Pregnant Women With Singleton PregnanciesHHNCT07659821
Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies
A study testing Food Kit in people with Pregnant Women With Singleton Pregnancies, run by Texas A&M University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women With Singleton Pregnancies
- What is being tested?
- Food Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jun 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
College Station, Texas, 77840
Erica Bender, MSN, CNM, NP-Ob/Gyn, 979-314-8742, erica.bender@ag.tamu.edu
Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
- Recruiting
Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
Dallas, Texas, 75252
Erica Bender, MSN, CNM, NP-Ob/Gyn, 979-314-8742, erica.bender@ag.tamu.edu
Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
- Recruiting
Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center
Mansfield, Texas, 76063
Erica Bender, MSN, CNM, NP-Ob/Gyn, 979-314-8742, erica.bender@ag.tamu.edu
Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
About this study
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.
Read the 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 submit verification that they are receiving or intend to receive 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 submit verification that they are receiving or intend to receive standard 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 a food kit that can be updated and personalized every two weeks within designated food categories and amounts.
- Being tested
- Food Kit
- Keywords
- Diet quality, Pregnancy, Postpartum, Maternal outcomes, Birth outcomes, Gestational Weight Gain, Postpartum weight retention, Preeclampsia, Gestational Diabetes Mellitus (GDM)
- Medical subject headings
- Gestational Weight Gain, Pre-Eclampsia, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food KitOther
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Harvesting Health Food Kit Intervention) | Experimental | 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). Receives: Other: Food Kit |
| Group 2 (Usual care/control) | No intervention | Control participants will submit verification that they are receiving or intend to receive standard prenatal care (not study provided). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 6 weeks postpartum
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to delivery
Postpartum weight retention
Measured in pounds or kilograms at 6 weeks postpartum.
Measured: Baseline to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start22 Jun 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women With Singleton PregnanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two groups: 1. Intervention Group: Receives the Harvesting Health Food Kit; also submits verification that they are receiving or intend to receive standard prenatal care (not study provided). 2. Control Group: Submits verification that they are receiving or intend to receive standard prenatal care (not study provided).
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Dr. Rebecca Seguin-Fowler, Texas A&M University
- Investigators
- Rebecca L Seguin-Fowler, PhD, RDN, LD, CSCS, Principal investigator, Texas A&M AgriLife ResearchErica Bender, MSN, CNM, NP-Ob/Gyn, Principal investigator, Texas A&M AgriLife Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659821
- Sponsor's protocol ID
- 2025-1307
- Other IDs
- 58-3091-2-025
- Acronym
- HH
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies
- ClinicalTrials.gov ID
- NCT07659821
- Acronym / sponsor ID
- HH / 2025-1307
- Keywords
- Diet quality, Pregnancy, Postpartum, Maternal outcomes, Birth outcomes, Gestational Weight Gain, Postpartum weight retention, Preeclampsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 submit verification that they are receiving or intend to receive 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 submit verification that they are receiving or intend to receive standard 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 a food kit that can be updated and personalized every two weeks within designated food categories and amounts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two groups: 1. Intervention Group: Receives the Harvesting Health Food Kit; also submits verification that they are receiving or intend to receive standard prenatal care (not study provided). 2. Control Group: Submits verification that they are receiving or intend to receive standard prenatal care (not study provided).
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Harvesting Health Food Kit Intervention) | Experimental | Other: Food KitFor 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). |
| Group 2 (Usual care/control) | No intervention | –Control participants will submit verification that they are receiving or intend to receive standard prenatal care (not study provided). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food KitBiweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats. | Other | Group 1 (Harvesting Health Food Kit Intervention) |
Primary outcome
Healthy Eating Index
Time frame: Baseline to 6 weeks postpartum
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).
4 secondary outcomes
Blood Concentration of Hemoglobin A1C (HbA1C)
Time frame: Baseline to 6 weeks postpartum
Blood Concentration of High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline to 6 weeks postpartum
Gestational weight gain
Time frame: Baseline to delivery
Postpartum weight retention
Time frame: Baseline to 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca L Seguin-Fowler, PhD, RDN, LD, CSCS principal investigator
Texas A&M AgriLife Research
Erica Bender, MSN, CNM, NP-Ob/Gyn principal investigator
Texas A&M AgriLife Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Kit in people with Pregnant Women With Singleton Pregnancies, run by Texas A&M University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS (979-845-8486, r.seguin-fowler@ag.tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Eating Index (time frame: Baseline to 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.