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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06428578
Enrollment
100
Registered
2024-05-24
Start date
2024-01-01
Completion date
2025-06-30
Last updated
2024-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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 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.

Interventions

OTHERFBM-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.

OTHERFBM-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.

OTHERhome 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.

Sponsors

American Heart Association
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaireBaseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of interventionThis 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 questionnaireBaseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of interventionThis 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 questionnaireBaseline
Total duration of breastfeeding time as assessed by the post test questionnairesend of study (after 8 weeks of food delivery boxes)
Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of interventionThis 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 weekBaseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of interventionParticipant 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 questionnaireBaseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of interventionScores 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 ScaleBaseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of interventionA single item from the Financial Self Efficacy scale will be used.

Countries

United States

Contacts

Primary ContactAlexandra van den Berg, MPH, PhD
Alexandra.E.VanDenBerg@uth.tmc.edu(512) 391-2529
Backup ContactAida Nielsen, MPH
Aida.Nielsen@uth.tmc.edu(512) 482-6183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026