Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas

NCT ID: NCT06428578

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-30

Brief Summary

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The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations.

Detailed Description

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Conditions

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Food Insecurity in Post Partum Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FBM-In person

Group Type EXPERIMENTAL

FBM-In person

Intervention Type OTHER

Participants will receive two home visits by a CHW. Each home visit will last about 30 minutes, during which the CHW will assist the woman with community resources and help with enrolling in any state or federal nutrition and medical programs. Furthermore, the participants will be given access to a private Facebook group for nutrition, health education, and social support. Home visits will occur during the second and fifth weeks of the study.

home delivered food boxes

Intervention Type OTHER

Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.

FBM-Virtual

Group Type EXPERIMENTAL

FBM-Virtual

Intervention Type OTHER

Participants will receive access to a virtual platform which will have information on national, state, and local food and medical resources, as well as local community resources, and will have access to a private Facebook group for nutrition, health education, and social support.

home delivered food boxes

Intervention Type OTHER

Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.

home delivered food

Group Type ACTIVE_COMPARATOR

home delivered food boxes

Intervention Type OTHER

Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.

Interventions

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FBM-In person

Participants will receive two home visits by a CHW. Each home visit will last about 30 minutes, during which the CHW will assist the woman with community resources and help with enrolling in any state or federal nutrition and medical programs. Furthermore, the participants will be given access to a private Facebook group for nutrition, health education, and social support. Home visits will occur during the second and fifth weeks of the study.

Intervention Type OTHER

FBM-Virtual

Participants will receive access to a virtual platform which will have information on national, state, and local food and medical resources, as well as local community resources, and will have access to a private Facebook group for nutrition, health education, and social support.

Intervention Type OTHER

home delivered food boxes

Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* food insecure
* to communicate in English or Spanish.

Exclusion Criteria

* not living within the food produce zip code delivery radius
* having any dietary allergies.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Alexandra van den Berg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandra van den Berg, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Ascension Seton Medical Center

Austin, Texas, United States

Site Status RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alexandra van den Berg, MPH, PhD

Role: CONTACT

(512) 391-2529

Aida Nielsen, MPH

Role: CONTACT

(512) 482-6183

Facility Contacts

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Alexandra van den Berg, MPH,PhD

Role: primary

512-391-2529

Aida Nielsen, MPH

Role: backup

(512) 482-6183

Alexandra van den Berg, MPH, PhD

Role: primary

512-391-2529

Aida Nielsen

Role: backup

(512) 482-6160

Other Identifiers

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24FIM1264463

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC-SPH-23-0795

Identifier Type: -

Identifier Source: org_study_id

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