Food Insecurity in Post Partum WomenNCT06428578
Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
A study testing FBM-In person, FBM-Virtual and home delivered food boxes in people with Food Insecurity in Post Partum Women, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Food Insecurity in Post Partum Women
- What is being tested?
- FBM-In person, FBM-Virtual and home delivered food boxes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- food insecure
- to communicate in English or Spanish.
Who cannot join
- not living within the food produce zip code delivery radius
- having any dietary allergies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Ascension Seton Medical Center
Austin, Texas, 78705
Alexandra van den Berg, MPH,PhD, 512-391-2529, Alexandra.E.VanDenBerg@uth.tmc.edu
Aida Nielsen, MPH, (512) 482-6183, Aida.Nielsen@uth.tmc.edu
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Alexandra van den Berg, MPH, PhD, 512-391-2529, Alexandra.E.VanDenBerg@uth.tmc.edu
Aida Nielsen, (512) 482-6160, Aida.Nielsen@uth.tmc.edu
About this study
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.
- Conditions
- Food Insecurity in Post Partum Women
- Being tested
- FBM-In person, FBM-Virtual, home delivered food boxes
- Keywords
- Food is Medicine (FIM), food insecurity, free delivered nutritious meals, food boxes, Community Health Workers, The University of Texas Health Science Center at Houston School of Public Health, Austin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBM-In personOther
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.
FBM-VirtualOther
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 boxesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FBM-In person | Experimental | Not described Receives: Other: FBM-In person; Other: home delivered food boxes |
| FBM-Virtual | Experimental | Not described Receives: Other: FBM-Virtual; Other: home delivered food boxes |
| home delivered food | Active comparator | Not described Receives: Other: home delivered food boxes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire
This is an 6 item questionnaire . Raw score will be reported and score ranges from 0-6. Raw score of 0-1 shows high or marginal food security, raw score of 2- indicates low food security and raw score of 5-6 shows very low food insecurity.
Measured: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Change in quality of diet as assessed by number of times participants ate certain food items in the past month as reported in the questionnaire
This data will be reported categorically for 14 different food items as follows:
- fruit
- green leafy or lettuce salad
- fried potatoes
- other kind of potatoes
- refired/baked/ cooked beans
- other vegetables that were not deep-fried
- salsa made with tomato
- pizza
- tomato sauce
- lean protein
- plant-based protein
- brown rice or other cooked whole grains
- whole grain bread
- regular soda/pop
Measured: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Number of participants that initiated breastfeeding as assessed by the pre test questionnaire
Measured: Baseline
Total duration of breastfeeding time as assessed by the post test questionnaires
Measured: end of study (after 8 weeks of food delivery boxes)
Total duration of breastfeeding time as assessed by the post test questionnaires
Measured: 3 months follow up
Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
This is a 10 item questionnaire , range of score for each item is 0-3 for a total score range of 0-30, score above 12 is worse outcome
Measured: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week
Participant will be asked how often he/she or anyone else in the family prepared breakfast from scratch during the past week, lunch from scratch during the past week or dinner from scratch during the past week. The responses from the 3 items will be summed to determine the number of home cooked meals during past week.
Measured: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Change in financial stress as assessed by the financial stress questionnaire
Scores for three questions from the Financial Stress Scale will be used and each will be scored from 0(never) to 6(Always) for a score range of 0-18; 18 being highest level of financial stress.
Measured: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Percentage of participants that face financial challenges as assessed by the Financial Self-Efficacy Scale
A single item from the Financial Self Efficacy scale will be used.
Measured: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food Insecurity in Post Partum WomenStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Alexandra van den Berg, The University of Texas Health Science Center, Houston
- Investigators
- Alexandra van den Berg, MPH, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428578
- Sponsor's protocol ID
- HSC-SPH-23-0795
- Other IDs
- 24FIM1264463
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nielsen A, Falzone A, Reyes C, Polinard E, Threadgould V, Ranjit N, Marin MD, Gonzalez A, Tello M, Abel A, Chevalier J, Fischweicher A, van den Berg A. Food is the Best Medicine (FBM): design and baseline findings from a multi-arm randomized controlled trial among food-insecure postpartum mothers in Texas. BMC Nutr. 2026 Jun 30. doi: 10.1186/s40795-026-01406-0. Online ahead of print.
PubMed 42374551
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
- ClinicalTrials.gov ID
- NCT06428578
- Acronym / sponsor ID
- HSC-SPH-23-0795
- Conditions
- Food Insecurity in Post Partum Women
- Keywords
- Food is Medicine (FIM), food insecurity, free delivered nutritious meals, food boxes, Community Health Workers, The University of Texas Health Science Center at Houston School of Public Health, Austin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 May 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FBM-In person | Experimental | Other: FBM-In person, Other: home delivered food boxes |
| FBM-Virtual | Experimental | Other: FBM-Virtual, Other: home delivered food boxes |
| home delivered food | Active comparator | Other: home delivered food boxes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- food insecure
- to communicate in English or Spanish.
Key exclusion criteria (2 listed)
- not living within the food produce zip code delivery radius
- having any dietary allergies.
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 |
|---|---|---|
| FBM-In personParticipants 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. | Other | FBM-In person |
| FBM-VirtualParticipants 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. | Other | FBM-Virtual |
| home delivered food boxesParticipants 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. | Other | FBM-In person, FBM-Virtual, home delivered food |
Primary outcome
Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire
Time frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
This is an 6 item questionnaire . Raw score will be reported and score ranges from 0-6. Raw score of 0-1 shows high or marginal food security, raw score of 2- indicates low food security and raw score of 5-6 shows very low food insecurity.
Change in quality of diet as assessed by number of times participants ate certain food items in the past month as reported in the questionnaire
Time frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
This data will be reported categorically for 14 different food items as follows: 1. fruit 2. green leafy or lettuce salad 3. fried potatoes 4. other kind of potatoes 5. refired/baked/ cooked beans 6. other vegetables that were not deep-fried 7. salsa made with tomato 8. pizza 9. tomato sauce 10. lean protein 11. plant-based protein 12. brown rice or other cooked whole grains 13. whole grain bread 14. regular soda/pop
Number of participants that initiated breastfeeding as assessed by the pre test questionnaire
Time frame: Baseline
Total duration of breastfeeding time as assessed by the post test questionnaires
Time frame: end of study (after 8 weeks of food delivery boxes)
Total duration of breastfeeding time as assessed by the post test questionnaires
Time frame: 3 months follow up
Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
This is a 10 item questionnaire , range of score for each item is 0-3 for a total score range of 0-30, score above 12 is worse outcome
Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week
Time frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Participant will be asked how often he/she or anyone else in the family prepared breakfast from scratch during the past week, lunch from scratch during the past week or dinner from scratch during the past week. The responses from the 3 items will be summed to determine the number of home cooked meals during past week.
Change in financial stress as assessed by the financial stress questionnaire
Time frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Scores for three questions from the Financial Stress Scale will be used and each will be scored from 0(never) to 6(Always) for a score range of 0-18; 18 being highest level of financial stress.
Percentage of participants that face financial challenges as assessed by the Financial Self-Efficacy Scale
Time frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
A single item from the Financial Self Efficacy scale will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 42374551Nielsen A, Falzone A, Reyes C, Polinard E, Threadgould V, Ranjit N, Marin MD, Gonzalez A, Tello M, Abel A, Chevalier J, Fischweicher A, van den Berg A. Food is the Best Medicine (FBM): design and baseline findings from a multi-arm randomized controlled trial among food-insecure postpartum mothers in Texas. BMC Nutr. 2026 Jun 30. doi: 10.1186/s40795-026-01406-0. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alexandra van den Berg, MPH, PhD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBM-In person, FBM-Virtual and home delivered food boxes in people with Food Insecurity in Post Partum Women, run by The University of Texas Health Science Center, Houston at 2 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra van den Berg, MPH, PhD ((512) 391-2529, Alexandra.E.VanDenBerg@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire (time frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428578, which also lists 1 linked publication.
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 24 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.