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

26 juin 2026 mis à jour par: Dr. Rebecca Seguin-Fowler, Texas A&M University
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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

800

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Texas
      • College Station, Texas, États-Unis, 77840
        • Recrutement
        • Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
        • Contact:
        • Chercheur principal:
          • Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
        • Chercheur principal:
          • Erica Bender, MSN, CNM, NP-Ob/Gyn
      • Dallas, Texas, États-Unis, 75252
        • Recrutement
        • Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
        • Contact:
        • Chercheur principal:
          • Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
        • Chercheur principal:
          • Erica Bender, MSN, CNM, NP-Ob/Gyn
      • Mansfield, Texas, États-Unis, 76063
        • Recrutement
        • Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center
        • Contact:
        • Chercheur principal:
          • Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
        • Chercheur principal:
          • Erica Bender, MSN, CNM, NP-Ob/Gyn

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La 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, 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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Autre: Food Kit
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
Aucune 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Healthy Eating Index
Délai: 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).
Baseline to 6 weeks postpartum

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Blood Concentration of Hemoglobin A1C (HbA1C)
Délai: Baseline to 6 weeks postpartum
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
Gestational weight gain
Délai: Baseline to delivery
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.
Baseline to delivery
Blood Concentration of High-Sensitivity C-Reactive Protein (hsCRP)
Délai: Baseline to 6 weeks postpartum
Measures very low levels of C-reactive protein to detect chronic inflammation, primarily assessing cardiovascular disease (CVD) risk.
Baseline to 6 weeks postpartum
Postpartum weight retention
Délai: Baseline to 6 weeks postpartum
Measured in pounds or kilograms at 6 weeks postpartum.
Baseline to 6 weeks postpartum

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Texas A&M University

Collaborateurs

United States Department of Agriculture (USDA)

Les enquêteurs

  • Chercheur principal: Rebecca L Seguin-Fowler, PhD, RDN, LD, CSCS, Texas A&M AgriLife Research
  • Chercheur principal: Erica Bender, MSN, CNM, NP-Ob/Gyn, Texas A&M AgriLife Research

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 juin 2026

Achèvement primaire (Estimé)

31 juillet 2028

Achèvement de l'étude (Estimé)

31 juillet 2028

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

22 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2025-1307
  • 58-3091-2-025 (Autre subvention/numéro de financement: United States Department of Agriculture- Agricultural Research Service)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

Beginning 24 months following publication of the primary outcome and three key secondary outcome papers and for at least 3 years following project completion.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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