesting Health Food Kit Intervention)Experimental treatment 1 intervention
Group B: Group 2 (Usual care/control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Postpartum weight retention

Measured in pounds or kilograms at 6 weeks postpartum.

Time frame
Baseline to 6 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas A&M University

Lead sponsor

United States Department of Agriculture (USDA)

Collaborator

Source ClinicalTrials.gov
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