An interventional study of Food Kit in Pregnant Women With Singleton Pregnancies, sponsored by Texas A&M University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Texas A&M University · Not applicable, Interventional, and Prevention
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.
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:
Participants will:
134 studies on the registry are indexed under Gestational Weight Gain; 24 are open to participants now.
This study's planned enrollment of 800 is above the median of 104 across 108 interventional studies indexed under Gestational Weight Gain.
Browse Gestational Weight Gain studies →Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Food Kit
Control participants will submit verification that they are receiving or intend to receive standard prenatal care (not study provided).
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
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
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
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
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
Postpartum weight retention
Measured in pounds or kilograms at 6 weeks postpartum.
Time frame: Baseline to 6 weeks postpartum
Plan to share: Yes — Deidentified individual participant data, including quantitative and qualitative human health and behavioral data collected via survey, clinical assessment, and related methods, will be made available to qualified researchers upon request. Data will be shared in open, non-proprietary formats (e.g., .csv for tabular data; .txt/.doc for text/qualitative data) accompanied by a file documenting experimental design, data collection methods, software/versions used for processing, variable/column definitions, and units or abbreviations. No personally identifiable information will be shared. Prior to release, datasets will be reviewed for intellectual property, patent, or proprietary constraints. Access will require execution of a data use agreement, approved manuscript proposal plan with statistical analysis details, and approval by the study's data access committee, which will evaluate requests to balance scientific value with participant privacy and the terms of informed consent.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 24 months following publication of the primary outcome and three key secondary outcome papers and for at least 3 years following project completion.
Access criteria: Requests will be reviewed by the PIs (Seguin-Fowler, Bender, Shankar) and/or designated data access committee. Researchers must submit a written proposal describing the scientific rationale and intended use, and must agree to a data use agreement governing confidentiality, security, and citation requirements. Approved users will receive deidentified data along with a data dictionary and the study protocol. Users are required to cite the dataset in any resulting peer-reviewed publications. Requests and inquiries should be directed to the study PI or designated contact listed in the trial registry record and associated publications.
Data sharing details ↗ · harvestinghealthstudy.org
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jul 2028, 25 months after the start.
Of 84 non-industry interventional studies with no phase under Gestational Weight Gain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's planned 25 months is close to that.
Counting every sponsor, half of 84 studies reached it within 24 months; a quarter within 13 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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