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

Not Applicable
Recruiting
Conditions
Food Insecurity in Post Partum Women
Interventions
Other: FBM-Virtual
Other: FBM-In person
Other: home delivered food boxes
Registration Number
NCT06428578
Lead Sponsor
The University of Texas Health Science Center, Houston
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FBM-In personhome delivered food boxes-
FBM-VirtualFBM-Virtual-
home delivered foodhome delivered food boxes-
FBM-In personFBM-In person-
FBM-Virtualhome delivered food boxes-
Primary Outcome Measures
NameTimeMethod
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

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.

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.

Total duration of breastfeeding time as assessed by the post test questionnaires3 months follow up
Number of participants that initiated breastfeeding as assessed by the pre test questionnaireBaseline
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.

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

Ascension Seton Medical Center

🇺🇸

Austin, Texas, United States

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