Food as Medicine Interventions for Postpartum Women in Central Texas

This study is looking at ways to help postpartum women in Central Texas who are experiencing food insecurity (not having enough food). It compares two approaches: "FBM-In person," where you'd get home visits from a Community Health Worker (CHW) to connect you with resources, and "FBM-Virtual," which gives you access to an online platform and a private Facebook group for support and information. Some participants will also receive weekly deliveries of food boxes. The study aims to see how these interventions affect your diet quality, food security, and breastfeeding rates. You could join if you are a food-insecure woman between 18 and 45 years old, can communicate in English or Spanish, and live within the food delivery area. The study's current status is unclear.

Study design
This interventional study plans to enroll 100 women. It compares two different approaches to providing support and resources.
What's involved
Participants in FBM-In person will have two 30-minute home visits. Participants receiving home-delivered food boxes will get weekly deliveries. Assessments will be done at the start, immediately after the intervention, and three months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after the intervention ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06428578

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

UNKNOWN
NAAges 18–45InterventionalTreatment
The University of Texas Health Science Center, Houston
~100 participants
Updated 2024-05-24 on ClinicalTrials.gov
What's tested:FBM-In personFBM-Virtualhome delivered food boxes

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire
Measured over Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
+8 more outcomes measured
Food Insecurity in Post Partum Women

NCT06428578

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascension Seton Medical Center

    Austin, Texasstudy coordinator listed

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Alexandra van den Berg, MPH, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

food insecure
to communicate in English or Spanish.

Exclusion

not living within the food produce zip code delivery radius
having any dietary allergies.
  • 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 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 questionnaireBaseline, 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 questionnaireBaseline
  • Total duration of breastfeeding time as assessed by the post test questionnairesend of study (after 8 weeks of food delivery boxes)
  • Total duration of breastfeeding time as assessed by the post test questionnaires3 months follow up
  • 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 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 weekBaseline, 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 questionnaireBaseline, 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 ScaleBaseline, 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.